Gen Med CRA II & Sr. CRAs - Central, West & East Coast
Join to apply for the Gen Med CRA II & Sr. CRAs - Central, West & East Coast role at Fortrea
Gen Med CRA II & Sr. CRAs - Central, West & East Coast
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Join to apply for the Gen Med CRA II & Sr. CRAs - Central, West & East Coast role at Fortrea
We are currently seeking Experienced Gen Med CRAs to lead and support our Full Service Outsourcing team. Open to various hubs across the US.
What You Will Do
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 monitoring and data review 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 productions 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 accredited institution (e.g., nursing licensure).
- 1 - 3+ years of Clinical Monitoring experience.
- Gen Med experience is desired.
- Open to various hub locations.
The environment is fast-paced, requiring strict adherence to study protocols and timelines, with constantly changing priorities. Teamwork, strong people skills, and comfort with technology and electronic data collection are essential.
What do you get?
Benefits
Full-time or part-time employees working 20+ hours/week are eligible for benefits including:
- Medical, Dental, Vision, Life, STD/LTD insurance
- 401(k)
- Paid time off (PTO) – Flex Plan
- Employee recognition awards
- Multiple Employee Resource Groups (ERGs)
- Target Pay Range: $105-140K
Remote work options available. Applications are accepted on an ongoing basis. Learn more about our EEO & Accommodations policies.
Additional Details
- Seniority level: Mid-Senior level
- Employment type: Full-time
- Job function: Research, Analyst, and Information Technology
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