CRA 2

About the Role

We are seeking experienced CRA 2s to lead and support our Full Service Outsourcing team. Open to major hub locations within the US. 60-70% travel, 8-10 DOS per month.

Key Responsibilities

• 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.
• Responsible for 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 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 data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document monitoring.
• 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.

Requirements & Tech Stack

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).
• 6 months - 2 years of Clinical Monitoring experience.
• Open to various hub locations.

Work environment characteristics:

• Fast paced: No deviations from the study protocol are allowed, and not meeting a timeline for even a few minutes will create a quality issue.
• Changing priorities: Constantly asking you to prioritize and adapt on the spot.
• Teamwork and people skills are essential for the study to run smoothly.
• Technology based: Data is collected directly into an electronic environment.

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 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 moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Regular and consistent attendance.
• Varied hours may be required.