CRA 2

About the Role

Seeking experienced CRA 2s to lead and support the 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 the 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).
• May act as a local client contact as assigned.
• Perform other duties as assigned by management.

Requirements & Tech Stack

• Clinical Monitoring experience: 0.5 - 2 years.
• Comfortable working in a fast-paced environment.
• Ability to work in an environment with changing priorities.
• Teamwork and people skills are essential.
• Technology-based environment; data collection directly into an electronic environment.
• Ability to access and use a variety of computer software.

Qualifications

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).

Work Environment

• Work is performed in an office environment with exposure to electrical office equipment.
• Frequent travel to clients/site locations with occasional travel both domestic and international.

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.
• 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.