Job description
This is an integral position on our team. Successful candidate will handle multiple protocols, planning and coordinating patient participation in a drug trial. Regular status updates for the rest of the team is critical. In addition the Study Coordinator will assist in the maintenance of all study related Case Report Forms (paper or electronic) and will understand the ethical issues involved in human subject research, adhering to the Federal Regulations governing research.
Some of the Study Coordinator responsibilities include,
- Will have regular communication with each CRA (Clinical Research Assistant) involved with assigned protocols.
- Monitor the overall day-to-day conduct of assigned studies in accordance with the specified protocol requirements, Standard Operating Procedures, and Good Clinical Practice to ensure integrity regarding all aspects of the study.
- Reviews forms created or revised for assigned trials to assure protocol compliance.
- Maintains files using standardized study document labeling and filing procedures.
- Implement initial protocol and amendments, train staff who will be involved in patient treatment and management.
- Maintains an up to date contact list.
- Assists with patient screening and determination of eligibility.
- Facilitates the informed consent process ensuring that consent is appropriately completed.
- Prepares and manages source documents according to standard operating procedures.
- Recognize deviations to the protocol and work with management and staff to address corrective actions.
- Will assist CRA with case report form completion and query resolution.
- Will work with the Principal Investigator to complete and submit Serious Adverse Event reports.
- Closeout related activities in conjunction with the CRA.
- Will provide documentation for all deviations whether related to the protocol or SOP.
- Ensure that all team members involved understand and adhere to assigned protocols.
- Bachelors degree - preferred, in life sciences. Additional demonstration of clinical research knowledge as evidenced by the use of either CCRP or CCRC credentials is highly desirable.
- Knowledge and training in general office administration skills, including computer applications, filing systems, etc. Familiarity with medical terminology desirable.
- Demonstrated ability to accurately and efficiently complete assignments in Clinical Investigations and demonstrated capability to perform the data review and CRF completion in its entirety with minimal direction.
- Prior experience in clinical trials coordination.
- Ability to communicate ideas in a non-confrontational manner to multiple audiences and forums.
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