Clinical Trial Associate I
About The Position
PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We’re driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the innovations we help bring to market. Our clients include national and international biopharmaceutical and medical device companies of all sizes. RESPONSIBILITIES Under general supervision, the Clinical Trial Associate (CTA) supports, coordinates, and implements clinical research projects. The CTA assists and works with the study team in the initiation, maintenance and closeout of clinical projects according to GCP, ICH, CFR and SOPs/WPDs. This position is an exempt position and will report directly into the Associate Manager, Clinical Operations. The CTA will have responsibilities assigned by the management and leadership team in Clinical Operations. The CTA:
Requirements
- Bachelor’s degree required
- Minimum of 3+ years’ industry related work experience or an advanced degree in a related field with a minimum of one (1) to two (2) years of relevant work experience
- Problem solving abilities, troubleshooting abilities and resourcefulness
- Analytical problem-solving experience, including excellent organizational skills and attention to detail
- Working knowledge of clinical drug development process as well as ICH, GCP guidelines, and US FDA regulations
- Effective communication and interpersonal skills; ability to build relationships internally and externally
- Familiarity with medical terms
- Demonstrated writing skills to deliver messages effectively so messages are clearly understood
- Demonstrated expertise with PCs and standard Microsoft Office software applications
Responsibilities
- Support the CTM or project manager with study start up and execution
- Act as a second point of contact between team members, vendors and study sites to assist with study conduct
- Follow established clinical study standards and procedures to plan and conduct clinical research studies
- Request, collect and submit site documents
- Review study start up documents and disseminate to the appropriate functional groups (i.e., legal, regulatory)
- Coordinate IRB/EC submissions and tracking progress to review and approval
- Track study start-up status
- Establish and maintain the study TMF with minimal guidance. Prepare master Clinical Study Files and Trial Master Files for archiving and/or transfer to a client
- Set up and maintain study clinical trial management system (CTMS)
- Assist in development of supportive study documents such as informed consent forms, monitoring templates, study subject tracking tools, study drug shipment and monitoring forms, study manuals and training materials, as required for a new clinical study
- Assist with and/or may play a lead role in the development of data collection tools and procedure manuals
- Work with Project Managers/ Clinical Trial Manager to develop status report templates in accordance with client specifications. Assist the Project Managers/ Clinical Trial Manager to compile status report data throughout the course of a study
- Assist with the tracking and compilation of enrollment information from sites
- Participate in tracking and reporting of study data for management reports
- Collate and distribute study related materials
- Collate and assemble study binders (regulatory, pharmacy, laboratory), study reference manuals and study data collection tools
- Assist with reviewing monitoring visit reports
- Accompany the CTM or CRA on site monitoring visits, if required
- May have site management responsibilities
- Assist with vendor management
- Apply knowledge of company policies and standard practices to resolve problems
- Maintain open communication channels with study sites and members of the study team to ensure proper study progress
- Analyze issues and use judgment to make decisions
- Escalate non-standard problems or issues as may be required
- Assist with and/or may play a lead role in the development of procedures and tools for data collection
- Assist with and/or may play a lead role in the development of study documents including informed consent forms, data collection tools and procedure manuals
- Perform other duties as required
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
