Clinical Research Specialist 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.

*A job as a Clinical Research Specialist falls under the broader career category of Clinical Research Coordinators. The information on this page will generally apply to all careers in this category. We are still seeking more specific information about this career from experts in this field. If you can provide us with more information, .

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Clinical Research Specialist Career

What Clinical Research Specialists do:

  • Track enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts.
  • Review scientific literature, participate in continuing education activities, or attend conferences and seminars to maintain current knowledge of clinical studies affairs and issues.
  • 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.
  • Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.
  • Confer with health care professionals to determine the best recruitment practices for studies.
  • 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.
  • Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
  • Participate in preparation and management of research budgets and monetary disbursements.
  • 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.
  • Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.
  • Participate in the development of study protocols including guidelines for administration or data collection procedures.
  • Order drugs or devices necessary for study completion.
  • Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses.
  • Oversee subject enrollment to ensure that informed consent is properly obtained and documented.
  • Collaborate with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions.
  • Maintain required records of study activity including case report forms, drug dispensation records, or regulatory forms.
  • Develop advertising and other informational materials to be used in subject recruitment.
  • Arrange for research study sites and determine staff or equipment availability.
  • Direct the requisition, collection, labeling, storage, or shipment of specimens.
  • Contact outside health care providers and communicate with subjects to obtain follow-up information.
  • Organize space for study equipment and supplies.
  • 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.
  • 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.
  • Schedule subjects for appointments, procedures, or inpatient stays as required by study protocols.
  • Contact industry representatives to ensure equipment and software specifications necessary for successful study completion.
  • Interpret protocols and advise treating physicians on appropriate dosage modifications or treatment calculations based on patient characteristics.
  • Solicit industry-sponsored trials through contacts and professional organizations.
  • Register protocol patients with appropriate statistical centers as required.

What work activities are most important?

Importance 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.

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

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

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.

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

Communicating with Persons Outside 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.

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

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

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

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

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

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

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

Guiding, Directing, and Motivating Subordinates - Providing guidance and direction to subordinates, including setting performance standards and monitoring performance.

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

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

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

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

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

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.

Provide Consultation and Advice to Others - Providing guidance and expert advice to management or other groups on technical, systems-, or process-related topics.

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

Staffing Organizational Units - Recruiting, interviewing, selecting, hiring, and promoting employees in an organization.

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.

Holland Code Chart for a Clinical Research Specialist