Clinical Trial Associate

Clinical Trial AssociateRepertoire Immune Medicines is a biotechnology company dedicated to creating treatments for diseases based on the power of the human T cell repertoire to eliminate cancer cells, target pathogens and regulate immune function in autoimmune disease.Repertoire Immune Medicines is a clinical-stage biotechnology company harnessing the power of the human immune system to develop transformative therapies for cancer and autoimmune disease. Using its proprietary DECODETM platform—which maps the immune synapse between T cell receptors (TCRs) and their antigen targets—Repertoire translates unique biological insights into potent, targeted immune medicines. The company integrates deep protein engineering expertise and has established collaborations with several leading pharmaceutical companies, including Bristol Myers Squibb, Genentech, Eli Lilly, and Pfizer. Repertoire is advancing a pipeline of TCR bispecific immunotherapies with the potential to address a broad range of cancers and autoimmune disorders. The company's lead oncology program, RPTR-1-201, a TCR bispecific, is currently in a Phase 1/2 clinical trial across multiple solid tumor indications. Repertoire plans to advance additional TCR bispecific therapies into clinical trials over the next 12–18 months. The Clinical Trial Associate will play a central role in supporting these programs.Repertoire Immune Medicines is seeking a highly motivated Clinical Trial Associate (CTA) to join our Clinical Operations team and support the execution of early-phase oncology clinical trials. The CTA will provide critical operational support in execution of clinical trials across trial start-up, conduct, maintenance, and close-out activities. In this role, the CTA will work closely with the Director of Clinical Operations and the Clinical Trial Manager, cross-functional team members, CROs, vendors, and clinical sites to help ensure timely, high-quality operational execution of clinical trial activities in compliance with ICH-GCP, applicable FDA and global regulatory requirements, GDPR/HIPAA where relevant, and Repertoire SOPs. The ideal candidate is detail-oriented, highly organized, proactive, and comfortable working in a fast-paced biotech sponsor environment, with experience supporting oncology and early-phase clinical trials preferred. The successful candidate will also value a highly collaborative, in-person team culture and be expected to work on-site in our Cambridge office three or more days per week.Support operational full life cycle execution of early-phase oncology clinical trials in accordance with protocol requirements, ICH-GCP, applicable global regulations, and company SOPs.Coordinate trial activities across multiple functional areas, CROs, vendors, and clinical sites to support timely execution of trial deliverables and milestones.Identify operational issues, assess potential impact to trial timelines or compliance, and escalate risks or mitigation recommendations to Clinical Operations leadership as appropriate.Support site activation, readiness for investigational product release, trial supply coordination, and issue resolution activities.Maintain trial trackers, distribution lists, reports, and clinical systems.Track trial progress, including key milestones, vendor deliverables, enrollment, monitoring activities, and trial action items.Manage, organize, and maintain trial documentation to support inspection readiness and perform TMF quality checks including identification and resolution of documentation gaps, inconsistencies, and compliance risks.Support preparation, review, tracking, and maintenance of regulatory and IRB/IEC documentation in collaboration with internal and external stakeholders.Support audit and inspection readiness activities, including document retrieval, issue tracking, and follow-up coordination.Track protocol deviations, operational issues, and compliance concerns, including escalation of significant risks to trial leadership.Serve as an operational contact for CROs, vendors, and clinical sites under the direction of Clinical Trial Manager.Coordinate trial meetings, prepare agendas and minutes, document key decisions and action items, and support timely follow-up and resolution of operational priorities.Support operational oversight of CRO and vendor deliverables, timelines, and issue escalation activities.Coordinate exchange of trial information and materials across cross-functional stakeholders to support execution and inspection readiness.Exercise independent judgment in prioritizing competing operational activities and managing multiple trial deliverables.Bachelor's degree in life sciences, health sciences, nursing, public health, or related field.Minimum of 2 years of experience supporting clinical operations, clinical research, or clinical trial execution activities.Working knowledge of ICH-GCP, FDA regulations, and clinical trial processes within a biotech, sponsor, CRO, or research environment.Experience with clinical systems and tools such as eTMF, EDC, CTMS, Smartsheet, Box, and Microsoft Office applications.Strong organizational, analytical, and problem-solving skills with demonstrated ability to prioritize competing activities and manage multiple deliverables.Ability to identify operational risks, support issue resolution, and escalate quality or compliance concerns appropriately.Strong communication and cross-functional collaboration skills with internal and external stakeholders.Experience supporting oncology or early-phase clinical trials is preferred.