Clinical Research Analysts play an essential role in all forms of medical research including early and late phase clinical trials. They bring in their medical and scientific knowledge, analytical abilities, and research expertise to the job. Clinical research analysts works on medical research projects designed to evaluate the safety and efficiency of drugs, medical devices, or work towards understanding the biological processes in the human body.
Job Roles of Clinical Research Analyst:
The work arena of clinical research analysts is very wide, and the role can differ from company to company and from industry to the academia. Clinical research analysts work very closely with physician investigators or researchers who manage the clinical research. Clinical research analysts may also work close to the quality assurance department.
Job Responsibilities of Clinical Research Analyst:
- Coordinate and take part in clinical research studies performed by a supervising doctor to make sure that subject treatment offered by primary care staff and data obtained conform to study protocol; monitor subjects for inclusion in study based on pre-specified requirements; manage stock of unique drugs and materials required for study; offer basic patient care and treatment as requested by doctor.
- Acquire patient blood samples, cultures, tissues and other samples for laboratory study; begin drug orders and laboratory research for subjects dependent on standing protocol orders. Deliver direction and instruction to nursing team on methods for blending and providing new drugs and other types of patient care and treatment unique to the study being performed; manage interface with nursing and other specialized personnel to interpret protocol application for a given subjects and to answer queries about the research in progress.
- Consult with subjects and visiting medical professional to describe objective of study and get written consent for subjects to take part; describe diagnostic processes and method of therapy to lessen patient and family concern.
- Collect information and details from subject charts and records, patient meetings and other sources; assess and understand gathered data and prepare protocol conclusion forms, statistical reports and examines setting forth development, adverse trends and proper suggestions or conclusions.
- Consult with physician in establishing plans and protocols for clinical research studies and to discuss the interpretation of outcomes and the preparation of manuscripts for publication.
- Examine journals, abstracts and clinical literature to keep updated of new advancements and to get details pertaining to earlier studies to help in the planning of new studies.
Education and Training Required becoming a Clinical Research Analyst
To work as clinical research analyst, you will require at least an undergraduate degree in medical sciences, nursing or life sciences. It is highly suggested to have a graduate degree, as it can enable you to be eligible for more high level roles, a better pay grade and benefits over other job applicants.
Most companies look for trained professionals for clinical trial analyst position. Training usually consists of exposure to general procedural methods, in-depth knowledge regarding clinical research process, introduction to clinical research protocols, and guidelines established by various regulatory authorities to perform clinical trials. Enrolling in a clinical research training program to obtain formal certification is highly recommended.