They work in a variety of employment settings, including hospitals, universities, and pharmaceutical labs. Safety precautions must be followed and protective gear used when dealing with potentially infectious samples.
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Career Roles & Responsibilities
- Take part in preparation and control of research budgets and financial payments.
- Notify subjects regarding all study aspects relevant to them.
- Enter study data into the applicable database.
- Keep track of study activities to make sure compliance with protocols and with all related local, state, and national regulatory and institutional polices.
- Manage necessary records of study related activity which includes case report forms, drug dispensation records etc.
- Communicate with laboratories or researchers about laboratory findings.
- Obtain industry-sponsored studies via personal contacts and professional organizations.
- Direct the request, collection, labelling, storage, or shipment of samples.
- Take part in meetings and seminars to update knowledge of clinical research and related issues.
- Enrol subjects in the study as per the study protocol.
- Prepare or get involved in quality assurance audits performed by study sponsors, regulatory authorities, or exclusively designated review groups.
- Prepare advertising and other educational materials and conduct campaigns to enroll subjects.
- Consult with health care experts to figure out the best recruitment practices for clinical trials.
- Arrange space for study equipment and other trial related material.
- Monitor enrolment status of participants and record dropout details such as dropout causes and subject contact efforts.
- Overview proposed study protocols to assess factors such as sample collection procedures, data management issues, and possible subject threats.
- Record adverse event and side effect information and consult with investigators concerning the reporting of events to regulatory agencies.
- Prepare trial-related paperwork such as protocol worksheets, adverse event reports, IRB documents, procedural manuals, and progress reports.
- Manage subject registration to make sure that informed consent is effectively obtained and recorded.
- Keep in touch with sponsors to schedule and coordinate site visits or to answer queries.
- Dispense study medical devices or drugs to subjects, determine dosages and deliver instructions as necessary.