Clinical trials specialist (degree) (level 6)
Working as part of a multi-disciplinary team focusing on the delivery and execution of Phase I-IV clinical trials in humans.
- Qualification level
Equivalent to degree.
- Typical duration
- 60 months
- Apprenticeship category
- Health and science
- Maximum funding
Maximum amount government will fund
for apprenticeship training.
- Also known as
- Clinical Research Associate
- Clinical Trials Assistant/Administrator
- Study Coordinator with development to Clinical Project Manager
Skills an apprentice will learn
- Monitor and Source Document Verification Develop, write and implement centralised and site monitoring plans. Conduct SDV and implement recruitment strategies for clinical trials. Assess suitability of trials at sites based on detailed understanding of protocol requirements and create appropriate feasibility questionnaires at country and site level. Conduct all site monitoring activities: site selection, initiation, maintenance and close out per national and local requirements. Record and report compliance deviations such as Serious Breaches and Product Complaints. Utilise information from clinical systems to oversee accuracy and contemporariness of trial data.
- Clinical Trial Management Systems Use clinical trial systems including; electronic Clinical Trial Management Systems (eCTMS), electronic Case Report Forms (eCRF), Interactive Response Technology (IRT), electronic Patient/Physician Reported Outcomes systems and electronic Trial Master Files (eTMF). Develop documentation to support set up, programming, maintenance and oversight of these systems to be to be compliant with the protocol and Good Clinical Practice.
- Project Management and Leadership: Generate effective project plans to include management of scope, schedules, and risk. Organise resources, tasks and people. Co-ordinate team activities to meet project requirements and quality processes. Adapt clinical strategy/delivery to be consistent with variations in national, local and Ethics Committee requirements when conducting trials across multiple regions/countries.
- Data Collection and Reporting: Input into the development of data management documentation, including design of Case Report Forms, Data Management Plans, Data Review Plans, edit checks and User Acceptance Testing Plans.
- Communication Skills: Write extended reports and critique others' work across a range of documentation, e.g. protocols, consent forms and clinical study reports. Deliver oral presentations and answer questions about their work and/or the work of their team. Utilise interpersonal skills, communication and assertiveness to persuade and motivate.
- Critical Thinking: Conceptualise, evaluate and analyse information to solve problems.
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