We are seeking a highly motivated individual to join TP Therapeutics as a Clinical Trial Associate (CTA) within the Clinical Operations Team, reporting into the Director of Clinical Operations. The Clinical Trial Associate is responsible for the oversight and management of clinical operations activities or projects. The CTA will interact with Clinical Operations teams and collaborate effectively with CROs, vendors and clinical trial sites. The CTA supports the timely conduct of clinical studies according to protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all applicable regulations governing the conduct of clinical trials.
- Support all aspects of TP Therapeutics’ clinical trials from initiation, planning, execution, maintenance and close-out.
- Collaborate/Interact with CROs, vendors and clinical study sites
- Support patient enrollment and data collection are completed in accordance with study timelines and objectives.
- Review and assess study documents required for site activation and investigational product release.
- Review Site selection/Visit reports: Qualification Visits, Initiation Visit Reports and Interim Monitoring Visit Reports on an ongoing basis.
- Schedule, set- up and minute study team and vendor meetings, as applicable.
- Maintain metrics on results of study documentation reviews.
- Support in the review of invoices from vendors/consultants as per contract.
- Support in the review of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IxRS specification process and UAT.
- Support the planning of Investigator Meetings and/or Site and CRA trainings.
- Manage the oversight of sample collection (i.e., tissue samples, lab samples, scans, PK samples).
- Ensure all relevant documents are uploaded into the Electronic Trial Master File (eTMF).
- Manage the exchange of TMF documents with external service providers, as applicable.
- Perform periodic reviews and QC of the Trial Master File.
- Provide applicable essential documents to Regulatory for submission to the FDA.
- Serve as a liaison and resource for investigational sites.
- Participate in Site Initiation Visits and Co-monitoring Visits, as required.
- Additional Operations activities may be assigned as appropriate.
- Travel as required to carry out responsibilities.
- Participate in the development, review and implementation of departmental SOPs and processes.
- Bachelors or equivalent in a scientific or health care field preferred.
- Minimum of 1-3 years of relevant experience required.
- Experience in oncology clinical trials preferred.
- Clinical operations experience at a small or mid-size company.
- Comfortable in a fast-paced small biotech company environment and able to adjust workload based on changing priorities.
- Knowledge of ICH/GCP guidelines, regulatory requirements and clinical trial operations.
- Excellent verbal and written communication skills.
- Ability to collaborate and respond to changing circumstances and needs.
- Ability to travel up to approximately 15-20%.
EEO & Employment Eligibility
- TP Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. TP Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. TP Therapeutics is an E-Verify employer.
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