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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
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
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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