Role Description

Scientific > Clinical Research Coordinator

Salary National Average

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66470.0000 72670.0000 79200.0000

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Short Description:

A Clinical Research Coordinator (CRC) manages the daily operations of clinical trials, ensuring that studies are conducted according to protocol, regulatory requirements, and ethical standards. Their duties include recruiting and screening study participants, obtaining informed consent, coordinating study visits, collecting and maintaining accurate trial data, and communicating with investigators and sponsors. CRCs are responsible for ensuring compliance with Good Clinical Practice (GCP) and handling regulatory documentation. Strong organizational, communication, and problem-solving skills are essential for success in this role, as Clinical Research Coordinators play a key role in the smooth execution and success of clinical trials.

Duties / Responsibilities:

  • 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 policies.
  • 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.

Skills / Requirements / Qualifications

  • Education: Bachelor’s degree in life sciences, nursing, public health, or a related field. Advanced degrees or certifications in clinical research are preferred (e.g., CCRC through ACRP).
  • Certification: Certified Clinical Research Coordinator (CCRC) certification may be preferred or required, demonstrating knowledge of clinical research standards.
  • Knowledge of Clinical Research Protocols: In-depth understanding of clinical trial processes, study protocols, and Good Clinical Practice (GCP) guidelines.
  • Organizational and Time Management Skills: Strong organizational abilities to manage multiple studies simultaneously, track patient participation, and maintain study documentation.
  • Attention to Detail: High attention to detail to ensure accurate documentation of patient data, informed consent, and adherence to regulatory requirements.
  • Communication and Interpersonal Skills: Excellent communication skills for interacting with patients, healthcare providers, and sponsors, and explaining complex study protocols to participants.
  • Familiarity with Regulatory Requirements: Knowledge of FDA regulations, Institutional Review Board (IRB) requirements, and other local, state, and federal regulations governing clinical trials.
  • Technical Skills: Proficiency with electronic data capture (EDC) systems, clinical trial management software (CTMS), and other tools used in clinical research coordination.

Job Zones

  • Title:  Job Zone Four: Considerable Preparation Needed
  • Education:  Most of these occupations require a four-year bachelor's degree, but some do not.
  • Related Experience:   Most of these occupations require a four-year bachelor's degree, but some do not.
  • Job Training:  Employees in these occupations usually need several years of work-related experience, on-the-job training, and/or vocational training.
  • Job Zone Examples:  Many of these occupations involve coordinating, supervising, managing, or training others. Examples include real estate brokers, sales managers, database administrators, graphic designers, chemists, art directors, and cost estimators.
  • SVP Range:  (7.0 to < 8.0)

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