Clinical Research Coordinator Career

Job 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.


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Clinical Research Coordinator Career

What Clinical Research Coordinators do:

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

What work activities are most important?

Importance Activities

Documenting/Recording Information - Entering, transcribing, recording, storing, or maintaining information in written or electronic/magnetic form.

Organizing, Planning, and Prioritizing Work - Developing specific goals and plans to prioritize, organize, and accomplish your work.

Working with Computers - Using computers and computer systems (including hardware and software) to program, write software, set up functions, enter data, or process information.

Getting Information - Observing, receiving, and otherwise obtaining information from all relevant sources.

Communicating with Supervisors, Peers, or Subordinates - Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.

Monitoring Processes, Materials, or Surroundings - Monitoring and reviewing information from materials, events, or the environment, to detect or assess problems.

Evaluating Information to Determine Compliance with Standards - Using relevant information and individual judgment to determine whether events or processes comply with laws, regulations, or standards.

Scheduling Work and Activities - Scheduling events, programs, and activities, as well as the work of others.

Performing Administrative Activities - Performing day-to-day administrative tasks such as maintaining information files and processing paperwork.

Establishing and Maintaining Interpersonal Relationships - Developing constructive and cooperative working relationships with others, and maintaining them over time.

Identifying Objects, Actions, and Events - Identifying information by categorizing, estimating, recognizing differences or similarities, and detecting changes in circumstances or events.

Making Decisions and Solving Problems - Analyzing information and evaluating results to choose the best solution and solve problems.

Training and Teaching Others - Identifying the educational needs of others, developing formal educational or training programs or classes, and teaching or instructing others.

Assisting and Caring for Others - Providing personal assistance, medical attention, emotional support, or other personal care to others such as coworkers, customers, or patients.

Processing Information - Compiling, coding, categorizing, calculating, tabulating, auditing, or verifying information or data.

Analyzing Data or Information - Identifying the underlying principles, reasons, or facts of information by breaking down information or data into separate parts.

Updating and Using Relevant Knowledge - Keeping up-to-date technically and applying new knowledge to your job.

Coordinating the Work and Activities of Others - Getting members of a group to work together to accomplish tasks.

Performing for or Working Directly with the Public - Performing for people or dealing directly with the public. This includes serving customers in restaurants and stores, and receiving clients or guests.

Judging the Qualities of Objects, Services, or People - Assessing the value, importance, or quality of things or people.

Thinking Creatively - Developing, designing, or creating new applications, ideas, relationships, systems, or products, including artistic contributions.

Communicating with People Outside the Organization - Communicating with people outside the organization, representing the organization to customers, the public, government, and other external sources. This information can be exchanged in person, in writing, or by telephone or e-mail.

Interpreting the Meaning of Information for Others - Translating or explaining what information means and how it can be used.

Coaching and Developing Others - Identifying the developmental needs of others and coaching, mentoring, or otherwise helping others to improve their knowledge or skills.

Inspecting Equipment, Structures, or Materials - Inspecting equipment, structures, or materials to identify the cause of errors or other problems or defects.

Developing Objectives and Strategies - Establishing long-range objectives and specifying the strategies and actions to achieve them.

Estimating the Quantifiable Characteristics of Products, Events, or Information - Estimating sizes, distances, and quantities; or determining time, costs, resources, or materials needed to perform a work activity.

Monitoring and Controlling Resources - Monitoring and controlling resources and overseeing the spending of money.

Developing and Building Teams - Encouraging and building mutual trust, respect, and cooperation among team members.

Performing General Physical Activities - Performing physical activities that require considerable use of your arms and legs and moving your whole body, such as climbing, lifting, balancing, walking, stooping, and handling materials.

Handling and Moving Objects - Using hands and arms in handling, installing, positioning, and moving materials, and manipulating things.

Resolving Conflicts and Negotiating with Others - Handling complaints, settling disputes, and resolving grievances and conflicts, or otherwise negotiating with others.

Holland Code Chart for a Clinical Research Coordinator