Clinical Trials Associate Apprenticeships are designed to help to help life sciences companies better collect data and improve their reproducibility in research.
We use grants through our foundation to cover the costs of training and mentorship. This includes practical, on site instruction at a host company in areas such as clinical trial team support, collection of essential clinical trial documentation, maintenance and filing during a clinical study, assistance in the operational and logistical aspects of clinical trials. Complementary topics such as clinical trial oversight and support, trial master file oversight and support, laboratory and medical terminology, industry regulatory guidances and a recognized industry certification. Each apprenticeship opportunity includes two industry (e.g. SOCRA, RAPS, ASQ) certifications upon completion.
This 18-24 Month apprenticeship includes the goal of becoming an employee upon completion of program. If you are unable to directly hire the apprentice at the end they can be converted to a staffing arrangement or we can help them find a new position. Apprentices can be military veterans, students/recent graduates, mothers or fathers returning to the workforce or individuals coming off disability.
• Maintain required records of study activity including case report forms, drug dispensation records, or regulatory forms.
• Oversee subject enrollment to ensure that informed consent is properly obtained and documented.
• Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.
• Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.
• Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses.
• Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
• Identify protocol problems, inform investigators of problems, or assist in problem resolution efforts such as protocol revisions.
• Prepare study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
• Track enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts.
• Review proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks.
• Code, evaluate, or interpret collected study data.
• Participate in preparation and management of research budgets and monetary disbursements.
• Participate in the development of study protocols including guidelines for administration or data collection procedures.
• Instruct research staff in scientific and procedural aspects of studies including standards of care, informed consent procedures, or documentation procedures.
• Communicate with laboratories or investigators regarding laboratory findings.
• Review scientific literature, participate in continuing education activities, or attend conferences and seminars to maintain current knowledge of clinical studies affairs and issues.
• Order drugs or devices necessary for study completion.
• Confer with health care professionals to determine the best recruitment practices for studies.
• Collaborate with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions.
• Schedule subjects for appointments, procedures, or inpatient stays as required by study protocols. Perform specific protocol procedures such as interviewing subjects, taking vital signs, and performing electrocardiograms.
• Dispense medical devices or drugs, and calculate dosages and provide instructions as necessary.
• Maintain contact with sponsors to schedule and coordinate site visits or to answer questions about issues such as incomplete data.
• Inform patients or caregivers about study aspects and outcomes to be expected.
• Direct the requisition, collection, labeling, storage, or shipment of specimens.
• Register protocol patients with appropriate statistical centers as required.
• Interpret protocols and advise treating physicians on appropriate dosage modifications or treatment calculations based on patient characteristics.
• Arrange for research study sites and determine staff or equipment availability.
• Contact outside health care providers and communicate with subjects to obtain follow-up information.
• Contact industry representatives to ensure equipment and software specifications necessary for successful study completion.
• Solicit industry-sponsored trials through contacts and professional organizations.
• Organize space for study equipment and supplies.
• Develop advertising and other informational materials to be used in subject recruitment.
• Investigational Product Management
• Clinical Trial Protocol
• Subject Safety & Reporting
• Clinical Trial Management
• Clinical Trial Oversight
• Laboratory and Medical Terminology
Employers interested in Clinical Research Coordinator Apprenticeships should contact us using the form down below.
If you are interested in starting your career in one of our Clinical Research Coordinator Apprenticeships then submit your resume on our page for Prospective Apprentices.
Interested in working with us? Reach out below.