The Clinical Trial Associate supports, coordinates, and implements clinical research projects under general supervision. Responsibilities include assisting with study start-up, maintaining study documentation, and ensuring compliance with clinical study standards.
Requirements summary
A bachelor's degree is required, along with a minimum of 3 years of industry-related work experience or an advanced degree with 1-2 years of relevant experience. Candidates should possess problem-solving abilities and a working knowledge of clinical drug development processes.
bachelor degreeInterpersonal SkillsTroubleshootingOrganizational SkillsCommunication SkillsAnalytical SkillsProblem SolvingVendor ManagementMedical TerminologyMicrosoft OfficeAttention to DetailData CollectionWriting SkillsFDA RegulationsGCP GuidelinesICH GuidelinesClinical Drug Development
Job description
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:
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
Education
Bachelor’s degree required
Experience
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
SKILLS
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
Physical Requirements
Incumbents generally must be able to, with or without accommodation, have the proficient use of both sensory perception/clarity and muscle control/coordination. This may include vision (near, far, color, glare control), hearing (auditory attention, sound localization), speech, strength, agility, dexterity flexibility, steadiness or reaction time.
The salary range for this position here noted is representative of a good faith estimate of all experience levels for this position. PROMETRIKA considers several factors when extending and offer, including but not limited to the role, the function and associated responsibilities, the candidate’s work experience, education/training background and parity with current employees in the same or similar positions.
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