NSXNational Skills ExchangeSign in
Back to Framework

Clinical Research Coordinators

SOC 11-9121.01Job Zone 4 · Considerable Preparationv.26.05

Context coveredThis framework covers clinical research coordination practice in academic medical centers, contract research organizations, and industry-sponsored trial sites, spanning subject enrollment, protocol execution, regulatory compliance, and organizational research leadership.

Sources:O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.SkillsCrosswalkSkillsCrosswalk — O*NET enrichment + adjacency index. Opens in new tab.
Emerging
Entry / Apprentice
  1. Subject scheduling and appointment coordination — execute under direct supervision using study protocol guidelines at a clinical research site.
  2. Protocol procedures such as vital sign measurement — perform with oversight from senior coordinators during initial subject visits in a supervised research environment.
  3. Eligibility screening interviews — conduct using structured scripts and pre-defined inclusion and exclusion criteria under investigator direction.
  4. Informed consent documentation — assist in obtaining and filing with attention to required signatures and timestamps under the guidance of an experienced coordinator.
  5. Protocol worksheets and procedural manuals — prepare draft versions using office suite and word-processing software under supervisory review.
  6. Medical records and subject histories — review for relevant eligibility data by following standardized checklists provided by the study team.
  7. Adverse event data — enter and track in database software under close supervision, flagging discrepancies for investigator review.
  8. Study compliance requirements — recognize and apply basic local and federal regulatory standards when assisting with routine monitoring tasks.
  9. Patient and caregiver communications — deliver scripted information about study procedures and expected outcomes under coordinator supervision at a clinical site.
  10. Electrocardiogram and other protocol-specified procedures — perform following step-by-step instructions after completion of required training at an accredited research facility.
Developing
Mid-level / Established
  1. Subject enrollment schedules — manage independently across multiple concurrent study visits by coordinating with clinical staff using project management and scheduling software.
  2. Protocol-specified clinical procedures including vital signs and ECGs — conduct routinely with minimal oversight, ensuring procedural accuracy and documentation integrity.
  3. Eligibility assessments — execute through combined screening interviews, medical record reviews, and physician consultations, applying protocol criteria with growing confidence.
  4. Adverse event and side effect reports — compile, document, and submit to oversight agencies in accordance with IRB and regulatory requirements under general investigator guidance.
  5. Institutional review board documents and progress reports — draft and finalize using standardized templates and office suite software within established submission timelines.
  6. Informed consent processes — oversee end-to-end for assigned protocols, verifying that consent is properly obtained, explained, and documented for each enrolled subject.
  7. Regulatory and institutional compliance — monitor day-to-day study activities against protocol requirements, identifying deviations and escalating issues to the principal investigator.
  8. Data integrity in clinical databases — maintain by performing routine data queries, reconciliation checks, and quality reviews using database and analytical software tools.
  9. Study team coordination — facilitate communication among investigators, nurses, and laboratory staff using electronic mail and video conferencing software in a multi-site research environment.
  10. Patient and caregiver education — deliver tailored explanations of study aspects and anticipated outcomes, applying active listening and social perceptiveness to address individual concerns.
Proficient
Senior / Expert IC
  1. Full-scope subject enrollment management — direct across complex, multi-phase clinical trials by applying independent judgment to evaluate eligibility and resolve protocol ambiguities.
  2. Non-routine protocol procedures and deviations — assess, document, and resolve autonomously by applying critical thinking and consulting regulatory guidance as appropriate.
  3. Comprehensive adverse event oversight — evaluate severity and causality, prepare detailed reports, and lead communications with regulatory and oversight agencies without direct supervision.
  4. Protocol compliance monitoring — conduct thorough audits of all study activities against local, federal, and state requirements, identifying systemic risks and implementing corrective actions.
  5. Complex IRB submissions and amendments — author independently, integrating clinical, administrative, and regulatory knowledge to meet submission standards at a research institution.
  6. Informed consent quality assurance — evaluate and refine consent processes across an entire study portfolio, ensuring ethical standards and regulatory compliance are consistently upheld.
  7. Cross-functional study team leadership — coordinate investigators, clinical staff, sponsors, and external vendors across the full trial lifecycle in a large academic or industry research setting.
  8. Data analysis and study progress reporting — synthesize trial data using analytical and spreadsheet software to produce accurate status reports for sponsors, IRBs, and executive leadership.
  9. Protocol feasibility and risk assessment — evaluate new study proposals against site capabilities and regulatory constraints, providing evidence-based recommendations to investigators.
  10. Staff training and competency verification — design and deliver protocol-specific training using instructional strategies and learning frameworks tailored to diverse clinical research team members.
Advanced
Lead / Principal / Executive
  1. Organizational research strategy — set priorities and resource allocation across a portfolio of clinical trials, aligning site capabilities with sponsor and regulatory expectations at an enterprise level.
  2. Regulatory and compliance infrastructure — establish site-wide standard operating procedures and quality management systems to ensure sustained adherence to FDA, ICH, and IRB standards.
  3. Principal investigator and sponsor relationships — cultivate and manage at a strategic level, representing the organization's clinical research capabilities in contract and protocol negotiations.
  4. Workforce development programs — design and implement competency-based career pathways and mentorship structures for clinical research coordinators and junior staff across the organization.
  5. Multi-site trial oversight — lead coordination across geographically distributed research sites by deploying project management software and governance frameworks to ensure protocol fidelity.
  6. Adverse event reporting and safety governance — chair or advise data safety monitoring boards and safety review committees, providing expert judgment on risk–benefit assessments at the study-portfolio level.
  7. Budget and resource management — direct financial planning for clinical research operations, overseeing accounting software-driven cost tracking, sponsor invoicing, and budget variance resolution.
  8. Institutional research policy development — author and champion policies governing human subjects protection, data integrity, and research ethics across the institution in collaboration with IRB and legal counsel.
  9. Knowledge translation and scientific dissemination — lead preparation of manuscripts, conference presentations, and regulatory submissions that communicate trial outcomes to scientific and policy audiences.
  10. Organizational learning and continuous improvement — model and institutionalize evidence-based best practices in research coordination by applying active learning principles and performance metrics to drive systemic quality improvement.

AI-at-Work Competency Framework

Sources:Anthropic Economic IndexAnthropic Economic Index — release_2026_03_24. Opens in new tab.Jadhav & Danve, 2026Skill Automation Feasibility Index — Jadhav & Danve, 2026 (arXiv:2604.06906). Opens in new tab.WEF Skills TaxonomyWEF Skills Taxonomy 2021 — Building a Common Language for Skills at Work. Opens in new tab.

A 4-level framework describing how a worker at each mastery level uses, directs, and evaluates AI tools in this occupation. Each statement cites its evidence inline. Subscribe for $19.99/mo to read the full framework — or sign in if you have a subscription.

  1. Emerging
  2. Developing
  3. Proficient
  4. Advanced
Monthly subscription · Stripe-hosted · unlocks AI-at-Work and Pathsmith™ Durable Skills across the full library

Pathsmith™ Durable Skills Framework

Sources:Pathsmith™ Durable SkillsPathsmith™ Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Subscriber feature

Ten durable-skill domains mapped to four proficiency levels for this occupation. Subscribe to unlock the full Pathsmith™ Durable Skills Framework across all 1,016 occupations.

Monthly subscription · Stripe-hosted · unlocks AI-at-Work and Pathsmith™ Durable Skills across the full library
Show O*NET source anchors56 anchors · skillscrosswalk.com

O*NET enrichment · skillscrosswalk.com

Suggest an O*NET correction

Source anchors that ground each statement

Related titles
Clinical Coordinator · Clinical Data Coordinator · Clinical Manager · Clinical Program Coordinator · Clinical Program Manager · Clinical Project Manager · Clinical Research Administrator · Clinical Research Coordinator · Clinical Research Director · Clinical Research Manager · Clinical Research Monitor · Clinical Research Nurse Coordinator
RAPIDS apprenticeships
—
O*NET skills
Reading ComprehensionActive ListeningWritingCoordinationSpeakingCritical ThinkingSocial PerceptivenessComplex Problem SolvingJudgment and Decision MakingMonitoringTime ManagementManagement of Personnel ResourcesActive LearningInstructingLearning StrategiesSciencePersuasionService Orientation
Knowledge domains
Customer and Personal ServiceEnglish LanguageAdministrativeMedicine and Dentistry
Abilities
Deductive ReasoningProblem SensitivityWritten ExpressionOral ExpressionWritten ComprehensionOral ComprehensionInductive ReasoningInformation OrderingSpeech RecognitionSpeech Clarity
Work styles
Attention to DetailDependabilityIntegrityCautiousnessCooperationIntellectual Curiosity
Technology
Data base user interface and query softwareAccounting softwareCategorization or classification softwareAnalytical or scientific softwareVideo conferencing softwareSpreadsheet softwareOffice suite softwareElectronic mail softwarePresentation softwareProject management software
Tasks · seed anchors for statements
  1. Schedule subjects for appointments, procedures, or inpatient stays as required by study protocols.
  2. Perform specific protocol procedures such as interviewing subjects, taking vital signs, and performing electrocardiograms.
  3. Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, or discussions with physicians and nurses.
  4. Prepare study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.
  5. Inform patients or caregivers about study aspects and outcomes to be expected.
  6. Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.
  7. Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.
  8. Oversee subject enrollment to ensure that informed consent is properly obtained and documented.
CIP education codes
14.120114.370126.010126.020226.020326.020426.020526.020626.020726.020826.020926.021026.029926.030126.030526.030726.039926.040126.040326.040626.049926.050226.050326.050426.050526.050726.050826.059926.070126.070226.070726.079926.080226.080426.080526.080726.089926.091026.091226.100126.100426.110126.110226.110426.119926.120126.130126.130226.130326.131026.131126.139926.140126.150126.150226.150326.150426.159926.999927.010127.010227.010327.010427.010527.019927.030127.030327.030427.030527.030627.039927.050127.050327.059927.060127.999930.010130.080130.100130.150130.180130.190130.250130.259930.270130.300130.320130.330130.340130.350130.380130.410130.430130.440130.490130.500130.700130.709938.010240.010140.020140.020240.020340.029940.040140.040240.040340.040440.049940.050140.050240.050340.050440.050640.050740.050840.050940.051040.051140.051240.059940.060140.060240.060340.060440.060540.060640.060740.069940.080140.080240.080440.080540.080640.080740.080840.080940.081040.089940.100240.109940.110140.999951.140151.200652.021052.021452.021654.0104

Sources: O*NET v30.2 (CC BY 4.0), SkillsCrosswalk.com, LER.me®, Anthropic Economic Index, SAFI (Jadhav & Danve, 2026), WEF Skills Taxonomy 2021, Pathsmith™ Durable Skills Framework. © 2026 EBSCOed.