{"schemaVersion":"1.0","exportedAt":"2026-05-15T11:13:41.946Z","occupation":{"soc":"11-9121.01","title":"Clinical Research Coordinators","group":"Management","sector":"54","jobZone":4,"jobZoneInferred":false},"framework":{"version":"v.26.05","description":"","contextCovered":"This 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.","levels":{"emerging":{"label":"Emerging","statements":["Subject scheduling and appointment coordination — execute under direct supervision using study protocol guidelines at a clinical research site.","Protocol procedures such as vital sign measurement — perform with oversight from senior coordinators during initial subject visits in a supervised research environment.","Eligibility screening interviews — conduct using structured scripts and pre-defined inclusion and exclusion criteria under investigator direction.","Informed consent documentation — assist in obtaining and filing with attention to required signatures and timestamps under the guidance of an experienced coordinator.","Protocol worksheets and procedural manuals — prepare draft versions using office suite and word-processing software under supervisory review.","Medical records and subject histories — review for relevant eligibility data by following standardized checklists provided by the study team.","Adverse event data — enter and track in database software under close supervision, flagging discrepancies for investigator review.","Study compliance requirements — recognize and apply basic local and federal regulatory standards when assisting with routine monitoring tasks.","Patient and caregiver communications — deliver scripted information about study procedures and expected outcomes under coordinator supervision at a clinical site.","Electrocardiogram and other protocol-specified procedures — perform following step-by-step instructions after completion of required training at an accredited research facility."]},"developing":{"label":"Developing","statements":["Subject enrollment schedules — manage independently across multiple concurrent study visits by coordinating with clinical staff using project management and scheduling software.","Protocol-specified clinical procedures including vital signs and ECGs — conduct routinely with minimal oversight, ensuring procedural accuracy and documentation integrity.","Eligibility assessments — execute through combined screening interviews, medical record reviews, and physician consultations, applying protocol criteria with growing confidence.","Adverse event and side effect reports — compile, document, and submit to oversight agencies in accordance with IRB and regulatory requirements under general investigator guidance.","Institutional review board documents and progress reports — draft and finalize using standardized templates and office suite software within established submission timelines.","Informed consent processes — oversee end-to-end for assigned protocols, verifying that consent is properly obtained, explained, and documented for each enrolled subject.","Regulatory and institutional compliance — monitor day-to-day study activities against protocol requirements, identifying deviations and escalating issues to the principal investigator.","Data integrity in clinical databases — maintain by performing routine data queries, reconciliation checks, and quality reviews using database and analytical software tools.","Study team coordination — facilitate communication among investigators, nurses, and laboratory staff using electronic mail and video conferencing software in a multi-site research environment.","Patient and caregiver education — deliver tailored explanations of study aspects and anticipated outcomes, applying active listening and social perceptiveness to address individual concerns."]},"proficient":{"label":"Proficient","statements":["Full-scope subject enrollment management — direct across complex, multi-phase clinical trials by applying independent judgment to evaluate eligibility and resolve protocol ambiguities.","Non-routine protocol procedures and deviations — assess, document, and resolve autonomously by applying critical thinking and consulting regulatory guidance as appropriate.","Comprehensive adverse event oversight — evaluate severity and causality, prepare detailed reports, and lead communications with regulatory and oversight agencies without direct supervision.","Protocol compliance monitoring — conduct thorough audits of all study activities against local, federal, and state requirements, identifying systemic risks and implementing corrective actions.","Complex IRB submissions and amendments — author independently, integrating clinical, administrative, and regulatory knowledge to meet submission standards at a research institution.","Informed consent quality assurance — evaluate and refine consent processes across an entire study portfolio, ensuring ethical standards and regulatory compliance are consistently upheld.","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.","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.","Protocol feasibility and risk assessment — evaluate new study proposals against site capabilities and regulatory constraints, providing evidence-based recommendations to investigators.","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":{"label":"Advanced","statements":["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.","Regulatory and compliance infrastructure — establish site-wide standard operating procedures and quality management systems to ensure sustained adherence to FDA, ICH, and IRB standards.","Principal investigator and sponsor relationships — cultivate and manage at a strategic level, representing the organization's clinical research capabilities in contract and protocol negotiations.","Workforce development programs — design and implement competency-based career pathways and mentorship structures for clinical research coordinators and junior staff across the organization.","Multi-site trial oversight — lead coordination across geographically distributed research sites by deploying project management software and governance frameworks to ensure protocol fidelity.","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.","Budget and resource management — direct financial planning for clinical research operations, overseeing accounting software-driven cost tracking, sponsor invoicing, and budget variance resolution.","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.","Knowledge translation and scientific dissemination — lead preparation of manuscripts, conference presentations, and regulatory submissions that communicate trial outcomes to scientific and policy audiences.","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."]}}},"sources":{"onet":"v30.2 (CC BY 4.0)","crosswalk":"https://skillscrosswalk.com","generator":"LER.me"},"attribution":"© EBSCOed"}