Sr. CRA 2, FSP - Invitro Diagnostics

Responsibilities

• Utilize skills, knowledge, and clinical judgement to provide high standard of care for participants in clinical trials and respond to emergency situations.
• 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 the applicable regulatory requirements.
• Monitor data for missing or implausible data.
• Registry Management:
• 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.
• Training and Coordination:
• Aid in training of new employees, eg. 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.

Requirements

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure).
• 4+ years of Clinical Monitoring experience.
• 50-60% overnight travel.

Physical Requirements

• Ability to sit for extended periods and operate a vehicle safely.
• Frequent travel to clients/site locations with occasional travel both domestically and internationally.
• 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.
• Variable hours may be required.