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About the Job
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.
It is also Called
- Clinical Data Coordinator
- Clinical Operations Specialist
- Clinical Program Coordinator
- Clinical Program Manager
- Clinical Project Manager
- Clinical Research Administrator
- Clinical Research Associate (CRA)
- Clinical Research Coordinator
- Clinical Research Director
- Clinical Research Manager
What They 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.
Interests
People who work in this occupation generally have the interest code: EIC.
This means people who work in this occupation generally have Enterprising interests, but also prefer Investigative and Conventional environments.
Work Values
People who work in this occupation generally prize Independence, but also value Achievement and Working Conditions in their jobs.
Things They Need to Know
- 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.
- Mathematics - Knowledge of arithmetic, algebra, geometry, calculus, statistics, and their applications.
- Clerical - Knowledge of administrative and clerical procedures and systems such as word processing, managing files and records, stenography and transcription, designing forms, and other office procedures and terminology.
Things They Need to Be Able to Do
- Writing - Communicating effectively in writing as appropriate for the needs of the audience.
- Active Listening - Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.
- Coordination - Adjusting actions in relation to others' actions.
- Reading Comprehension - Understanding written sentences and paragraphs in work related documents.
- Speaking - Talking to others to convey information effectively.
- Critical Thinking - Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
- Monitoring - Monitoring/Assessing performance of yourself, other individuals, or organizations to make improvements or take corrective action.
Education Required
Most of these occupations require a four-year bachelor's degree, but some do not.
Wages
In 2012, the average annual wage in United States was $130,400.00 with most people making between $65,040.00 and n/a
Outlook
During 2010, this occupation employed approximately 49,000 people in United States. It is projected that there will be 53,000 employed in 2020.
This occupation will have about 0 openings due to growth and about 33,000 replacement openings for approximately 33,000 total annual openings.
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