Sr Clinical Research Associate
- 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 principle investigators and site staff routinely to ensure timely resolution of issues, proper trial oversite 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.
- 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 six (5) years as a CRA monitoring Phase I and Phase II clinical trials.
- Minimum experience of a least four (4) years in the therapeutic field of oncology.
- Minimum five (5) years working as a CRA in a CRO or pharmaceutical environment.
Required Specialized/Technical Skills
- Strong knowledge in 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.
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