Clinical Trials Associate

About the role

We are seeking an energetic and highly motivated individual to join our Clinical Operations team. This position reports to the Head of Clinical Operations and offers the opportunity to significantly contribute to the growth and development of a top‑tier biotech company. The Clinical Operations Associate (COA) role focuses on supporting the planning, start‑up, maintenance, and closeout of clinical trials. The ideal candidate is proactive, detail‑oriented, and eager to be involved in all aspects of clinical trial execution.

Responsibilities

• Contribute to the development of study‑related documents (clinical protocols, informed consent forms, investigator brochures, monitoring plans, study manuals, etc.).
• Partner with investigators and clinical site staff to ensure optimal sponsor‑site relationships.
• Review study‑specific essential regulatory document packets prior to site activations.
• Participate in the ongoing review and cleaning of clinical trial data.
• Assist with the management of tracking, logistics, and quality operations for biological samples to maintain accurate inventories.
• Attend and support meeting scheduling, agenda preparation, and distribution of minutes.
• Review monitoring reports and protocol deviations to track issues and data trends at sites.
• Assist with investigational medicinal product (IMP) tracking to verify adequate supply at sites and depots.
• In conjunction with the CRO, manage submission of documents to and maintenance of the trial master file (TMF) to ensure continual inspection‑readiness.
• Support study finance and contract processes for third‑party vendors (invoice tracking, approval, and accruals).
• Effectively communicate trial details to keep all team members informed.
• Participate in SOP development and process‑improvement projects as needed.

Requirements

• BA/BS degree required.
• Minimum of 2 years relevant clinical research experience working at an investigator site, sponsor, or clinical research organization.
• Working knowledge of ICH/GCP guidelines and FDA regulations.
• Ability to collaborate effectively with cross‑functional team members and external partners.
• Strong organizational and time‑management skills, with the capacity to work independently and prioritize multiple projects.

Preferred qualifications

• Experience working with electronic trial master files (eTMFs) strongly preferred.