Atlantic Research Group is looking to hire a Clinical Data Coordinator to join our growing team. This position is located in Charlottesville, VA. Do you enjoy the thought of playing a major role on the clinical trial management side of an exciting therapeutic study? If so, this opportunity may be for you.
The Clinical Data Coordinator remotely maintains essential study documents for clinical research studies, enters data onto Case Report Forms and ensures study compliance. The below list of duties (listed in order of importance) will give you a view of your day-to-day responsibilities.
- Works in collaboration with other research team members including but not limited to Principal Investigators, Research Nurse Coordinators, Sponsors and project team members.
- Organizes and prepares for all study related sponsor visits including, but not limited to Pre-Site Initiation Visits, Site Initiation Visits, Routine Monitor Visits, Close-Out Visits, Internal Audits, and Sponsor Audits.
- Verifies that all patients have provided informed consent prior to entering study specific data.
- Compares schedule of events to Case Report Form (CRF) in order to correctly capture study specific data points on the CRFs.
- Remotely accesses the clinical data management system, or EDC, and records accurate data by completing CRFs in a timely manner.
- Remotely resolves data queries in the EDC accurately and within study specific timeframes.
- Maintains timely patient follow-up by accurately reviewing the study specific follow-up schedule in the protocol and completes follow-up CRFs.
- Reports, tracks, and files off-site Serious Adverse Events (SAEs) to the governing Institutional Review Board (IRB) within the required time frame dictated by the IRB of record.
- Utilizes the SAE reporting log to track the receipt, submission and acknowledgement of off-site SAEs per protocol.
- Occasional travel as needed for on-site training and/or project needs.
Knowledge, Education, and Skills Required:
The successful candidate will have a Bachelor’s degree in Science (Chemistry, Biology, Nursing) or a minimum of 3 years experience in research that includes case report form completion and research regulatory reporting.
ARG is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. ARG also complies with all work authorization and employment eligibility verification requirements and is an E-Verify employer.