Clinical Research Coordinator

Requisition ID
2021-156649
Employment Type
Full Time
Department
Research Department
Hours / Pay Period
80
Shift
Day
Standard Hours
M-F 8:00-4:30p
Facility / Process Level : Name
CHI Health
Location
NE-OMAHA

Overview

CommonSpirit Health was formed by the alignment of Catholic Health Initiatives (CHI) and Dignity Health. With more than 700 care sites across the U.S. & from clinics and hospitals to home-based care and virtual care services CommonSpirit is accessible to nearly one out of every four U.S. residents. Our world needs compassion like never before. Our communities need caring and our families need protection. With our combined resources CommonSpirit is committed to building healthy communities advocating for those who are poor and vulnerable and innovating how and where healing can happen both inside our hospitals and out in the community.

Responsibilities

The Clinical Research Coordinator I is responsible for the coordination of assigned clinical research conduct & trials from study start up through study closure by serving and is the initial resource to the investigator, the research subject, the hospital/clinic and the industry or government sponsor related to the research conduct.  The Clinical Research Coordinator I 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.  Clinical responsibilities include patient recruitment and follow up, as well as direct patient care per scope of practice.

Essential Key Job Responsibilities

  1. Thorough coordination of all duties for designated clinical research trials under the direction of the Principal Investigator and management.
  2. Recruitment of eligible research trial subjects.
  3. Obtain informed consents from eligible subjects for clinical research trials.
  4. Administration and monitoring of test article(s) (when applicable).
  5. Reports adverse effects and protocol deviations per reporting guidelines.
  6. Maintains proper documentation per departmental SOPs and GCP guidelines.
  7. Data reporting to sponsor and regulatory agencies per protocol, SOPs, and GCP.
  8. Collection and shipment of required specimens for protocol and IATA guidelines (if applicable).
  9. Completion and submission of regulatory documents to the study sponsor and to the Institutional Review Board (IRB).
  10. Communication and collaboration with study Investigators, team members and management.
  11. Consistently seeks ways to improve efficiencies in the department and organization.
  12. May be required to travel to and attend investigator meetings
  13. Performs other duties as may be assigned by management.
  14. Other duties as assigned by management.

 

Qualifications

B.A. or B.S in Health related field, including course work or relevant experience in anatomy, physiology, medical terminology, medical records, and information management, or an equivalent combination of related education and work experience preferred.

 

Able to maintain licensure in already obtained health related field (example: CNA, LPN, RN, BSN, or Pharmacy PharmD). 

Certification as a Clinical Research Coordinator preferred or willing to sit for exam when eligible: ACRP (CCRC) or SOCRA (CCRP).

 

Valid driver’s license.

Completion of the CORE CIRI Research Education will occur within 30 days of hire.

 

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