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Independently manages Phase I–III oncology clinical trial sites from study start-up through close-out. Conducts qualification, initiation, interim monitoring, and close-out visits; ensures compliance with protocols, GCP, ICH, FDA regulations, and clinical objectives. Develops monitoring plans, collaborates with investigators and site staff to resolve issues, and prepares monitoring reports and follow-up documentation. This is a field-based role requiring approximately 50% overnight travel.
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
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.
Essential Functions:- 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.
- 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
Born from the Translational Genomics Research Institute (TGen), TD2 was formed in 2003 as a subsidiary of TGen, and less than two years later, opened its doors on the campus of the Mayo Clinic in Scottsdale, Ariz. In our 17 years of business, we have helped more than 600 biotech and pharma companies, maintaining hundreds of client studies per year. Among them, our team has been involved in more than 600 first-in-man major oncology medicines, including numerous trials that have led to approvals in both rare and large indications.
TD2 is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, creed, disability, veteran’s status, gender, sexual orientation, gender identity, or gender expression.
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