Clinical Trial Associate

About Repertoire Immune Medicines

Repertoire Immune Medicines is a clinical-stage biotech company focused on leveraging the human immune system to develop innovative therapies for cancer and autoimmune diseases. Utilizing its proprietary DECODETM platform, which maps the interaction between T cell receptors and antigen targets, the company translates unique biological insights into targeted immune medicines. Repertoire combines advanced protein engineering and collaborates with major pharmaceutical firms such as Bristol Myers Squibb, Genentech, Eli Lilly, and Pfizer. Their pipeline includes TCR bispecific immunotherapies with potential applications across various cancers and autoimmune conditions. The lead oncology candidate, RPTR-1-201, is in Phase 1/2 clinical trials for multiple solid tumors, with plans to progress additional therapies within 12 to 18 months.

Role Overview

The Clinical Trial Associate (CTA) will be a key contributor supporting early-phase oncology clinical trials within the Clinical Operations team. This role encompasses operational support across all stages of clinical trials including start-up, execution, maintenance, and close-out activities. The CTA will collaborate closely with clinical leadership, cross-functional teams, contract research organizations (CROs), vendors, and clinical site personnel to ensure timely and quality trial execution compliant with ICH-GCP, FDA and global regulations, GDPR/HIPAA as applicable, and company SOPs. The position requires a detail-focused, organized, and proactive professional comfortable in a dynamic biotech sponsor environment. On-site presence in Cambridge, MA for at least three days per week is expected to foster a collaborative team atmosphere.

Key Responsibilities

• Provide comprehensive operational support for the full life cycle of early-phase oncology clinical trials according to protocols and regulatory standards.
• Coordinate activities across multiple teams, CROs, vendors, and sites to meet trial deliverables and milestones on schedule.
• Recognize and evaluate operational challenges impacting timelines or compliance, escalating risks with mitigation proposals to leadership.
• Assist with site activation, investigational product release readiness, trial supply management, and troubleshooting.
• Maintain trial trackers, distribution lists, reports, and clinical data systems.
• Monitor trial progress concerning milestones, vendor responsibilities, enrollment, and monitoring activities.
• Organize and oversee trial documents to ensure inspection readiness; conduct Trial Master File quality control to identify and resolve discrepancies or compliance concerns.
• Support regulatory and ethics committee documentation preparation, tracking, and collaboration.
• Assist with audit and inspection preparations, including document management and follow-ups.
• Document protocol deviations, operational issues, and compliance events, escalating significant matters appropriately.
• Act as an operational liaison for CROs, vendors, and sites under Clinical Trial Manager guidance.
• Coordinate trial-related meetings, prepare agendas and minutes, and ensure action items are addressed timely.
• Oversee vendor and CRO deliverables, deadlines, and issue escalation processes.
• Facilitate information sharing among cross-functional teams to support trial conduct and audit readiness.
• Apply judgment to prioritize multiple competing operational duties and deliverables independently.

Qualifications

• Bachelor’s degree in life sciences, health sciences, nursing, public health, or related discipline.
• At least two years’ experience supporting clinical operations, clinical research, or clinical trial execution.
• Solid understanding of ICH-GCP guidelines, FDA regulations, and clinical trial procedures within biotech, sponsor, CRO, or research settings.
• Familiarity with clinical tools including electronic Trial Master File (eTMF), Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), Smartsheet, Box, and Microsoft Office.
• Excellent organizational, analytical, and problem-solving capabilities to manage priorities and multiple deliverables.
• Ability to recognize operational risks, facilitate resolution, and appropriately escalate compliance or quality issues.
• Strong communication skills and ability to collaborate effectively across diverse internal and external stakeholders.
• Prior experience supporting oncology or early-phase clinical trials is advantageous.

Compensation and Benefits

The position offers a base salary ranging from $62,000 to $86,000 determined by experience, skills, and internal equity. Repertoire provides a comprehensive benefits package including medical, dental, vision, life insurance, flexible time off, 401(k) retirement plan, and short- and long-term incentive programs. Compensation and benefits details are subject to updates.

Culture and Equal Opportunity

Repertoire values diversity and inclusion as a core strength, recognizing that varied perspectives drive superior outcomes. The company is an Equal Opportunity Employer committed to fostering an inclusive environment.

Recruitment Notice

Repertoire Immune Medicines does not accept unsolicited resumes from recruitment or staffing agencies unless contacted directly by internal HR. Any unsolicited submissions without agreements become company property without fee obligations.