Experienced 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. The role involves 60-70% travel with 8-10 days on site (DOS) per month.

Responsibilities

• Utilize 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.
• Handle 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.
• Ensure study staff have received proper materials and instructions to safely enter patients into the study.
• Verify protection of study patients by ensuring 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 for missing or implausible data.
• Handle 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 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).
• 6 months to 2 years of Clinical Monitoring experience.
• Open to various hub locations within the US.

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.
• Dynamic: with changing priorities requiring you to adapt on the spot.
• Collaborative: where teamwork and people skills are essential for smooth study operations.
• Technology-driven: with data collected directly into an electronic environment.

Benefits

Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits, including but not limited to:

• Medical, Dental, and Vision insurance (multiple carriers).
• Life, Short-Term Disability (STD), and Long-Term Disability (LTD) insurance.
• 401(K) retirement plan.
• Paid time off (PTO) – Flex Plan.
• Employee recognition awards.
• Multiple Employee Resource Groups (ERGs).

Pay

Target pay range (based on title): $105,000 - $125,000.

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.