We are seeking a highly motivated individual to join TP Therapeutics as a Clinical Research Associate (CRA) within the Clinical Operations Team, reporting into the Director of Clinical Operations. The Clinical Research Associate supports the Clinical Trial Managers and Director of Clinical Operations in the conduct of one or more clinical studies. The CRA will interact with the Clinical Operations team and collaborate effectively with CROs, vendors and clinical trial sites. The CRA 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.
- Assist in overseeing TP Therapeutics’ clinical trials from initiation, planning, execution, maintenance and close-out.
- Coordinate investigational site startup activities, including the creation, preparation, and shipment of documentation (e.g., ICFs, CRFs, study manuals, study binders, etc.), Ethics Committee submissions and approvals, reviewing/approving Essential document packages, reviewing site changes to ICFs, facilitating completion of clinical study agreements and budgets, and shipment of clinical supplies.
- Coordinate contract vendors and Clinical Research Organization activities to ensure all are conducted according to study plans, timelines, budgets, and relevant SOPs.
- Review invoices from vendors/consultants as per contract.
- Coordinate and maintain relevant tracking systems for subject screening, enrollment, study visits, data entry, query resolution.
- Review and approve Site selection/Visit reports: Qualification Visits, Initiation Visit Reports and Interim Monitoring Visit Reports on an ongoing basis.
- Participate in Site Initiation Visits.
- Conduct co-monitoring visits to oversee CRO personnel and study conduct at the site.
- 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.
- Assist in the planning of Investigator Meetings and/or Site and CRA trainings.
Assist with protocol, case report form, source document template development, internal SOP/guideline development, final report preparation.
- Review clinical databases on a real time basis to identify/resolve data entry issues, tracks the query process to identify/report evolving trends in the data.
- Coordinate the oversight of sample collection (i.e., tissue samples, lab samples, scans, PK samples).
- Coordinate the exchange of TMF documents with external service providers as applicable and periodic reviews and QC of the Trial Master File to ensure audit and inspection readiness.
- Serve as a liaison and resource for investigational sites.
- 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 required.
- Minimum of 2-3 years of CRA experience in the biotechnology or pharmaceutical industry required.
- Experience in oncology clinical trials preferred.
- Clinical operations experience at a small or mid-size company preferred.
- Comfortable in a fast-paced small biotech company environment and able to adjust workload based on changing priorities.
- Strong 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 25-30%.
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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