Clinical Trial Associate
Position Summary
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.
Key Responsibilities
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.
Capture and 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.
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.
Qualifications
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.
Pay
The base salary for this role ranges from $62,000 to $86,000 and is determined based on a candidate’s skills, experience, and internal equity. In addition to a competitive base salary, Repertoire offers a broad range of benefits designed to attract, retain, and motivate top talent, including medical, dental, vision, and life insurance, flexible time off, a 401(k) retirement plan, and short- and long-term incentive opportunities.