Job Description
Job Description
Salary : $65,000-$85,000 Annual
Lead Clinical Research Coordinator
The Company
Are you an ambitious and proactive individual seeking an exciting opportunity in clinical research? Join Axsendo Clinical Research, a rapidly growing network of clinical research sites specializing in Neurology, Cardiology, Metabolic Disease, Vaccines and Medical Devices.
We are eager to welcome a dedicated Lead Clinical Research Coordinator to contribute to our dynamic and busy team!
The Role
Protocol Understanding :
- Read and comprehend assigned research protocols.
- Conduct prescreening of potential patients.
Site Staff Training :
- Train site staff on the study's purpose.
- Record attendance during training sessions.
Enrollment Management :
- Use the Electronic Medical Record (EMR) to screen eligible patients.
- Facilitate patient qualification discussions with the Principal Investigator.
- Report Adverse and Serious Adverse Events to IRB and Sponsor following guidelines.
- Obtain and document informed consent following ICH / GCP and site SOPs.
- Ensure timely and accurate data entry based on the ALCOA principle.
Monitoring Visit Preparation :
- Organize and collect all source data in the electronic source system.
- Resolve outstanding items from previous monitoring visits.
- Address and close any queries from prior visits.
- Keep temperature and accountability logs readily available.
Ongoing Study Oversight :
- Plan subject visits as per protocol-specific schedules.
- Prevent protocol deviations related to out-of-window procedures.
- Coordinate with location administration to ensure space and resource availability.
- Dispense / collect study medication with accurate Investigational Product accountability.
- Collect and process subject laboratory specimens following protocol.
- Complete case report forms (CRFs) and other patient tracking information accurately and promptly.
- Maintain a comprehensive understanding of all data collection instruments and ensure accurate data collection according to the protocol.
Qualifications
- Bachelor’s degree in nursing, Allied Health, or Life Sciences
- 2+ years of clinical research coordinator experience is required.
- Previous electronic CTMS experience preferred!
Highlights
- $65,000-$85,000 Annual Salary
- Great company culture and tons of room for growth!
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