Clinical Research Coordinator

Job Description

Responsibilities and Duties

Under direct supervision of Principal Investigator and Team Leader of Research and recruitment/Lead Clinical Research Coordinator, the Clinical Research Coordinator will

- Complete training requirements such as IATA/HAZMAT, sponsor specific training modules, GCP and eCRF training courses.

- Conduct/monitor the screening and recruitment of subjects for research trials using knowledge of current protocols and inclusion/exclusion criteria to determine subject eligibility.

- Explain informed consent specific to protocol to potential enrollees, answers questions if any, and documents the informed consent process.

- Educate subjects on protocol related procedures/assessments in which they must participate as a study subject.

- Collect, organize, and maintain data and test results for source documentation of all research subjects.

- Assist in the management of the study subjects' health status during the course of research care and development of treatment plan related to the research protocol. Conduct any needed assessments using protocols for review by the PI when appropriate.

- Completes visit procedures according to protocol schedule and checks on visit measurements, lab results, concomitant medications and presence of adverse events.

- Draw blood when needed, process and ships specimen according to sponsor requirements including vital signs, EKG and radial augmentation index studies.

- Complete source documents and enters the same in the CRF or eCRF.

- Work closely with sponsor monitors during site initiation visits, site monitoring visits, and answer queries when needed.

- Complete drug accountability records, dispense study medications per protocol requirements or through the IVRS.

- Miscellaneous duties such as keeping records of temperature logs of drugs storage and freezers.

- Complete study close out visit by proper drug accountability and shipment of used and unused study medications.

- Responsible for IRB submissions, SAE reporting, continuing approval reports.

- Maintain Trial Master Files & document according to Regulatory Retention Requirements. - Document all of the above in a timely manner.

- Knowledge, Skills, and Abilities: Work requires the ability to understand and follow oral and written instructions generally acquired through a high school education and medical assistant programming.

- Sources viable subjects and pre-screens candidates to determine a fit for current study needs.

- Conduct chart reviews and contact subjects for screening visits.

- Have knowledge of all the active studies at CRP. - Take in coming calls from Radio Ads and TV ads and schedule prescreening/ screening visits.

- Create prescreening form to complete for when radio ad or TV ad runs to go over study with the subjects.

- On days when no patients are being seen by CRC 10 recruitment calls are expected to be made.

- All recruitment attempts/ calls are to be completed on the communication log and turned into the Lead CRC daily.

- Maintain and organize all study supplies. (putting away lab kits, IP, study binders and any other study supplies.)

Qualifications and Skills

High School Diploma or GED equivalent. Certificate from accredited Medical Assistant Program or higher. Clinical research certification (ACRP, SoCra) is a plus.

Job Type: Full-time