Sr CRA or CRA 2 - Oncology - FSP - Northeast US

Role Summary

Sr CRA or CRA 2 – Oncology – FSP – Northeast US. Experienced Oncology CRAs located in the North East with regional travel (40-60%). Opportunities in New York, New Jersey, Pennsylvania, Massachusetts, Connecticut, Virginia, DC, Pittsburgh, and surrounding areas.

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 applicable regulatory requirements
• Ensure the integrity of 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, 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
• 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)
• 3+ years of onsite Clinical Monitoring experience
• Oncology experience required
• Open to major hub locations in the Northeast US

Skills

• Ability to work in a fast-paced, high-accuracy environment with strict protocol adherence
• Strong communication and teamwork skills
• Proficiency with electronic data capture and data management systems

Education

• Degree or certification as described in Requirements

Additional Requirements

• Frequent travel to clients/site locations; willingness to travel domestically and internationally as needed
• Ability to sit for extended periods, operate a vehicle safely, and lift up to 15-20 lbs as part of job duties