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. Candidates must reside within the United States. Expect 8-10 days on-site 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 on 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 other duties as assigned.
• Responsible for all aspects of site management as prescribed in the project plans.
• General on-site monitoring.
• Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.
• Ensure the protection of 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 document review; 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.

We value a work environment that is fast paced, adaptable to changing priorities, teamwork-oriented, and technology-based. We collect data directly into an electronic environment.

• 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 movement with ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Light to moderate lifting and carrying of objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Regular and consistent attendance.
• Varied hours may be required.

Target Pay Range: $100-115K based on job title.

Remote.

Applications will be accepted on an ongoing basis.

Learn more about our EEO & Accommodations request here.