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

Role Summary

Experienced Oncology Sr. CRAs residing on the East Coast to join our FSP team. The role involves monitoring clinical trial sites, ensuring protocol adherence, and supporting data integrity and patient safety in oncology studies.

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 data 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 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 monitoring and site management capabilities
• Data integrity assessment and CRF/ SAE handling
• Training and mentorship for new staff
• Effective communication with vendors, sites, and stakeholders
• Ability to work in a fast-paced, changing environment with a focus on protocol compliance

Education

• As listed in Qualifications

Additional Requirements

• Travel: Frequent travel to client/site locations with occasional travel both domestic and international
• Physical requirements: ability to sit for extended periods, operate a vehicle safely, occasional lifting up to 15-20 lbs, and standard computer use