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 clinical trials to ensure the protection and welfare of subjects, compliance with the protocol, GCP/ICH guidelines, FDA regulations and overall clinical objectives.
This may include both on-site and remote monitoring.
Perform site qualification, site initiation, interim monitoring and site close-out visits according to TD2 policies and procedures.
Perform 100% source data verification (SDV) unless a risk-based monitoring approach is deemed appropriate for the trial, to ensure source documentation and case report forms (CRFs) are consistent with protocol requirements, ICH/GCP and ALCOA principles.
Interface with principal investigators and site staff routinely to ensure timely resolution of issues, proper trial oversight and to bring conflicts with the PI and site staff to a favorable conclusion.
Proactively identify site issues and provide retraining for site personnel to avoid the occurrence or reoccurrence of major deviations.
Write Site Visit Reports after each visit and prepare Confirmation and Follow-up Letters as per TD2 policies/procedures and Monitoring Plan.
Work with the Project Manager to write and approve the trial Monitoring Plan.
Ensure the site maintains appropriate documentation in the regulatory binder.
Manage the site to include consistent follow-up and resolution of site issues, data/query management and TMF reconciliation.
Work with the site proactively to provide essential documents for filing within the Trial Master File.
Assist management with the training of new or less experienced staff.
Immediately report any suspected fraud, misconduct, or serious breaches in the trial to the PM and/or supervisor.
Co-monitor and mentor junior CRAs as needed.
Work with other departments to ensure study timelines and deliverables are met.
Maintain appropriate CRA training requirements as per the TD2 Training Matrix.
Performs other responsibilities as assigned.
Job Requirements:
This position requires at least a Bachelor’s degree or international equivalent with preference to a health science field. Equivalent work experience may be substituted for education at TD2’s discretion.
Minimum experience of at least 5 years’ in CRA monitoring Phase I and Phase II clinical trials.
Minimum experience of at least 4 years’ in the therapeutic field of oncology.
Minimum 5 years’ working as a CRA in a CRO or pharmaceutical environment.
Required Specialized/Technical Skills:
Strong knowledge of the drug development process with experience monitoring complex adaptive design clinical trials.
Advanced experience in the therapeutic area of oncology.
Strong working knowledge of MS Office products including Word, Excel, and PowerPoint.
Strong knowledge of regulatory (e.g., GCP, ICH, FDA regulations), technical, and clinical conduct of oncology clinical research trials.
Understanding of the principles of clinical monitoring with ability to effectively mentor/guide clinical trial site staff.
Excellent problem-solving skills.
Excellent verbal and written communications skills with an ability to distill regulatory concepts into compelling discussions.
Able to work under tight timelines.
Ability to travel extensively (75%) within North America as a main part of this position.
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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