Clinical Trial Associate II (Contractor)

Role Summary

The Clinical Trial Associate (CTA) II is responsible for the coordination of clinical operations activities, collaborating with cross-functional teams, CROs, consultants, vendors, and clinical trial sites, and ensuring adherence to Good Clinical Practices and applicable regulations. This role supports timely conduct of clinical studies according to protocols and SOPs, requiring strong organizational and communication skills.

Responsibilities

• Act as the clinical link to the clinical operations team, clinical research associates, vendors, and investigational sites.
• Facilitate timely and effective communication among team members and site staff; partner with cross-functional teams as needed.
• Receive, process, and track temperature excursion reports.
• Collaborate with the senior clinical operations team to develop the study-specific Pharmacy Manual.
• Track monitoring visits, site visit reports, and site documentation submitted by CRAs according to monitoring plan and SOP requirements.
• Review monitor visit reports and follow up on action items.
• Gather, track, and support maintenance of key study performance indicators for sites (e.g., participant enrollment, SAEs).
• Participate in site start-up activities; collect, review, and assemble site essential regulatory documents per procedures and SOPs.
• Manage regulatory documentation according to guidelines and TMF plan.
• Submit/track protocols, amendments, and research submissions to IRBs/ECs.
• Assist with TMF specifications, study-specific plans, and ongoing submission of documents to the TMF.
• Serve as clinical TMF subject matter expert and support central filing and QC reviews of TMF documents.
• Develop study-specific document tracking systems to ensure collection and maintenance of required documents.
• Assist with the review and editing of clinical documents for accuracy, consistency, and regulatory compliance.
• Prepare study start-up materials and tools as needed.
• Attend clinical monitoring staff meetings and training sessions; schedule meetings and draft minutes as needed.
• Order and assemble study supplies and patient retention materials (e.g., ID cards, appointment cards, IBs, Protocols, Regulatory Binders).

Qualifications

• B.A./B.S. degree in science/healthcare or related field.
• 3+ years of clinical research experience in biotechnology or pharmaceutical industry.
• Working knowledge of GCP, ICH, and FDA regulatory requirements for clinical trials.
• Strong organizational, documentation, and interpersonal skills.
• Ability to work in a team-oriented environment and manage multiple tasks to meet deadlines.
• Excellent written and oral communication skills; proficient with Excel, Word, PowerPoint; solid presentation skills.
• Basic understanding of ongoing protocols and disease-related terminology; basic knowledge of the drug development process.
• Ability to sit for prolonged periods; occasional light lifting and repetitive hand movements; basic office tasks.
• Occasional travel required.

Skills

• Communication and collaboration
• Regulatory documentation and TMF management
• Monitor visit coordination and site documentation tracking
• Documentation and quality assurance
• Study start-up and materials management
• Data organization and project coordination

Education

• B.A./B.S. in science, healthcare, or related field

Additional Requirements

• Occasional travel as needed