WE DO NOT OFFER RELOCATION ASSISTANCE OR REMOTE WORK. PLEASE DO NOT APPLY IF YOUR ONLY RESEARCH EXPERIENCE IS LABORATORY-RELATED.
The Clinical Research Coordinator (CRC) is responsible for the coordination and administration of clinical trials under the direction of the Clinical Research Manager, the Principal Investigator, and the Medical Director. The CRC will develop, implement, and coordinate research and administrative procedures for the successful management of clinical trials. The CRC will perform diverse administrative duties requiring analysis, sound judgment, and a high level of knowledge of study-specific protocols.
DUTIES AND RESPONSIBILITIES
- Administratively and clinically manage an average of six to eight clinical trials
- Adhere to Research SOPs
- Adhere to Good Clinical Practices and the study protocols
- Ensure scientific integrity of data and protect the rights, safety, and well-being of patients enrolled in clinical trials
- Discuss study protocols with patients and verify the informed consent documentation
- Provide patient with written communication of their participation (i.e. copy of the signed informed consent)
- Ensure patient’s referring physician receives notification of patient’s participation in studies as requested by the patient
- Meet with patient for each visit and maintain accessibility to discuss any questions/concerns regarding the study
- Dispense study medication in a professional and accountable manner following protocol requirements
- Collect, process, and ship blood/urine specimens at scheduled patient visits
- Perform ECGs and obtain vital signs of patients
- Schedule all patient research visits and procedures consistent with protocol requirements
- Complete and maintain case report forms per FDA guidelines, and review them against the patient’s medical record for completeness and accuracy
- Administer questionnaires/diaries per protocol
- Ensure that non-serious and serious adverse events are properly documented and reported
- Screen all laboratory results when received and follow protocol procedure regarding abnormal results
- Ensure all laboratory results are given to appropriate doctors for review of clinical significance, then file results in the patient study binder
- Submit patient reimbursement requests at the conclusion of patient’s participation in the protocol
- Ensure the filing and maintenance of all regulatory documents
- Schedule monitor visits and set up for monitoring visits prior to monitor’s arrival
- Other duties as assigned
Job Type: Full-time
Pay: $52,000.00 - $72,800.00 per year
Benefits:
- Dental insurance
- Health insurance
- Paid time off
- Parental leave
- Vision insurance
Education:
Experience:
- clinical (NOT IN A LABORATORY) research site managment: 5 years (Required)
Language:
License/Certification:
- CCRC/CCRP certification from SOCRA or ACRP? (Required)
Work Location: In person
