Description
Our FSP team is currently seeking Sr. CRA 2s with 4+ years of monitoring residing in the Midwest US!
You will utilise 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
- Conduct 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 monitoring and data verification
- 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 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
- 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
Target Pay Range: $130 - $142K