What are the responsibilities and job description for the Lead Clinical Research Coordinator position at Axsendo Clinical?
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
- Great company culture and tons of room for growth!
Salary : $55,000 - $70,000
