Senior CRA, Oncology

TD2 • Scottsdale, AZ

9d • Remote

About The Position

We are Translational Drug Development - TD2: the leading oncology CRO, developing novel treatments for patients that need them most. Our team is fully dedicated to oncology – it is all we do – combining innovation and expertise to quickly move your medicines from preclinical development into clinical trials. Adaptive and forward-thinking, we guide your therapy through the most critical development milestones from the lab to planning your regulatory and clinical strategy. Our ultimate goal? To help patients. Preferred Locations: East Coast to Mid-West Position Summary: This position is responsible for independently managing clinical trial research sites to ensure research trials are completed in compliance with the protocol, GCP, FDA regulations, ICH guidelines, and overall clinical objectives.

Requirements

• Minimum of five years of work as a CRA in a CRO or Sponsor
• Minimum of five years of experience monitoring Phase I oncology clinical trials
• Minimum of four years of experience in the therapeutic field of oncology
• Strong knowledge of GCP, ICH, and FDA regulatory requirements
• Excellent presentation skills
• Strong computer skills in Microsoft Office tools, Site EMR, EDC, and CTMS systems
• Field-based with ability for 50% overnight travel

Responsibilities

• Monitor all aspects of assigned Phase I-III oncology clinical trials to ensure the protection and welfare of subjects, compliance with the protocol, GCP/ICH guidelines, FDA regulations, and overall clinical objectives.
• Managing clinical start-up through close-out activities.
• Organize and perform site qualification, site initiation, interim monitoring, and site close-out visits according to TD2 policies and procedures.
• Development of study specific clinical trial Monitoring Plan(s) for assigned studies.
• Establish efficient working relationships with clinical investigators and site staff to ensure timely resolution of issues and to assure proper trial oversite is occurring.
• Write Monitoring Visit Reports after each visit within the allotted timeframe along with preparing Confirmation and Follow-up Letters.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed