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Clinical Research Coordinator    Job Summary: The Clinical Research Coordinator (CRC) works with the Dignity Health Research Institute Market Clinical Research Manager (MCRM), Principal Investigators, co- and sub-investigators, clinical and ancillary departments, IRBs, and industry or government sponsors of research to plan, coordinate, implement and complete clinical trials and other research projects managed by the Dignity Health Research Institute. The incumbent independently manages all aspects of multiple clinical trials or other research projects as assigned, including but not limited to: research participant recruitment, screening and enrollment; completion of protocol required visits and procedures; collection and reporting of data; coordination of and participation in sponsor monitoring visits or federal audits; query resolution; adverse event reporting, source documentation and research record development and maintenance; study drug accountability; specimen collection, processing and shipment. The incumbent ensures compliance of the research program and its studies with all applicable federal and state regulations, as well as Dignity Health policy.   This positon is responsible for maintaining quality standards for responsive service and professional documentation in compliance with Dignity Health policies and procedures, and federal and state laws and regulations, all which is consistent with the Mission and Values of Dignity Health. This is an exempt position that may require occasional overnight travel and weekend assignments.   Mission: Dignity Health and Sponsoring congregations are committed to furthering the healing ministry of Jesus.  Resources are dedicated to: delivering compassionate, high-quality, affordable health services; serving and advocating for our sisters and brothers who are poor and disenfranchised; and collaborating with others in the community to improve the quality of life.  As part of this mission Dignity Health desires to be a national leader in developing comprehensive research programs, infrastructure and resources to further our commitment to the delivery of the highest quality care and services while maintaining business integrity in all aspects of our operations.   Travel: Occasional overnight travel to investigator meetings and to Dignity Health’s operating regions, corporate headquarters, Dignity Health facilities and corporate satellite offices.   Reporting Relationships:  This position reports directly to the Dignity Health Research Institute Market Clinical Research Manager and will have no direct reports.   Job Standards - Mission and Commitment - Conveys an image of dignity and trustworthiness. Respects the rights, privacy and differences of others. Demonstrates advocacy for vulnerable patient populations. Connects with resources available to assist the poor and vulnerable to provide patient care. Supports the rights of patients in the daily delivery of care. Uses time effectively. Utilizes supplies appropriately and participates in recycle and re-use programs. Follows safety policies for self and patients  - Teamwork and Collaboration - Listens to others ideas, with willingness to be influenced 2) Functions well in teams 3) Gives common goals priority over individual goals 4) Relates with others in a positive manner so that maximum job results are produced. 5) Effectively uses verbal and legible written communication skills with others. This includes being able to read, write, speak and understand English.  - Customer / Patient Focus - Performs in a manner that enhances customer service 2) Demonstrates the attitude that quality can always be improved 3) Explores alternatives for doing things better.  - Standards of Conduct - Maintains patient privacy and confidentiality 2) Consistently follows regulatory, The Joint Commission, and hospital policy requirements relating to the release or access of protected health information 3) Performs duties in compliance with applicable hospital and HR policies and procedures, such as dress code and time and attendance  - Compliance Program - Demonstrates adherence to the Standards of Conduct 2) Independently maintains required tests, licenses, certifications, competencies, employee health (TB screening, fit testing, etc.) and other job-related qualifications 3) Fulfills compliance educational requirements as directed by the Compliance Department or department management  - Environment of Care - Maintains and adheres to Hospital policy and procedures as it relates to: 1) General safety 2) Fire safety 3) Hazardous materials 4) Patient safety 5) Infection control 6) Security management 7) Emergency preparedness 8) Equipment management 9) Utility systems and radiation safety Performance Standards: Incumbents in this position shall comply with all applicable laws and rules including the Dignity Health Standards of Conduct and Dignity Health policies and procedures that apply to his/her job responsibilities, seek guidance when in doubt, promptly report any potential or suspected violation of Dignity Health Standards of Conduct, Dignity Health policy or procedure or applicable laws/regulations and when requested, assist Dignity Health personnel in investigating all allegations of violation. When called upon, the incumbent shall assist in risk evaluation and work collaboratively with facility/entity leaders to implement, monitor and mitigate risk corrective pans outlined by the Compliance program.   Performance Expectations: - Take responsibility for his/her own actions. - Know and comply with applicable laws and rules, including applicable Federal health care program requirements, the Dignity Health Standard of Conducts and Dignity Health policies and procedures as they apply to his/her particular job responsibilities - Seek guidance as provided in the Dignity Health Standard of Conduct and/or policies when in doubt about his/her responsibilities - Refrain from involvement in illegal, unethical or otherwise improper acts - Promptly report any potential or suspected violation of Dignity Health Standard of Conduct, Dignity Health policy or applicable laws or regulations - As requested, assist Dignity Health personnel and authorized outside personnel in investigating all allegations of violations - Meet training requirements within designated timelines assigned - Understand and accept consequences for failure to comply with Dignity Health Standards of Conduct
Job ID
2021-149700
Department
Dignity Health Research Institute Administration
Shift
Day
Facility / Process Level : Name
Corporate Service Center
Employment Type
Full Time
Location
CA-Merced
Clinical Research Coordinator    Job Summary: The Clinical Research Coordinator (CRC) works with the Dignity Health Research Institute Market Clinical Research Manager (MCRM), Principal Investigators, co- and sub-investigators, clinical and ancillary departments, IRBs, and industry or government sponsors of research to plan, coordinate, implement and complete clinical trials and other research projects managed by the Dignity Health Research Institute. The incumbent independently manages all aspects of multiple clinical trials or other research projects as assigned, including but not limited to: research participant recruitment, screening and enrollment; completion of protocol required visits and procedures; collection and reporting of data; coordination of and participation in sponsor monitoring visits or federal audits; query resolution; adverse event reporting, source documentation and research record development and maintenance; study drug accountability; specimen collection, processing and shipment. The incumbent ensures compliance of the research program and its studies with all applicable federal and state regulations, as well as Dignity Health policy. This positon is responsible for maintaining quality standards for responsive service and professional documentation in compliance with Dignity Health policies and procedures, and federal and state laws and regulations, all which is consistent with the Mission and Values of Dignity Health. This is an exempt position that may require occasional overnight travel and weekend assignments.   Mission: Dignity Health and Sponsoring congregations are committed to furthering the healing ministry of Jesus.  Resources are dedicated to: delivering compassionate, high-quality, affordable health services; serving and advocating for our sisters and brothers who are poor and disenfranchised; and collaborating with others in the community to improve the quality of life.  As part of this mission Dignity Health desires to be a national leader in developing comprehensive research programs, infrastructure and resources to further our commitment to the delivery of the highest quality care and services while maintaining business integrity in all aspects of our operations.   Travel: Occasional overnight travel to investigator meetings and to Dignity Health’s operating regions, corporate headquarters, Dignity Health facilities and corporate satellite offices.   Reporting Relationships:  This position reports directly to the Dignity Health Research Institute Market Clinical Research Manager and will have no direct reports.   Job Standards - Mission and Commitment - Conveys an image of dignity and trustworthiness. Respects the rights, privacy and differences of others. Demonstrates advocacy for vulnerable patient populations. Connects with resources available to assist the poor and vulnerable to provide patient care. Supports the rights of patients in the daily delivery of care. Uses time effectively. Utilizes supplies appropriately and participates in recycle and re-use programs. Follows safety policies for self and patients  - Teamwork and Collaboration - Listens to others ideas, with willingness to be influenced 2) Functions well in teams 3) Gives common goals priority over individual goals 4) Relates with others in a positive manner so that maximum job results are produced. 5) Effectively uses verbal and legible written communication skills with others. This includes being able to read, write, speak and understand English.  - Customer / Patient Focus - Performs in a manner that enhances customer service 2) Demonstrates the attitude that quality can always be improved 3) Explores alternatives for doing things better.  - Standards of Conduct - Maintains patient privacy and confidentiality 2) Consistently follows regulatory, The Joint Commission, and hospital policy requirements relating to the release or access of protected health information 3) Performs duties in compliance with applicable hospital and HR policies and procedures, such as dress code and time and attendance  - Compliance Program - Demonstrates adherence to the Standards of Conduct 2) Independently maintains required tests, licenses, certifications, competencies, employee health (TB screening, fit testing, etc.) and other job-related qualifications 3) Fulfills compliance educational requirements as directed by the Compliance Department or department management  - Environment of Care - Maintains and adheres to Hospital policy and procedures as it relates to: 1) General safety 2) Fire safety 3) Hazardous materials 4) Patient safety 5) Infection control 6) Security management 7) Emergency preparedness 8) Equipment management 9) Utility systems and radiation safety Performance Standards: Incumbents in this position shall comply with all applicable laws and rules including the Dignity Health Standards of Conduct and Dignity Health policies and procedures that apply to his/her job responsibilities, seek guidance when in doubt, promptly report any potential or suspected violation of Dignity Health Standards of Conduct, Dignity Health policy or procedure or applicable laws/regulations and when requested, assist Dignity Health personnel in investigating all allegations of violation. When called upon, the incumbent shall assist in risk evaluation and work collaboratively with facility/entity leaders to implement, monitor and mitigate risk corrective pans outlined by the Compliance program.   Performance Expectations: - Take responsibility for his/her own actions. - Know and comply with applicable laws and rules, including applicable Federal health care program requirements, the Dignity Health Standard of Conducts and Dignity Health policies and procedures as they apply to his/her particular job responsibilities - Seek guidance as provided in the Dignity Health Standard of Conduct and/or policies when in doubt about his/her responsibilities - Refrain from involvement in illegal, unethical or otherwise improper acts - Promptly report any potential or suspected violation of Dignity Health Standard of Conduct, Dignity Health policy or applicable laws or regulations - As requested, assist Dignity Health personnel and authorized outside personnel in investigating all allegations of violations - Meet training requirements within designated timelines assigned - Understand and accept consequences for failure to comply with Dignity Health Standards of Conduct ~LI-DH tb32520
Job ID
2020-124962
Department
Dignity Health Research Institute Administration
Shift
Day
Facility / Process Level : Name
Corporate Service Center
Employment Type
Full Time
Location
CA-OXNARD
Division Manager Clinical Research (must be onsite in Lexington, KY as well as travel to London, KY). (Hospital based) - Serve as a central point of contact for and liaison to the research community to provide guidance related to the initiation and ongoing conduct of all clinical research. - Generate local support for research activities, including maintaining visibility with local leaders, physicians and other clinicians, and patients regarding research opportunities and portfolio. - Accountable for all site research activities including adherence to GCP guidelines, site timelines, quality control and assurance of clinical trial data collection, clinical trial drug/device management, and research staff training and development. - Monitor site staff productivity, clinical trial enrollment and assignment of personnel resources to all research including new clinical trial activities.   - Work with the study team and CSHRI Leadership to determine best practices for clinical research operations and study budget accuracy. - Accountable to ensure timely data entry and tracking for both study and site information via the Clinical Trial Management System (CTMS) and other research tracking technology. - Recommend policies, procedures and processes that promote efficiencies and drive quality assurance. - Ensure research site compliance with relevant federal, state, and local regulations as well as CSHRI institutional policies and procedures. - Manage site staff resource allocation within budgeted targets. - Manage and oversee research site staff, including: - Participation in staff interviews and selection processes - Responsible for orientation, training, and development of research staff. - Conducts initial competency assessment of research staff within 90 days of hire, transfer or promotion. - Provide ongoing communications (progress reports) regarding operations and site developments. - Contribute to projects that support the research site and CommonSpirit Research Institute organizational goals. - Promote a culture of individual accountability for quality assurance and improvement within the CRDM function and site research staff.   - Function as content expert in developing appropriate training/educational materials along with the CSHRI Research Integrity function for all site teams.   - Maintain high quality control standards as determined by CSHRI Senior Leadership, annual monitoring plans, and internal audit and monitoring functions.   Hold clinical site staff accountable for all internal and external research base audits and sponsor (federal and industry) monitoring visits; participates as necessary in audits and monitoring visits; review and/or prepare appropriate responses to audit reports; implement corrective actions. - Develop, implement and evaluate performance standards and measurements to support research coordinator and investigator compliance with protocol, GCP, FDA and other research regulatory requirements. - Support and promote: - Standardization of division clinical research operations. - Centralization of core research support services. - Clinical service line based research programs including Cardiology (Interventional Cardiology, Cardiac Surgery, and Electrophysiology), Oncology, Neurology, and other specialties. - Seek opportunities to collaborate with other CommonSpirit Health research facilities and sites to expand research program collaborations. - Meet all mandatory requirements of the position including mandatory training, classes, licensure/certification, employee health requirements, and adherence to CommonSpirit Health's Code of Conduct. - Participate in CSHRI clinical operations oversight and strategic planning activities as directed by CSHRI senior leadership. - Act as liaison between all members of the CSHRI community, including facility research leadership, CommonSpirit Health administrators, physicians/ Investigators, site research personnel , CommonSpirit Health Legal, CommonSpirit Health Corporate Responsibility, and CommonSpirit Health IRB, as well as between CSHRI and industry and government sponsors of research, and government agencies including the U.S. Food and Drug Administration (FDA). (Collaboration) - Other duties as assigned. #LI-DH #missioncritical
Job ID
2021-160070
Department
Research - Other
Shift
Day
Facility / Process Level : Name
CHI National Office
Employment Type
Full Time
Location
KY-LEXINGTON
Job Summary / Purpose The Research Data Scientist (Statistical/Health Data Analytics) is a senior member of the team responsible for developing and managing data/databases and is engaged in the Clinical Analytics work efforts that support Clinical Quality, Patient Safety and Outcomes across the organization. This work requires technical skills that include: a) data mining of large data sets using Structured Query Language (SQL), using R, SAS and/or SPSS statistical analysis programs and/or using other programming languages including Visual Basic and Python, b) designing and implementing custom databases using Microsoft Access and/or Microsoft SQL Server, c) using statistical methods to assess significance of results and to identify/predict outcomes using regression methods, and d) using data visualization tools including pivot tables and charts in Excel.    The Research Data Scientist possesses operational knowledge of clinical/hospital systems and applications, including Electronic Health Record (EHR) systems. The Research Data Scientist has expertise in technical problem / needs analysis and solution development. The Research Data Scientist works with management and staff to define problems, devise solutions, perform work flow analysis, quality control and problem and change management. The position analyzes, reports, presents and encourages the use of data to monitor and improve care and for designing related processes and systems. The Research Data Scientist supports advanced clinical quality inquiry leading to ad hoc report generation and further investigative analysis, often leading to new clinically relevant information used to improve quality, safety, service and growth. The position facilitates the establishment of a data driven culture in the clinical quality and operational areas. The position analyzes, reports, presents and encourages the use of data to monitor and improve care. The position facilitates the establishment of a data driven culture in the clinical quality and operational areas. Essential Key Job Responsibilities - Ad Hoc Reporting - Responsible for collecting, tracking and reporting quality measures / indicators. Produces reports that are timely and accurate. Seeks opportunities to automate or otherwise improve the accuracy and efficiency of data collection and reporting. - Is able to pull and integrate data form disparate sources. - Produce ad hoc data and reports. - Perform data scrubbing, trouble-shooting, quality checking, and usability analysis to identify anomalies, which need to be addressed prior to delivery of analytic results. - Develop and produce on a regular basis standard to moderately advanced reports pertaining to clinical quality and safety performance. - Collaborate with various stakeholders within the organization, to design and construct clinical quality and safety performance measures and electronic databases for custom recurrent and one-time data collection efforts. - Uses Structured Query Language and/or other programming languages or software to query large data sets. - Provide project leadership and ongoing support of multiple clinical systems - Understand hospital cost accounting and reimbursement methods; familiarity with diagnosis and procedure coding systems. - Provide collection and distribution of data and other documents to meet regulatory and system benchmarking requirements - Provide data aggregation for indicators for quality management, patient safety, and infection prevention used to evaluate and monitor practice - Analysis and Performance Improvement - Uses computer software to analyze clinical and financial data to help identify and understand opportunities to improve outcomes, reduce costs, and improve satisfaction with clinical care. Leads or participates as a member of cross functional teams created to improve processes - Can delve into data to discover discrepancies and patterns. - Can build models and analyze data to unearth trends and patterns. - Identify opportunities related to costs, utilization, and quality with the ability to report findings to senior leadership. - Perform project support, data analysis and synthesis of clinical and administrative data from multiple sources into meaningful summary reports and presentations - Provide structured analyses of operations to help determine specific opportunities for clinical performance improvements - Attend multi-disciplinary team meetings and review data for opportunities for improvement - Partner with operational leaders, department directors and improvement teams. Able to identify major trends from data, prepare graphs and measurement tools and report variances in data - Maintain data metrics and provide reports and summaries for committees, meetings and other administrative or medical staff needs - Analyze, report, present, and encourage the use of data to monitor and improve patient care and for designing/improving related patient care processes and systems. - Prepare comparative analysis by accurately aggregating and summarizing data in statistical and or graphical formats for review by medical staff and clinical management - Statistical Analysis - Ensures statistical validity and accuracy of analyses and reports. Tests for relationships and significance, determine whether variations may be due to normal random variation or to an assignable cause. - Demonstrate and apply basic understanding of data collection strategies, data display methods, basic statistical process and performance improvement concepts and principles - Applies statistical methods to asses significance of results - Ensure that data and statistics can be interpreted; resulting in usable information for Quality Improvement teams to drive improvements. - Work with statistical data to create advanced charts, tables, and graphs. - Apply statistical process control techniques and advanced statistical methods. - Apply regression methods to identify and predict outcomes. - Data Mining and Reporting - Applies data modeling and SQL methods to assimilate data from various sources and develop useful reports of clinical, financial, and quality measure results. - Participate in data processes to improve accuracy, efficiency, and productivity of data entry and reporting. - Identify major trends in data collection; prepare graphs and report variances in data to leadership - Coordinate, prepare, and distribute statistical reports reflecting departmental and service line activities - Prepare comparative analysis of data and compile meaningful operational reports - Perform data modeling and SQL querying and reporting methods. Write database queries, - Will explore opportunities for using Big Data technologies for mining structured and unstructured data. - Establish process for coordinating, preparing and distributing statistical reports - Education and Consultation - Educates and works with organizational leaders to ensure that analyses are used appropriately and effectively. Serves as a resource to others on the definition of and reporting of external quality measures, acts as an internal consultant on complex statistical and or computer techniques as well as data related issues. - Provide tools to present data as information and in the format to make fact based decisions - Serve as an internal consultant on statistical analysis. - Attend clinical management and medical staff meetings to provide data and assistance in interpreting performance improvement and/or outcomes data - Technical Database Management and Information Systems - Provide technical management of uploading data, transmitting data files, investigating error reports and correcting data for submission. - Design and implement databases using Microsoft Access and/or Microsoft SQL Server. - Demonstrate ability to merge clinical and financial data - Assist in designing and coordinating the utilization of integrated information system databases and maintaining reports and statistical compilations for data collected - Develop and maintain databases and systems for automating, measuring, monitoring and tracking organizational performance changes. - Develop comprehensive solutions that require both clinical and technical expertise. - Develop and execute system testing scenarios. Operational knowledge of non-clinical departments / systems and interactions between clinical and non-clinical systems. - Work with many stakeholders to obtain data; work with Information Technology in creating reports and additions of fields for purposes of tracking and reporting data. - Manage data issues, including reviewing, compiling, testing and communicating database upgrades - Complies with Hospital/Department policies. - Demonstrates professional responsibility as per job classification. - Demonstrates Core Values Based on Behavioral Standards. - Demonstrates positive guest relations skills in all dealings with hospital visitors and vendors. Serves as a liaison between the Clinical Analytics Department and both our internal and external customers including: hospital staff, managers, directors, senior executives, physicians, vendors and other corporate affiliations. - Demonstrates a positive outlook toward job change. Is willing to adapt to the changing needs of the organization. - Other duties as assigned by management.
Job ID
2021-181751
Department
Research Department
Shift
Day
Facility / Process Level : Name
CHI Saint Joseph Health System
Employment Type
Full Time
Location
KY-LEXINGTON
This position is open to a remote worker, and responsible for supporting CommonSpirit Health’s Research Institute (CSHRI) programs across the system. This position provides program administrative leadership and management support with independent guidance to ensure the successful implementation of multiple moderate to large projects of high complexity and visibility.   This position manages and facilitates system level initiatives and projects, collaboratives, and workgroups while working directly with the CSHRI leaders, sponsors, and other key stakeholders. This position is focused on achieving the program’s objectives, assessing operational, financial and compliance risk, and overseeing quality timelines throughout the lifecycle of the program. This includes ensuring successful outcomes of programmatic and financial requirements, milestones and deliverables, enhancing operational management and efficiencies and increasing operational performance. This position provides leadership and decision-making ability in circumstances where competing interests and priorities involve the highest levels of CSHRI management and escalates to CSHRI and /or MBO leadership as needed.   This position must be able to coordinate the efforts of team members at multiple Research Centers in locations across the country as well as with CSHRI functional team members. This position will collaborate with the CSHRI leaders to define the program’s objectives and oversee quality timelines throughout its lifecycle, while serving as the central point of contact for the operational management of the program. Collaborates with CSHRI leaders on program reporting requirements and budgets.   ESSENTIAL KEY JOB RESPONSIBILITIES - (30%) Programmatic Leadership Functions - (15%) Clinical Trial/Start-up and Maintenance - (25%) Network Program Management - (10%) Interdepartmental Collaboration - (10%) Implementation of Research Initiatives - (10%) Efficiency and Operational Processes Benefits Include: Benefits include Medical, Dental, Vision, Paid Time Off, Holidays, Retirement Program, Disability Plans, Tuition Reimbursement, Adoption Assistance, Employee Assistance Program (EAP), Discount Programs, Life Insurance Plans, Worker Compensation, Dress for Your Day Policy, Voluntary Benefits.   Colorado Compensation Range: $35.28 to $45.87 hourly rates annualized.   #CHI-LI #LI-Remote #missioncritical ~DH-LI 
Job ID
2021-177098
Department
Research Department
Shift
Day
Facility / Process Level : Name
CHI National Office
Employment Type
Full Time
Location
-Remote Opportunity
Cardiology, Neuro or Stroke Experience preferred.   The Research RN works with research management, principal investigators, co- and sub-investigators, clinical and ancillary departments, IRBs, and industry or government sponsors of research to plan, coordinate, implement and complete clinical trials and other research projects managed by the research team.  The incumbent has responsibility for the oversight of studies that explore complex medical diseases, which involve specialty and subspecialty expertise.  The incumbent serves as clinical nursing knowledge role model in the care of research participants, performing clinical procedures and assessments of research participants that are appropriate within the RN scope of practice.  In conjunction with the PI and other facility/clinic staff, s/he may provide direct patient care related to the research protocol.    - Manage studies with Principal Investigator and research management to develop effective clinical research programs. - Contribute to policy and procedure review and development as delegated by research management. - Implement and monitor clinical trials and research projects that meet institutional and facility/clinic objectives, and ensure compliance with protocol and sponsor requirements and all aspects of U.S. Food and Drug Administration (FDA) and Office of Human Research Protections (OHRP) regulations, as well as institutional requirements. - Support research management, PI, sponsors/CROs in identifying and evaluating potential new trials for feasibility of implementation at the site, provide recommendations. Complete feasibility assessments as needed. - Prepare, manage, submit all required study/regulatory, documents, applications and forms, including but not limited to the applicable Institutional Review Board (IRB) applications form(s), informed consent documents, 1572, conflict of interest forms and other forms as required by the sponsor, IRB, or institution.   - Attend and prepare materials for clinical department meetings, as needed, for presentation of new protocols for review. - Coordinate and participate in site initiation and other sponsor-required training for all protocols. - Determine effective strategies for promoting/recruiting research participants and retaining participants in long term clinical trials. Actively recruit, screen and enroll participants in trials. 
Job ID
2021-176660
Department
Research - Cardiovascular
Shift
Day
Facility / Process Level : Name
CHI Health
Employment Type
Full Time
Location
NE-OMAHA
The Senior Clinical Research Coordinator participates in the comprehensive administration of clinical process from study start up through study closure and is a central liaison to the investigator, the research subject, the hospital/clinic and the industry or government sponsor. Additionally the Senior Clinical Research Coordinator provides oversight and leadership for clinical trial activities and staff at the research site.  The Senior Clinical Research Coordinator oversees and ensures that all clinical trial activity is in accordance with Good Clinical Practice (GCP), departmental Standard Operating Procedures (SOP) and procedures outlined in the research protocol.  The Senior Clinical Research Coordinator will serve as a mentor and oversee training for the other research staff.  Clinical responsibilities include/involve patient recruitment and follow up, as well as research related patient care per scope of practice during the course of the enrollment.  This position works closely with essential research constituencies (e.g. PIs, research coordinators, and other internal and external research-related parties as needed) to ensure strategic direction, ongoing administrative management and support of clinical research trials. The Senior Clinical Research Coordinator maintains a matrix relationship with the designated MBO research administrative contact. The Senior Clinical Research Coordinator is able to adapt and change focus from task to task depending on the immediate needs of the research department.   - Proficient to handle responsibilities assigned to a Research Coordinator II. - Chairs and/or participates in councils and/or committees as needed. - Collaborates with the Clinical Providers to uphold research requirements for designated facilities. - Assists with the clinical assessment and evaluation, preparation of abstracts and data collection and analysis for publication, presentation and professional meetings. - Recruits clinical research studies based on need and criteria defined by the research department.  - Recommends policies, procedures and processes that promote efficiencies and drive quality assurance. - Provides ongoing communications (progress reports) to the regarding research operations and site developments.  
Job ID
2021-156941
Department
Research Department
Shift
Day
Facility / Process Level : Name
CHI Health
Employment Type
Full Time
Location
NE-OMAHA
Job Summary / Purpose: The position of leader, Intellectual Property and Life Sciences Innovation will closely work with executive leadership, including senior executives in the Intellectual Property (IP), and Strategic Innovation group to (1) work across the organization to educate inventors about IP development and commercialization, lead the patenting process, and drive IP commercialization processes and generate interest and engagement in healthcare innovation across the organization, and (2) Coordinate and lead key components of life sciences innovation process: opportunity identification, launch plan development, operational integration, measurement & evaluation, and potential investment support.   Essential Key Job Responsibilities: - Invention Management: Leader will assess, or supervise the assessment and evaluation of, disclosed inventions for merits and completion, and meet with the inventor(s) to initiate CommonSpirit Health’s IP management process. Where appropriate, Leader will select and work with external patent and/or copyright counsel to manage such process and will make decisions on the filing, prosecution, maintenance and termination of CommonSpirit Health’s intellectual property portfolio continuously evaluating the cost/benefit relationship of inventions. - Strategic Planning: Assists in the development of CommonSpirit Health policies and procedures for IP management and formulation of the strategic focus of the IP office. - Education: Educates and advises CommonSpirit Health stakeholders (e.g., employees, management, independent medical staff and any others) as necessary on institutional policies pertaining to IP, conflicts of interest, publication, consulting, confidentiality, equity and CommonSpirit Health’s intellectual property process. - Manage CommonSpirit Health’s IP portfolio and leverage such IP to negotiate equitable licenses with suitable partners. - Marketing: Will create a team or a process to evaluate, manage and supervise the marketing and commercialization of a CommonSpirit Health-wide portfolio of IP, continuously evaluating the cost/benefit of invention maintenance. - Other duties, as necessary, including resolving issues relating to conflicts of interest or conflict of contractual obligations or other policy matters, directing, supervising and managing the efforts of IP professionals and consultants and providing professional guidance as required. - Identifies and evaluates potential life sciences entrepreneurial organizations and large industry partners that have the ability to benefit the mission of CommonSpirit. - Conducts due diligence on the capabilities of partners, in concert with identifying client needs, and evaluates opportunities for trial, adoption, and/or investment Maintains database on and relationships with a robust network of incubators, entrepreneurs, venture organizations and other key stakeholders to consistently position CommonSpirit as an early introduction point for life sciences companies. - Negotiates, delivers and operationalizes innovative life sciences partnerships that supports CommonSpirit Health’s strategy. - Directs life sciences projects by developing and ensuring adherence to milestones/deadlines, and alignment between internal stakeholders. Engages CommonSpirit system leadership, from executives to facilities to vet and validate opportunity areas – liaison between CommonSpirit Health and external life sciences innovation partners.   The job summary and responsibilities listed above are designed to indicate the general nature of the work performed within this job. They are not designed to contain or be interpreted as a comprehensive inventory of all job responsibilities required of employees assigned to this job. Employees may be required to perform other duties as assigned.   #LI-Remote #missioncritical #LI-DH
Job ID
2021-181838
Department
Intellectual Innovation Network
Shift
Day
Facility / Process Level : Name
Dignity Health System Office
Employment Type
Full Time
Location
AZ-Phoenix
Responsible for administration, oversight, management, implementation, and accountability of clinical research, data collection activities and clinical operations for Trauma research program. Coordinates project activities and regulatory approvals. Essential Key Job Responsibilities - Facilitates research activities in partnership with the Trauma Medical Director and Research Administration colleagues leveraging clinical experiences in related specialty area. Is familiar with resources available in the institution and locally. - Completes grant, journal, and publication writing duties and responsibilities as assigned. Maintain standards of publication and authorship. - Serves as the primary liaison for internal and external project sponsors, routinely informing key stakeholders of project plans, status updates, milestones (including subject enrollment metrics, timely data collection and submission and related contracted and/or grant goals) through regular reporting and coordinated discussions.  - Promotes and adheres to responsible conduct of research (scientific ethics) policies. Maintain a professional attitude with patients, visitors and other hospital personnel while assuring confidentiality of patient information and other hospital information. - Conceive, plan and conduct research for trauma-related grant opportunities and funding using advanced search techniques.  Possess proficiency in searching funding sources through on-line databases and printed resource material.   - Assist the members of the Division of Trauma Surgery and Surgical Critical Care in the development of documents and proposals in response to Requests for Proposals from private foundations and governmental funding sources. Includes preparation of the RFP. - Provides methodological approaches appropriate to the problem to be addressed. Develops well-defined objectives and thinks things through. Completes projects efficiently and accurately.  - Meets target delivery dates in studies and especially in collaborative ventures.  - Has a strong working knowledge of GCP, ICH, DHHS, OIG and FDA regulations and depth of clinical expertise in the assigned area is required along with familiarity of all applicable federal and state regulations and institutional policies. Coordinates the process flow of a study from initial concept to IRB through the final study closure. Facilitates feasibility reviews based upon governing policies.  - Support and guide trauma related projects through the Creighton or outside IRB approval process from drafting of the IRB proposal in conjunction with study principle investigator to respond to queries in order to gain IRB approval as soon as possible.  - Evaluates external and internal databases for potential use in Trauma related studies and when necessary, combines available databases to facilitate Trauma related studies.  - Actively manages Trauma related multi-center studies in order to adhere to study requirements and coordinates participation with sponsoring organizations.  - Supports all Trauma related scientific study abstract and manuscript development and submission process, maintaining communication with scientific journals.   - Supports all Trauma related scientific presentation submissions meeting appropriate submission deadlines.   
Job ID
2021-166252
Department
Research Department
Shift
Day
Facility / Process Level : Name
CHI Health
Employment Type
Full Time
Location
NE-OMAHA

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