Experienced CRA or - Unblinded - West East - FSP

Job Summary

Our FSP team is currently seeking Unblinded CRAs with 1‑3 years of monitoring. Candidates must reside within the United States. The role requires 8‑10 days on site per month, a mix of onsite and remote, open to West Coast, Central, and East Coast major hub locations.

You will utilize your skills, knowledge, and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards.

• All aspects of study site monitoring, including routine monitoring and close‑out of clinical sites, maintenance of study files, conduct of pre‑study and initiation visits, liaison with vendors, and other duties as assigned.
• All aspects of site management as prescribed in the project plans.
• General On‑Site Monitoring:
  Ensure study staff receive proper materials and instructions to safely enter patients. Ensure protection of study patients by verifying informed consent procedures and protocol requirements are adhered to per regulatory requirements.
• Ensure data integrity on CRFs or other data collection tools by careful source document review. Monitor data for missing or implausible data.
• Registry management as prescribed in the project plans.
• Undertake feasibility work when requested.
• Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
• Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management.
• Assist with training of new employees (e.g. co‑monitoring).
• Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable); may act as a local client contact as assigned.
• Perform other duties as assigned by management.

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure).
• 1+ years of clinical monitoring experience.
• 50‑60% overnight travel.

Work performed in an office environment with exposure to electrical office equipment, frequent travel to client/site locations with occasional domestic and international travel.

Physical requirements include ability to sit for extended periods, operate a vehicle safely, repetitive hand movements, occasional crouching, stooping, bending, twisting, access to and use of a variety of computer software, light to moderate lifting of up to 15‑20 lbs, regular attendance, and varied hours may be required.

Target pay range: $100‑115K based on job title.

Remote applications will be accepted on an ongoing basis.