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

Role Summary

Sr CRA or CRA 2 – Oncology – FSP – Northeast US. Experienced Oncology CRAs residing in the Northeast with regional travel (40-60%) to locations including 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 the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document monitoring and 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 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.

Qualifications

• University or college degree, or certification in a related allied health profession from an 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

• Strong clinical judgment and ability to respond to emergencies in clinical trials.
• Ability to work in a fast-paced environment with strict adherence to study protocols and timelines.
• Teamwork and strong interpersonal skills; proficient in electronic data capture environments.

Education

• As listed in Qualifications above (degree or equivalent certification in a related allied health field).

Additional Requirements

• Frequent travel to client/site locations; both domestic and international travel as required.
• Remote/hybrid work arrangement as applicable.