Job Roles of CR Professionals
Clinical Research Associates: To monitor clinical trials, ensure compliance with the clinical trial protocol, checks clinical sites activities, make on-site visits, CRFs.
Clinical Research Investigators: Conduct BA/BE studies, writing / revising SOP, review of protocols, investigators brochures, ICF & CRFs Protocol, CRF & ICF preparations plans and conduct of BA/BEIEC/IRB affairs-GC.
Study Coordinators: Provides safety & protection while collecting & managing the study data.
Data Manager / Biostatistician: Design, study & predict the seriousness of the disease, seriousness of the disease, evaluate new treatment and effectiveness of medication, participate in research design, data collection, choosing & implementing appropriate methodologies, interpreting the results.
Regulatory Affairs Managers: Review & registration of documents, evaluation of technical data, liaison with regulatory authorities.
Clinical Trials Auditors: Conducts audits for regulatory function within the trial department to assure compliance with GLP/GCP in accordance with established FDA regulations and company policies & standard operating procedure.
Clinical Research Managers: Manage, supervise, train, mentor clinical research staff, approve investigator's study, budget & contract, review & approve regulatory documents, develop a protocol, approve CRFs, review study data.
Business Development Manager: Identify potential clients, establish business relations, responsible for meeting new clients, following up on leads, market research.
Drug Safety Associate: Manage & relay drug safety information, maintain current knowledge of global drug safety regulations, summarize clinical safety data, write narratives with medical input, report SADRs to Regulatory Authorities, participate in training on drug safety issues & another task under drug safety.
Medical Writer: Documentation, manuscripts, abstracts, external communication tools Clinical Data Manager: Ensures the accuracy & consistency of data prepared for regulatory bodies for reporting purpose.