Clinical Trial Associate II (Contractor)

Role Summary

The Clinical Trial Associate II (Contractor) coordinates clinical operations activities, ensuring adherence to GCP, SOPs, and regulatory requirements. Works with cross-functional teams, CROs, vendors, and trial sites to facilitate timely conduct of clinical studies.

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 and site documentation submitted by CRAs according to monitoring plan/SOPs.
• Review monitor visit reports and follow up on action items.
• Track and support maintenance of key study performance indicators (e.g., participant enrollment, SAEs).
• Participate in site startup activities, collecting and assembling essential regulatory documents per procedures/SOPs.
• Manage regulatory documentation according to TMF guidelines and plan.
• Submit/track protocols, amendments, and submissions to IRBs/ECs.
• Assist with TMF specifications, study-specific plans, and document submissions to the TMF.
• Serve as TMF subject matter expert; support central filing and TMF QC reviews.
• Develop study-specific document tracking systems to ensure collection and maintenance of required documents.
• Assist with review and editing of clinical documents for accuracy 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.
• Order and assemble study supplies and retention materials (ID cards, appointment cards, IBs, Protocols, Regulatory Binders).

Qualifications

• B.A./B.S. in science/health care or related field.
• 3+ years of clinical research experience in biotechnology or pharmaceutical industry.
• Working knowledge of GCP, ICH, and FDA regulatory requirements governing clinical trials.
• Strong organizational, documentation, and interpersonal skills.
• Team-oriented mindset; ability to handle multiple tasks to meet deadlines.
• Excellent written and oral communication skills; strong computer skills (Excel, Word, PowerPoint) and presentation skills.
• Ability to sit for prolonged periods; use of hands for keyboard and manual tasks; occasional travel required.

Skills

• Clinical trial coordination
• Regulatory documentation management
• TMF documentation and tracking
• Site start-up and monitoring support
• Cross-functional collaboration
• Problem-solving and attention to detail

Education

• B.A./B.S. degree in science/health care or related field

Additional Requirements

• Occasional travel as needed
• Contract position requiring 40 hours per week