Clinical Trial Associate II (Contractor)

Role Summary

The Clinical Trial Associate (CTA) II is responsible for the coordination of clinical operations activities. The CTA II will interact with the Dynavax Clinical Operations and the cross functional team; collaborate effectively with CROs, consultants, vendors, and clinical trial sites; and assure adherence to Good Clinical Practices, investigator integrity and compliance with all study procedures. The CTA II facilitates the timely conduct of clinical studies according to protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all applicable regulations governing the conduct of clinical trials. The scope of this position requires excellent organizational and communication skills.

Responsibilities

• Act as the clinical link to clinical operations team, clinical research associates, vendors, and investigational sites.
• Facilitate timely and effective communication among team members and site staff; partners with the cross functional team, e.g., regulatory, medical, quality assurance, as needed.
• Responsible for the receipt, processing and tracking of temperature excursion reports.
• Work in collaboration with the senior clinical operations team to develop the study-specific Pharmacy Manual.
• Track monitoring visits, monitoring/site visit reports and site documentation submitted by CRAs according to monitoring plan and/or SOP requirements.
• Facilitate the review of monitor visit reports and follow up with monitoring report action items.
• Gather, track and support maintenance of key study performance indicators for sites, e.g., participant enrollment, SAEs, etc.
• Actively participate in site start up activities, such as, collect, review, and assemble site essential regulatory documents according to study procedures and SOPs.
• Manage current regulatory documentation according to essential regulatory document guidelines and Trial Master File (TMF) plan.
• Submit/track protocols, amendments, change in research submissions to IRBs/ECs.
• Assist with the establishment of TMF specifications, TMF study-specific plans, expected documents list and ongoing submission of documents to the TMF.
• Serve as clinical TMF subject matter expert, support the central filing of study documents and functional area QC reviews of the TMF documents.
• Participate in the development of study-specific document tracking systems to ensure the collection and maintenance of required documents.
• Assist with the review and editing of clinical documents to ensure accuracy, consistency, and regulatory compliance.
• Participate in the preparation of study start up materials and tools, as needed.
• Attend clinical monitoring staff meetings and clinical training sessions.
• Responsible for scheduling meetings and drafting meeting minutes, as needed.
• Order and assemble study supplies and patient retention materials such as ID cards, appointment cards, IBs, Protocols and Regulatory Binders.

Qualifications

• B.A/B.S. degree in the science/health care or other relevant field.
• 3+ years of clinical research experience in biotechnology or pharmaceutical industry required.
• Working knowledge of GCP, ICH, and FDA regulatory requirements governing clinical trials.
• Strong organizational, documentation and interpersonal skills.
• Willingness to work within a team-oriented environment.
• Ability to handle multiple tasks to meet deadlines in a dynamic environment.
• Excellent written and oral communication skills, strong computer skills (Excel, Word, PowerPoint) and solid presentation skills.
• Perform other work-related duties as assigned.
• Demonstrate basic understanding and knowledge of ongoing protocols and disease-related terminology for studies.
• Basic knowledge of drug development process.
• Ability to sit for prolonged periods; reach with arms and hands; lift and move small objects; use hands to keyboard and perform other office related tasks including repetitive movement of the wrists, hands and/or fingers.
• Occasional travel required, as needed.

Additional Requirements

• None