Sr CRA 1 or Sr. CRA 2,FSP - Oncology - East Coast

Role Summary

Sr CRA 1 or Sr. CRA 2, FSP - Oncology - East Coast. Experienced Oncology Sr. CRAs residing on the East Coast to join our FSP team.

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
• 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 appropriately accredited institution (e.g., nursing licensure)
• 3+ years of onsite Clinical Monitoring experience
• Oncology experience
• Open to major hub locations in the Northeast US

Skills

• Strong clinical judgment and knowledge of clinical trial standards
• Excellent monitoring, data integrity, and regulatory compliance capabilities
• Effective communication with study staff, vendors, and clients
• Ability to work in a fast-paced, changing environment and prioritize effectively
• Proficiency with electronic data capture and clinical data management systems

Education

• As listed in Qualifications above

Additional Requirements

• Travel to client/site locations frequently; domestic and international travel may be required
• Ability to sit for extended periods; occasional lifting and physical requirements as described