Clinical Research Coordinator

Also called: Clinical Data Coordinator, Clinical Manager, Clinical Program Coordinator, Clinical Program Manager, Clinical Project Manager

Varies

estimated salary

Clinical research coordinators 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.

 

 

  • 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, or 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, or 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, or 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.
  • Organize space for study equipment and supplies.
  • Develop advertising and other informational materials to be used in subject recruitment.
Work Context
  • Telephone — 99% responded "Every day".
  • Electronic Mail — 91% responded "Every day".
  • Contact With Others — 86% responded "Constant contact with others".
  • Face-to-Face Discussions — 72% responded "Every day".
  • Work With Work Group or Team — 66% responded "Extremely important".
  • Importance of Being Exact or Accurate — 52% responded "Extremely important".
  • Freedom to Make Decisions — 47% responded "A lot of freedom".
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Work Activities
  • Getting Information — Observing, receiving, and otherwise obtaining information from all relevant sources.
  • Establishing and Maintaining Interpersonal Relationships — Developing constructive and cooperative working relationships with others, and maintaining them over time.
  • Making Decisions and Solving Problems — Analyzing information and evaluating results to choose the best solution and solve problems.
  • Organizing, Planning, and Prioritizing Work — Developing specific goals and plans to prioritize, organize, and accomplish your work.
  • Updating and Using Relevant Knowledge — Keeping up-to-date technically and applying new knowledge to your job.
  • Communicating with Supervisors, Peers, or Subordinates — Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.
  • Documenting/Recording Information — Entering, transcribing, recording, storing, or maintaining information in written or electronic/magnetic form.
  • Processing Information — Compiling, coding, categorizing, calculating, tabulating, auditing, or verifying information or data.
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Detailed Work Activities
  • Promote products, services, or programs.
  • Maintain knowledge of current developments in area of expertise.
  • Conduct financial or regulatory audits.
  • Manage organizational or project budgets.
  • Interview employees, customers, or others to collect information.
  • Advise customers on technical or procedural issues.
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Knowledge

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.

Skills

Reading Comprehension
  • Understanding written sentences and paragraphs in work related documents.
Coordination
  • Adjusting actions in relation to others' actions.
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.
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Abilities

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.
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Personality

People interested in this work like activities that include ideas, thinking, and figuring things out.
They do well at jobs that need:
  • Achievement/Effort
  • Persistence
  • Initiative
  • Leadership
  • Cooperation
  • Concern for Others
  • Social Orientation
  • Self Control
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Technology

You might use software like this on the job:

Analytical or scientific software
  • IBM SPSS Statistics Hot Technology
  • SAS Hot Technology
  • Minitab Hot Technology
  • The MathWorks MATLAB Hot Technology
  • StataCorp Stata
  • Qualitative analysis software
  • Electronic data capture EDC software
  • InferMed MACRO Electronic Data Capture
Spreadsheet software
  • Microsoft Excel Hot Technology
Office suite software
  • Microsoft Office Hot Technology
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