FSP Clinical Research Associate 2 - Central Region

About the Role

We are seeking a CRA 2 in the Central Region with 2 years of monitoring experience. This role involves 8-10 days on site per month, combining both onsite and remote work.

Responsibilities

• Responsible for all aspects of study site monitoring, including routine monitoring and close-out of clinical sites, maintenance of study files, and conduct of pre-study and initiation visits.
• Liaise with vendors and perform other duties as assigned.
• Manage all aspects of site management as prescribed in the project plans.
• General on-site monitoring to ensure study staff are properly trained and equipped to safely enter patients into the study.
• Ensure the protection of study patients by verifying adherence to informed consent procedures and protocol requirements according to applicable regulatory requirements.
• Ensure the integrity of 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.
• 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.

Requirements

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).
• 2 years of Clinical Monitoring experience.
• 60% overnight travel.

The ideal candidate is comfortable working in an environment that is:

• Fast-paced: where no deviations from the study protocol are allowed, and not meeting timelines can create quality issues.
• Changing priorities constantly, requiring you to prioritize and adapt on the spot.
• Teamwork and people skills are essential for smooth study operations.
• Technology-based, with data collected directly into an electronic environment.

Work 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.

Physical Requirements

• Ability to sit for extended periods and operate a vehicle safely.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Occasional crouching, stooping, with frequent bending and twisting of the 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 (or otherwise moving) objects including luggage and a laptop computer, with a maximum lift of 15-20 lbs.
• Regular and consistent attendance.
• Varied hours may be required.

Pay

Target pay range: $100,000 - $112,000 per year.