.jpg)
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.
#LI-Remote
Skills Required
- Minimum five years of experience as a Clinical Research Associate in a CRO or sponsor organization
- Minimum five years of experience monitoring Phase I oncology clinical trials
- Minimum four years of experience in oncology
- Strong knowledge of GCP, ICH, and FDA regulatory requirements
- Excellent presentation skills
- Strong computer skills with Microsoft Office, Site EMR, EDC, and CTMS systems
- Ability to work in a field-based role with 50% overnight travel
What We Do
Translational Drug Development (TD2) is an oncology-focused Contract Research Organization (CRO) that supports improved and accelerated development of medicines for life-threatening diseases. We help companies move their drugs through the critical stages of preclinical, regulatory and clinical trial processes. Our scientific depth, proactive problem solving, and strategic direction and advice increase the likelihood of positive outcomes that bring hope and a better quality of life to cancer patients and their families. TD2 was born from the Translational Genomics Research Institute (TGen) as a nonprofit in 2003. TGen’s deep scientific expertise and approach to interrogating the “omic” drivers of disease is at the heart of TD2’s heritage and has become the foundation upon which TD2 creates unique clinical strategies for its clients.
