What are the responsibilities and job description for the Clinical Trial Associate position at TScan Therapeutics?
Position Summary:
TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for a Clinical Trial Associate to join our Clinical Operations team to support the execution of our Phase 1 basket study in solids. The ideal candidate should have experience in supporting the execution of oncology clinical studies as well as a working knowledge of ICH GCP regulations. The candidate should a enjoy fast-paced, collaborative, and vibrant startup culture. A team player with a sense of urgency will thrive in this role.
Responsibilities:
- Work closely with the Clinical Operations team in accordance with internal SOPs and GCP to coordinate and track study logistics, study status, enrollment, invoices, documentation, site start-up, etc.
- Support the drafting and review of study-specific documents including, but not limited to, informed consent forms, regulatory documents, site training documents, etc.
- Maintain tracker of lab and biomarker results
- Follow up with sites to track patient status and timing for enrollment
- Act as a liaison and resource for external partners including CROs, vendors, investigators, and others to provide information and resolution for study requests and issues
- Work with internal supply chain and manufacturing team to place orders for manufacturing, including forecasting drug supply needs, tracking incoming leukopaks and tracking outgoing cell therapy products.
Requirements:
- BS in scientific or healthcare discipline with 1- 3 years experience in clinical trial management at a CRO, pharmaceutical/biotechnology company or hospital setting
- Strong computer skills, including Excel, Word, Outlook, and PowerPoint
- Knowledge of GCP guidelines and demonstrated experience supporting clinical trials
- Excellent interpersonal skills and ability to build strong professional relationships internally and externally
- Strong analytical and problem-solving skills
- Strong attention to detail in drafting materials, establishing priorities, scheduling, and meeting deadlines
About TScan:
TScan Therapeutics is a fully integrated, next-generation TCR-T cell therapy company. Founded in 2018, TScans platform was developed by Stephen Elledge, Ph.D., and Tomasz Kula, Ph.D., at Brigham and Womens Hospital and Harvard Medical School. TScans transformative platform enables rapid discovery of TCRs and targets for engineered T cell therapy. This technology is extremely versatile and is applicable across multiple therapeutic areas beyond cancers, including autoimmune disorders and infectious diseases.
Do YOU have the anatomy of a TScanner?
Our talented, compassionate, and intelligent team is what makes TScan a Top Place to Work (as ranked by The Boston Globe). Our state-of-the-art offices with over 70,000 square feet of premium lab space, including an internal GMP manufacturing suite, are an environment that supports innovation, camaraderie, and professionalism. We are passionate, fun, flexible, and team oriented. Sound like you? Apply today.
EEO Statement
TScan is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, citizenship status, sexual orientation, gender identity or expression, or any other characteristic identified by federal, state, or local laws where we operate. TScan provides reasonable accommodations to qualified applicants and employees with disabilities. To begin an interactive dialogue with TScan regarding a reasonable accommodation in connection with the hiring process and/or to perform the responsibilities of the position for which the applicant has applied, please contact the recruiter.
Recruitment & Staffing Agencies
TScan Therapeutics does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to TScan Therapeutics or its employees is strictly prohibited unless contacted directly by TScan Therapeutics internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of TScan Therapeutics, and TScan Therapeutics will not owe any referral or other fees with respect thereto.
