Clinical Trial Associate Jobs

About The Position

Requirements

• Two to three or more years of clinical operations experience in biotechnology, pharmaceutical, or CRO settings.
• Experience supporting Phase 1–3 clinical trials.
• Hands-on experience with TMF management and clinical systems such as eTMF, CTMS, and EDC.
• Working knowledge of ICH/GCP and applicable regulatory requirements.
• Strong organizational skills and exceptional attention to detail.
• Ability to manage multiple priorities in a fast-paced, collaborative environment.
• Excellent written and verbal communication skills.

Nice To Haves

• Bachelor’s degree in a scientific or healthcare-related field; equivalent experience will be considered.
• Experience in a small or early-stage biotech company.
• Experience supporting audit or regulatory inspection readiness.
• Experience working with global or multi-site clinical trials.
• Prior CRO oversight experience.

Responsibilities

• Independently support and coordinate clinical trial activities from start-up through close-out.
• Partner with Clinical Trial Managers to ensure operational milestones, timelines, and deliverables are achieved.
• Own Trial Master File quality, completeness, and inspection readiness.
• Perform ongoing TMF quality control and resolve documentation gaps with internal teams and vendors.
• Collaborate with CROs, vendors, and investigative sites to ensure study milestones and deliverables are met.
• Track study timelines, identify risks, and proactively escalate issues.
• Support IRB/IEC submissions and review essential regulatory documents for compliance.
• Maintain accurate and timely data in clinical systems, including eTMF, CTMS, and EDC.
• Assist with developing and reviewing clinical documents, including protocols, informed consent forms, and study plans or manuals.
• Support preparation, review, and tracking of IRB/IEC submissions and regulatory documentation.
• Coordinate and track laboratory samples from investigative sites to central and specialty laboratories, ensuring timely shipment, reconciliation, and accurate documentation.
• Participate in internal and external meetings, including preparing agendas and meeting minutes and tracking action items.
• Prepare and manage study communications, including newsletters and study updates as needed.
• Contribute to audit and inspection preparation activities.

Benefits

• Competitive salary and a comprehensive compensation package.
• Generous paid time off and company-observed holidays.
• Medical, dental, and vision insurance.
• 401(k) retirement savings plan with matching employer contributions.
• Childcare and fertility benefits.
• Career development opportunities, including an annual budget for continued learning and training and skill development.