Sr. CRA 2, FSP - Invitro Diagnostics - Midwest

About the role

Our FSP team is currently seeking Sr. CRA 2s with 4+ years of monitoring experience residing in the Midwest US. You will utilize your skills, knowledge, and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards.

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; 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
• Ensure the integrity of the 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 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

• 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+% overnight travel

Work environment

Work is performed in an office environment with exposure to electrical office equipment. Frequent travel to client/site locations with occasional travel both domestic and international. The role requires comfort in a fast-paced environment where no deviations from the study protocol are allowed and timelines are critical; changing priorities require constant prioritization and adaptation; teamwork and people skills are essential; and the work is technology-based with data collected directly into electronic systems.

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

Pay

Target pay range: $130,000 - $142,000 per year.

Schedule

50+% overnight travel required. Frequent travel to client/site locations with occasional domestic and international travel. Varied hours may be required.