Clinical Trial Assistant

BioTalent; United States; Remote; USD 63,000 - 77,000; Full time

Job summary

BioTalent is seeking an experienced Clinical Trial Assistant (CTA) to provide essential operational support to a growing Clinical Operations team. This role focuses on ongoing multi-site trials, coordinating with Project Managers, CRAs, and study leadership to ensure smooth day-to-day operations.

The successful candidate will have strong organizational skills, the ability to manage multiple priorities, and a proactive approach to escalating issues as needed.

Qualifications

• Previous CTA/CRA/clinical operations support experience in CRO/biotech/pharma.
• Good understanding of clinical trial operations and documentation requirements.
• Familiarity with Trial Master File (TMF) management.
• Excellent organizational skills with the ability to manage competing priorities.
• Demonstrated ability to work independently and proactively follow up on tasks.

Responsibilities

• Provide daily operational and administrative support to Project Managers, CRAs, and study leadership.
• Assist with TMF and essential document management, including quality control and filing.
• Monitor outstanding site and CRA activities and ensure timely follow-up.
• Support site start-up and activation by tracking documentation and dependencies.
• Maintain training records, system access trackers, onboarding checklists, and logs.
• Coordinate routine communications with clinical sites and internal teams.
• Prepare and distribute study-related materials (newsletters, enrollment updates, meeting agendas).
• Assist with document routing, tracking, and study record maintenance.
• Keep site contact details accurate and follow up on undelivered communications.
• Identify overdue activities and escalate issues to the appropriate team.

Skills

CTA experience

Clinical trial operations

Organizational skills

Attention to detail

Communication skills

Independent work

Job description

Location: Remote – United States (Eastern or Central Time Zone preferred)

Employment Type: Full-Time

Salary: $70,000 annually

About the Role

We are seeking an experienced, highly organized, and proactive Clinical Trial Assistant (CTA) to provide essential operational support to a growing Clinical Operations team.

This position will initially focus on supporting an ongoing, multi-site clinical trial, working closely with Project Managers, Clinical Research Associates (CRAs), and study leadership to ensure smooth day-to-day operations. Responsibilities will include study administration, document management, site coordination, tracking deliverables, and ensuring timely follow-up on outstanding activities.

As the clinical portfolio expands, there may be opportunities to support additional studies and programs.

The ideal candidate will bring a solid understanding of clinical trial operations, strong organizational skills, and the ability to independently manage multiple priorities. This role requires someone who can anticipate needs, take initiative, and recognize when issues require escalation.

Key Responsibilities

• Provide daily operational and administrative support to Project Managers, CRAs, and clinical study leadership.
• Assist with Trial Master File (TMF) and essential document management, including quality control, document naming, filing, and follow-up.
• Monitor outstanding site and CRA activities, ensuring timely follow-up and resolution of open items.
• Support site start-up and activation by tracking required documentation, outstanding requirements, and key dependencies.
• Maintain accurate training records, system access trackers, onboarding checklists, and study-related logs.
• Coordinate routine communications with clinical sites and internal study teams.
• Prepare and distribute study-related materials, including newsletters, enrollment updates, meeting agendas, and CRA meeting notes.
• Assist with document routing, administrative tracking, and maintenance of study records.
• Ensure site contact information remains accurate and follow up on unsuccessful or undelivered communications.
• Proactively identify overdue activities, potential delays, or unresolved issues and elevate them to the appropriate team members.

Qualifications & Experience

Required / Strongly Preferred:

• Previous experience as a Clinical Trial Assistant (CTA), Clinical Trial Associate, Clinical Research Assistant, or in a similar clinical operations support role within a CRO, biotechnology, or pharmaceutical organization.
• Good understanding of clinical trial operations, processes, and documentation requirements.
• Familiarity with Trial Master File (TMF) management and essential clinical trial documentation.
• Excellent organizational skills, attention to detail, and ability to manage competing priorities.
• Demonstrated ability to work independently, take initiative, and proactively follow up on outstanding tasks.
• Strong written and verbal communication skills.
• Ability to work effectively in a fast-paced clinical research environment.
• Must be based in the United States, preferably within the Eastern or Central Time Zone.

Preferred Qualifications:

• Experience supporting complex, multi-site clinical trials.
• Previous experience collaborating closely with Clinical Research Associates and Project Managers.
• Experience joining ongoing clinical studies and helping organize outstanding activities and deliverables.
• Strong proficiency in maintaining study trackers, managing data, and coordinating documentation.

What We're Looking For

We are looking for a dependable and detail-oriented professional who can serve as a key operational resource for the clinical study team.

The successful candidate will help streamline administrative processes, maintain consistent communication and follow-up, and ensure that Project Managers and CRAs can focus on their core clinical trial responsibilities.

This is an excellent opportunity for an experienced CTA who enjoys being hands-on, taking ownership of responsibilities, and contributing to the successful execution of clinical trials.