FSP - Clinical Research Associate - CRA​/Sr. CRA - Northeast or - Oncology

Job Description

Our FSP team is currently seeking Unblinded CRAs with 1-3 years of monitoring experience. Candidates must reside within the United States. The role requires 8–10 days onsite per month, with a mix of onsite and remote work. 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.

• Responsible for 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.
• Liaise with vendors and perform other duties as assigned.
• Responsible for all aspects of site management as prescribed in the project plans.
• General on‑site monitoring: ensure study staff have received proper materials and instructions to safely enter patients into the study.
• Protect study patients by verifying that informed consent procedures and protocol requirements are adhered to according to applicable regulatory requirements.
• Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source documentation.
• Monitor data for missing or implausible data.
• Responsible for all aspects of 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) and 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.
• Comfortable working in an environment that is fast‑paced, with changing priorities and technology‑based data entry.

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

• Ability to sit for extended periods and operate a vehicle safely.
• Repetitive hand movements with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Occasional crouching, stooping, frequent bending and twisting of upper body and neck.
• Ability to access and use a variety of computer software, both in-house and off‑the‑shelf.
• Light to moderate lifting and carrying (or otherwise moving) objects including luggage and laptop computer with a maximum lift of 15–20 lbs.
• Regular and consistent attendance; varied hours may be required.

$100,000–115,000 based on job title.

Learn more about our EEO & Accommodations request here.