The Clinical Trial Specialist works in Public or Private Clinical Research Organisations, generally in Pharmaceutical or Biotechnology Industries. They are part of a multi-disciplinary team focused on the delivery and execution of Phase I-IV clinical trials in humans. They are mainly office-based but travel to sites (hospitals, pharmacology units and General Practitioners) to conduct monitoring activities. Clinical Trial Specialists work initially with significant oversight as required by external regulations but over time gain increasing autonomy to monitor and deliver clinical trials consistently to the right quality and within budget. Typical job roles may include: Clinical Trials Assistant/Administrator, Clinical Research Associate and Study Coordinator with development to Clinical Project Manager.
The main duties and tasks of a Clinical Trials Specialist are:
Act as site Monitor on assigned studies. Conduct all stages of site management from set up through to close out, develop recruitment strategies and conduct Source Document Verification (SDV). This process ensures that the record of activity and data at a site are consistent with data collection systems.
Produce high quality documentation to include site monitoring visit reports, site agreements, risk based monitoring plans, meeting minutes, risk/mitigation and action logs and effective presentations.
File study documentation to the Trial Master File (TMF) consistent with company SOPs and regulatory guidelines. Maintain all documentation per current quality standards. Participate in TMF and site audits as requested.
Provide support to Clinical Project Managers e.g. produce reports on data quality, track equipment distribution and return, follow up delayed sample shipments, generate consulting/ confidentiality agreements., liaise with Clinical Research Associates (CRAs) and external contractors
Maintain study tracking systems, e.g. eClinical Trial Management Systems (eCTMS), finance and budget management systems, eCase Report Form (eCRF) and trial status reports. Summary of Standard https://www.instituteforapprenticeships.org/apprenticeship-standards/clinical-trials-specialist-degree/ Full Standard https://www.instituteforapprenticeships.org/media/3760/clinical_trial_specialist_degree.pdf
