Lead Clinical Research Coordinator

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!