Barrington James
Barrington James
United States
2024-10-08
Job Title: Clinical Trial Associate (CTA)
Location: Remote
Employment Type: Full-time
Reports To: Clinical Project Manager
Client: Mid-sized Biopharmaceutical Sponsor (200 Employees)
About Our Client:
Our client is a dynamic, mid-sized biopharmaceutical sponsor company dedicated to advancing innovative therapies aimed at improving patient health outcomes. As they continue to grow, they are seeking a Clinical Trial Associate (CTA) to join their clinical operations team. This is a fantastic opportunity to be part of a collaborative and mission-driven organization that values its employees and fosters an environment of professional growth.
As a CTA, you will play a key role in supporting the clinical trials that are vital to the company’s mission. This is an exciting chance to be part of a small but impactful team, working closely with leading experts in the biopharmaceutical industry to bring life-changing treatments to market.
Position Summary:
In this role, the Clinical Trial Associate (CTA) will be responsible for providing essential support to the clinical operations team throughout the various phases of clinical trials, from initiation to close-out. You will ensure that all clinical trial documentation is properly maintained, trial-related activities are coordinated efficiently, and compliance with regulatory standards is upheld. The ideal candidate is detail-oriented, organized, and comfortable managing multiple projects in a fast-paced environment.
Key Responsibilities:
Clinical Trial Documentation: Manage the trial master file (TMF), ensuring all essential documents are accurately maintained, organized, and meet GCP and regulatory requirements.
Coordination Support: Assist the Clinical Trial Manager (CTM) with the planning and execution of clinical trial activities, including document preparation, vendor communication, and meeting coordination.
Regulatory Submissions: Prepare, review, and submit regulatory documentation to Ethics Committees/IRBs, Health Authorities, and other relevant bodies.
Site Support: Coordinate site selection, qualification, and initiation activities; track the performance and compliance of clinical trial sites.
Communication Hub: Serve as a liaison between clinical trial sites, vendors, and internal teams, facilitating clear and consistent communication across all stakeholders.
Compliance Monitoring: Ensure that clinical trials are conducted in alignment with protocols, SOPs, ICH-GCP guidelines, and relevant regulations.
Logistics Coordination: Oversee the shipment and tracking of investigational products, lab kits, and other study materials to clinical sites.
Meeting Organization: Arrange and manage logistics for study-related meetings, such as Investigator Meetings, Site Initiation Visits, and Data Safety Monitoring Board meetings; document minutes and follow up on action items.
Monitoring Support: Help coordinate study site monitoring visits and audits as needed.
Data Management Collaboration: Support clinical data management efforts to ensure timely and accurate data collection and entry into the study database.
Qualifications:
Bachelor’s degree in life sciences, health sciences, or a related field.
1-3 years of clinical trial experience, ideally within a sponsor.
Knowledge of clinical trial processes, GCP, and regulatory requirements.
Strong organizational skills, with the ability to manage multiple projects in a fast-paced setting.
Excellent written and verbal communication skills.
Proficiency in Microsoft Office (Word, Excel, PowerPoint) and clinical trial management systems (e.g., CTMS, eTMF).
Attention to detail and strong problem-solving capabilities.
Ability to work both independently and collaboratively within a team.
Prior experience managing trial master files (TMF) and study start-up is a plus.
Why Join Our Client’s Team?
Opportunity to work closely with a passionate and talented team in a growing biopharmaceutical company.
Competitive salary and benefits package.
Direct impact on the success of clinical trials and the development of life-saving therapies.
Room for professional growth and development in a supportive, fast-paced environment.
Seniority Level
Associate
Employment Type
Full-time
Job Function
Information Technology
Industries
Research Services and Biotechnology Research
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