Clinical Trial Associate

Clinical Trial Associate Waltham, MA Job Details Full-time 19 hours ago Qualifications Biotechnology Document review (document control) Microsoft Outlook Presentation software Logistics management Bachelor of Science Mid-level Analysis skills ICH guidelines Clinical research compliance Bachelor's degree Medication supplies Order placement 1 year

Oncology Full Job Description 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 clinical studies across our hematological and solid tumor programs. 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.

About TScan:

TScan Therapeutics was founded in 2018 by a small group of scientists led by Dr. Stephen Elledge (Harvard Medical School/HHMI). TScan is discovering and developing novel TCR-engineered T cell therapies for the treatment of cancer. TScan's discovery platform is centered around a breakthrough technology that enables the rapid, comprehensive, and genome-wide identification of the peptide antigen targets of T cell receptors. This technology greatly enhances our ability to understand the specific antigens that drive important disease processes, including tumor cell recognition by the immune system, self-reactivity in autoimmune disorders, and acquired immunity in infectious disease. TScan is using the platform in oncology to discover new TCR/target pairs and to rapidly move novel TCRs into clinical development.

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. 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 Do YOU have the anatomy of a TScanner? Our talented, compassionate and intelligent team is what makes TScan a great place to work. Our brand new offices with approximately 40,000 square feet of premium lab and office space is an environment that supports innovation, camaraderie and professionalism. We are driven, 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. Pay Transparency TScan Therapeutics' pay ranges are established based on external market data from third-party compensation surveys and our internal benchmarking. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Individual compensation within this range is commensurate with a candidate's specific qualifications, including education, overall experience, relevant experience, and specific skills. We strive to ensure that compensation is competitive, equitable, and aligned with the value each TScanner brings to the role. 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.