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Career Description

Plan, direct, or coordinate clinical research projects. Direct the activities of workers engaged in clinical research projects to ensure compliance with protocols and overall clinical objectives. May evaluate and analyze clinical data.

What Job Titles Clinical Research Coordinators Might Have

• Clinical Research Administrator
• Clinical Program Manager
• Clinical Research Associate (CRA)
• Clinical Research Coordinator
• Clinical Trial Manager

What Clinical Research Coordinators Do

• Maintain required records of study activity including case report forms, drug dispensation records, or regulatory forms.
• Oversee subject enrollment to ensure that informed consent is properly obtained and documented.
• Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.
• Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.
• Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses.
• Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
• Identify protocol problems, inform investigators of problems, or assist in problem resolution efforts such as protocol revisions.
• Prepare study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
• Track enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts.
• Review proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks.
• Code, evaluate, or interpret collected study data.
• Participate in preparation and management of research budgets and monetary disbursements.
• Participate in the development of study protocols including guidelines for administration or data collection procedures.
• Instruct research staff in scientific and procedural aspects of studies including standards of care, informed consent procedures, or documentation procedures.
• Communicate with laboratories or investigators regarding laboratory findings.
• Review scientific literature, participate in continuing education activities, or attend conferences and seminars to maintain current knowledge of clinical studies affairs and issues.
• Order drugs or devices necessary for study completion.
• Confer with health care professionals to determine the best recruitment practices for studies.
• Collaborate with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions.
• Schedule subjects for appointments, procedures, or inpatient stays as required by study protocols.
• Perform specific protocol procedures such as interviewing subjects, taking vital signs, and performing electrocardiograms.
• Dispense medical devices or drugs, and calculate dosages and provide instructions as necessary.
• Maintain contact with sponsors to schedule and coordinate site visits or to answer questions about issues such as incomplete data.
• Inform patients or caregivers about study aspects and outcomes to be expected.
• Direct the requisition, collection, labeling, storage, or shipment of specimens.
• Register protocol patients with appropriate statistical centers as required.
• Interpret protocols and advise treating physicians on appropriate dosage modifications or treatment calculations based on patient characteristics.
• Arrange for research study sites and determine staff or equipment availability.
• Contact outside health care providers and communicate with subjects to obtain follow-up information.
• Contact industry representatives to ensure equipment and software specifications necessary for successful study completion.
• Solicit industry-sponsored trials through contacts and professional organizations.

What Clinical Research Coordinators Should Be Good At

• Oral Comprehension - The ability to listen to and understand information and ideas presented through spoken words and sentences.
• Written Comprehension - The ability to read and understand information and ideas presented in writing.
• Oral Expression - The ability to communicate information and ideas in speaking so others will understand.
• Written Expression - The ability to communicate information and ideas in writing so others will understand.
• Deductive Reasoning - The ability to apply general rules to specific problems to produce answers that make sense.
• Inductive Reasoning - The ability to combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events).
• Problem Sensitivity - The ability to tell when something is wrong or is likely to go wrong. It does not involve solving the problem, only recognizing there is a problem.
• Near Vision - The ability to see details at close range (within a few feet of the observer).
• Speech Clarity - The ability to speak clearly so others can understand you.
• Information Ordering - The ability to arrange things or actions in a certain order or pattern according to a specific rule or set of rules (e.g., patterns of numbers, letters, words, pictures, mathematical operations).

What Clinical Research Coordinators Should Be Interested In

• Investigative - Investigative occupations frequently involve working with ideas, and require an extensive amount of thinking. These occupations can involve searching for facts and figuring out problems mentally.

What Clinical Research Coordinators Need to Learn

• Medicine and Dentistry - Knowledge of the information and techniques needed to diagnose and treat human injuries, diseases, and deformities. This includes symptoms, treatment alternatives, drug properties and interactions, and preventive health-care measures.
• English Language - Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
• Administration and Management - Knowledge of business and management principles involved in strategic planning, resource allocation, human resources modeling, leadership technique, production methods, and coordination of people and resources.