Certified Clinical Research Coordinators (CCRCs) are expected to have general knowledge of:
     • laboratory terminology, tests, and procedures
     • basic math, including adding, subtracting, multiplying, dividing, and calculating percentages
     As defined by the 2010 ACRP Job Analysis Survey, a Certified Clinical Research Coordinator (CCRC®) shall have proficiency in the following areas of clinical research:







        I. Investigational Product Management
        •  Ensure adequacy of investigational product and other supplies at site
        • Ensure randomization and emergency codes of investigational product have been maintained
        • Ensure proper storage, dispensing, handling, and disposition of investigational product and other supplies
        • Reconcile investigational product and other supplies
        • Maintain accountability of investigational product
        • Prepare investigational product according to the protocol
        • Dispense investigational product according to the protocol
        • Retrieve investigational product and calculate subject compliance
        • Maintain randomization and emergency codes of investigational product dispensing
        • Prepare emergency use report
        Using knowledge of:
        • Investigational product (e.g., package insert, report of prior investigations, Investigator's Brochure)
        • Investigational product inventory
        • Investigational product accountability
        • Investigational product storage
        • Packaging and labeling
        • Supplemental/rescue/comparator product
        • Investigational product compliance (e.g., protocol, standard operating procedures, local governance)
        • Accountability records
     II. Protocol
        • Evaluate protocol for feasibility
        • Evaluate congruence of data collection tools (e.g., case report form (CRF), electronic data capture (EDC) with the study protocol
        • Verify the eligibility of potential trial subjects
        • Contribute to protocol development
        • Coordinate protocol approval process
        • Review protocol for feasibility
        • Review protocol during Investigator’s meeting
        • Execute study per protocol
        • Recommend and Implement protocol amendments
        Using knowledge of:
        • Protocol development
        • Protocol submission and approval procedures
        • Clinical trial phase
        • Study design characteristics (e.g., double‐blind, crossover, randomized)
        • Study objective
        • Description of procedures
        • Amendment submission and approval procedures
        • Inclusion/exclusion criteria
        • Statistical plan
     III. Safety
        • Assess safety during trial participation
        • Minimize potential risks to subject safety
        • Oversee safety risks (e.g., clinical holds, product recalls)
        • Report required adverse events to regulatory authorities and/or IRB/IEC
        • Ensure adverse events reporting is documented (e.g., serious, severe, moderate, mild, expected, unexpected)
        • Ensure reasons for subject discontinuation are documented (i.e., causes, contact efforts)
        • Handle medical monitor oversight
        • Conduct study‐related procedures and monitor the safety of the trial subjects and investigational staff
        • Manage and motivate the investigational staff and other disciplines involved, and take measures to minimize any potential risks
        • Inform the sponsor and IRB/IEC of any changes to the protocol or safety concerns and submit progress reports to the IRB/IEC per requirements
        • Review common laboratory values and alerts
        • Determine and document the causality of adverse events
        • Identify expected or unexpected results associated with investigational products
        • Implement Investigator’s plan of action for management of adverse event (e.g., stop investigational product; call, retest, treat subject)
        • Maintain follow‐up to determine resolution of adverse event
        • Report serious adverse event to Sponsor/CRO and IRB/IEC
        • Classify adverse events (i.e., serious, severe, moderate, mild, expected, unexpected)
        • Record adverse event and relevant information on source document
        • Document reasons for subject discontinuation (i.e., causes, contact efforts)
        • Document follow‐up medical care for study subjects, as applicable
        • Conduct safety monitoring/reporting activities
        • Initiate un‐blinding procedures
        Using knowledge of:
        • Investigator’s Brochure
        • Safety monitoring
        • Safety and clinical databases
        • Subject safety issues (e.g., toxicity, significant lab values)
        • Adverse events reporting
        • Serious adverse events reporting
        • Safety reporting requirements
     IV. Trial Management
        • Verify investigator/site feasibility
        • Develop timelines for conducting and completing the clinical trial
        • Prepare and conduct initiation activities
        • Ensure appropriate training of the investigational staff
        • Develop a recruitment strategy and study management plan
        • Follow a recruitment strategy and study management plan
        • Schedule and coordinate pre‐study site visit
        • Identify minimum regulatory document requirements for site trial master file (e.g., country‐specific regulatory documents)
        • Ensure IRB/IEC review/approval of study and study documents
        • Facilitate site budget/contract approval process
        • Submit documents to regulatory authorities
        • Document and communicate site visit findings
        • Ensure clinical trial registry requirements are met
        • Ensure timely review of study data (e.g., laboratory results, x‐rays)
        • Maintain current vendor credentials (e.g., lab certification/licensure and normal ranges)
        • Prepare and conduct close‐out monitoring visit(s)
        • Prepare study summary and/or close‐out letter for IRB/IEC
        • Document protocol deviations/violations
        • Evaluate study for feasibility
        • Schedule subjects
        • Obtain informed consent and screen trial subjects
        • Prepare study documents for IRB/IEC and/or sponsor review/approval
        • Prepare study documentation (e.g., schedule of events, description of procedures)
        • Train site personnel on Sponsor/CRO and regulatory requirements for study conduct (e.g., protocol procedures, EDC)
        • Select the investigational staff and assign roles and responsibilities
        • Develop a recruitment strategy and site study management plan
        • Transmit CRFs to Data Management
        • Review CRF queries from Data Management
        • Coordinate study monitoring visits
        • Select and manage local vendors (e.g., laboratory, x‐ray, MRI)
        • Draft study specific tools (e.g., source document, tracking tools)
        • Obtain, negotiate, and seek approval of study budgets and clinical trial agreement
        • Conduct subject visits according to requirements
        • Implement corrective actions plans
        • Maintain trial master file (e.g., regulatory binder)
        • Communicate laboratory/diagnostic results with Principal Investigator and Sponsor/CRO
        • Maintain standards for handling hazardous goods (e.g., IATA)
        • Manage study supplies (e.g., lab kits, case report forms)
        • Maintain equipment (e.g., calibration and preventive maintenance)
        • Manage study record retention and availability
        • Manage financial agreements
        • Comply with subject privacy regulations
        • Prescreen telephone calls for eligibility requirements
        • Maintain subject screening/enrollment log
        • Collect, record, and report accurate and verifiable data
        • Manage study issues
        Using knowledge of:Site Activities
        • Contract budget negotiations and approval process
        • Monitoring guidelines/plan and tools
        • Disposition of unused study‐related materials (e.g., CRF at end of study, destruction of lab kits)
        • Equipment and supplies (e.g., x‐ray, computer, lab kits) and storage
        • Pre‐study site visit
        • Investigator's meeting
        • Site initiation
        • Monitoring visit
        • Close‐out visit
        • Site monitoring visit log
        • Site signature log
        • Delegation listing
        • Trial master file (e.g., site, sponsor)
        • Regulatory documents
        • Record retention
        • Visit reports (e.g., initiation, close‐out)
        • Final report
        • Progress reports
        Protocol Compliance
        • Project feasibility
        • Study project tools
        • Sample collection, shipment, and storage
        • Study management plan (e.g., timelines, data management)
        • Good Clinical Practice
        • Procedure manuals
        • Protocol deviations
        Subject Scheduling, Screening, Recruitment, and Retention
        • Project timelines
        • Recruitment plan/strategies
        • Subject compliance
        • Subject visit logistics
        • Subject selection, screening, and recruitment
        • Subject retention
        • Subject discontinuation
        • Clinical trial registry
        PI Oversight/Qualifications
        • Staff qualifications
        • Staff roles and responsibilities
        • Plan for staff oversight
        • Investigator qualifications/site selection (e.g., therapeutic area, education, experience)
        • Plan for ancillary staff education
        CRF/Source Documents
        • Data management activities
        • Communication documentation (e.g., telephone, email)
        • Data management plan
        • Data query resolution
        • Electronic data (e.g., electronic health records, electronic case report forms)
        • Case Report Form
        • Essential documentation, subject related and non‐subject related (e.g., past medical records, lab reports, protocol, IRB approvals)
        • Source documentation
        • Vulnerable subject populations
        • Communication with subjects
        • Protection of human subjects
        • Subject reimbursement
        • Subject privacy regulations
        • Informed consent
        • Indemnification/insurance
     V. Trial Oversight
        • Ensure consistency between the sites’ standard operation procedures (SOPs) and the study requirements
        • Ensure investigator/site protocol compliance
        • Facilitate investigator/site corrective actions
        • Ensure compliance with electronic data requirements (e.g., electronic health records, eCRF)
        • Ensure adequate site management
        • Prepare the study site for audits and inspections
        • Respond to or facilitate response to audit/inspection findings
        • Ensure proper collection, processing, and shipment of specimens (e.g., centrifuge, preparation of slides, freezing, refrigeration)
        • Ensure proper adverse event reporting by the investigator
        • Escalate problems to appropriate in‐house management
        • Investigate potential fraud and misconduct
        • Report potential fraud and misconduct
        • Ensure follow‐up medical care for study subjects is documented, as applicable
        • Ensure adequate consent and documentation
        • Ensure staff, facility, and equipment availability throughout the study
        • Ensure compliance with study requirements and regulations
        • Prepare for audits, inspections, and follow up
        • Ensure access to source data by authorized parties, in accordance with ICH‐GCP, and protect confidentiality by limiting unauthorized access
        • Ensure that IRB/IEC documentation is adequate and that details of the IRB/IEC composition are on file
        Using knowledge of:
        • Issues management (e.g., escalation)
        • Audit preparation
        • Regulatory standards
        • Audit documents
        • Project monitoring guidelines
        • Project investigator supervision requirements