Clinical Research Coordinator
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The CRC manages all aspects of conducting clinical trials. Required to have an in-depth knowledge of protocol requirements and good clinical practices as set forth by federal regulations. As the primary resource for the protocols, the CRC will act as liaison between the investigators, primary care providers, the Institutional Review Board (IRB), the Office of Clinical Research (OCR), and the sponsor. Along with the investigator, the CRC will screen, enroll and follow study subjects, ensuring protocol compliance and close monitoring while the subjects are on study. In addition, the CRC is responsible for all data and source documentation, adverse event reporting and maintenance of complete regulatory files.
A day in the life of Clinical Research Coordinator at Hackensack Meridian Health includes:
- Follows patient accounting procedures CRC schedules all testing required by the trial protocol.
- Completes clinical research requisitions and works directly with patient registration to identify which testing is study related. Utilizes the V70.7 diagnosis code to identify study related procedures.
- Ensures that patient billing is not generated for procedures covered by the clinical trial protocol
Follows procedures for case report form (CRF) preparation and completion Ensures timely and accurate CRF completion for each study subject.
Keys data for remote data entry or provides completed CRFs on a timely basis.
Reviews keyed data for accuracy. Maintains source documentation for all CRF entries, including clinic chart visit notes, lab data, and procedure reports.
Provides auditors with completed CRFs, medical records, lab data and other source documents for review.
Corrects and edits CRFs as appropriate.
Responsible for the sound conduct of clinical trials within clinical discipline Adheres to the Code of Federal regulations when conducting research.
Ensures that all state and federal standards are followed.
Abides by the Standard Operating Procedures and institutional IRB.
Participates in the internal auditing process and contributes to the Quality Improvement Process.
Complies with Hackensack Meridian Health's Corporate Compliance Department.
Actively participates in ongoing research specific quality assurance activities such as chart audits for protocol compliance.
As needed, serves as a mentor/preceptor to new CRC's. Communicates effectively with staff and outside agencies, and assists in the promotion of teamwork.
Contributes to the Office of Clinical Research spirit de corps.
Attends study investigator meetings as needed.
Maintains accurate and complete documentation IRB submissions are accurate and complete.
Adheres to screening and enrollment procedures.
Reviews and verifies all relevant source documentation in the subject's medical record to confirm study eligibility.
Reviews the protocol, informed consent form, and follow-up procedures with potential study subjects.
Ensures the current approved informed. consent is signed before subjects are screened and enrolled.
Ensures that the randomization procedure is followed as per protocol guidelines.
Meets enrollment targets.
- Processes specimens according to protocol and IATA Guidelines.
- Ensures positive relations with study sponsors.
- Implements subject follow-up procedures.
Education, Knowledge, Skills and Abilities Required:
- Registered nurse with a current license to practice and at least two (2) years of clinical experience; OR
- Baccalaureate in a health-related field and at least four (4) years of clinical research-related experience; OR
- Two (2) years of clinical research-related experience and a Master’s degree in a related field.
If you feel that the above description speaks directly to your strengths and capabilities, then please apply today!
As a courtesy to assist you in your job search, we would like to send your resume to other areas of our Hackensack Meridian Health network who may have current openings that fit your skills and experience.