CLINICAL RESEARCH COORDINATOR
CLINICAL RESEARCH COORDINATOR
Work Performed1.Clinical research operations. Screen, schedule, consent, andcollect adverse events (AE) information for participants in a varietyof studies. Maintain subjectlevel documentation,including documentation of consent in the electronic medical record.Prepare documents,equipment,or supplies forresearch visits. Conduct and document visits and protocol-specifictesting/interviews according tostudy protocol,operational plans of clinical departments, and Standard OperatingProcedures (SOPs) for all typesofstudiesindependently. Employ strategies to maintain recruitment and retentionrates, and to assistparticipants with individualneeds. Evaluate processes to identify issues related to recruitment andretention rates. Mayprovide training topersonnel.Collect, prepare, process, ship, and maintain inventory of researchspecimens and train others inthese tasks; improvesystems related to specimen handling.Prepare for study monitoring or study audit visits. Assist withaddressing and correcting findings.Develop or provide input for IRB documents. Maintain, or collaborate tomaintain, appropriatestudy-level documentation.Assist with management of Investigational Products (IP). Employ therequired system for handling,dispensing anddocumentation of IP for sponsored protocols. May be responsible fordetermining the bestmethods forhandling IP for Investigator-initiated protocols, or coordinating withinvestigational pharmacies asnecessary. Maintain appropriatedocumentation. Track IP compliance at the protocol-and subject level.Collect, prepare, or process adverse eventinformation per protocol, andprovide input for adverseevent reports. Maycomplete and submit AE Reports, according to institution andsponsor-specific reportingrequirements.Have familiarity with intellectual property rights, inventions patents,and technologies. Asappropriate, understandregulations related to investigational products with sponsors.Coordinate with Duke core services.Recognize the needfor agreements (e.g., Material Transfer Agreements, Investigational NewDrug Applications, etc.).2.Ethical and participant safety considerations. Maintainfamiliarity with the ethical conduct of research and safeguards neededwhen conducting research.Train junior staff in theethical conduct of research.May help in the design of studies so theyinclude specific safeguardsto ensure ethicalconduct and protect vulnerable populations.May develop, or assist with the development of, documents related tosafety and security.Communicate to research participants the difference between clinicalactivities and researchactivities, and the risks andbenefits of study participation.3.Data management and informatics. Use and train others inElectronic Data Capture (EDC) systems, technologies, and softwarenecessary for studyoperations.Score tests, enterdata, and complete Case Report Forms accurately and according toprotocol. Assist with thedevelopment of, or develop,data collection documents and instruments. Detect issues related todata capture, collection ormanagement; suggestsolutions.Investigate incomplete, inaccurate, or missing data/documents to ensureaccuracy andcompleteness ofdata; follow anddevelop, or assist with development of, SOPs for data qualityassurance. Adhere to processes andrunqueries,summaries, and reports to monitor the quality of data. May develop QAprocesses and oversee thecreation and use ofqueries, summaries, and reports for quality assurance purposes. May beresponsible forrecognizingtrends related todata quality and escalating as appropriate.Use required processes, policies, and systems to ensure data securityand data provenance.Recognizeand reportvulnerabilities related to security of physical and electronic data;suggest and implement solutionsto vulnerabilitiesrelated to security of data and dataprovenance.Map protocol data flow. Predict areas of vulnerability for a protocol'sdata flow plan. Determineareas where dataprovenance may be compromised and develop solutions.Recognize when data agreements or special regulatory requirements arenecessary; mayassemble thenecessaryparties to ensure that all agreements are in place.4.Scientific concepts and research design. Understand and train othersin the basic concepts ofstudy design.Independently conduct literature reviews. Assist with the developmentof, or develop, proposals orprotocols; identifyshortcomings of proposals andprotocols.Identify various stakeholders (statistical, operational, etc.) toensure adequate design,implementation, and testing ofstudy aims. May determine operational/statistical elements needed forconduct of clinical andtranslational studies.5.Leadership and professionalism. Assist research colleagues inidentifying efficiencies andimproving process.Successfully take part in or lead a committee or task force. Activelyseek out continuing educationopportunities for selfand study team members. Participate in or lead scientific presentationsand publications.Assign, review, and train others in various work responsibilities.Serve as a mentor to juniorstaff, including other CRCs.Employ escalation and performance plans as needed.Recognize and employ the professional guidelines and code of ethicsrelated to the conduct ofclinical research;summarize and clarify for study teams. May be responsible foridentifying potential problems andrisks to the participants,study, and institution.6.Study and site management. Participate in sponsor-requiredtraining. Obtain information for or coordinate operational plans formultiple research studies.Develop protocol-specificsystems and documents including process flows, training manuals, SOPs,and CRFs.Ensure participant care expenses have appropriate financial routing.Monitor financial studymilestones and reportappropriately. Coordinate with financialteams, PRMO, etc. Assist withstudy budgets.Prepare for, take part in, and potentially lead site initiation,monitoring, closeout visits, anddocument storage activities.Collect information to determine feasibility, recruitment and retentionstrategies. May makerecommendations toinvestigators and oversightorganization(s).Maintain compliance with institutional requirements and policies.Oversee maintenance ofDelegationof Authority Logsand training of KP on study specific duties.7.Communication and team science. Prepare for and lead teammeetings. Take an active role in including others in decision-making,and escalate issuesappropriately.Communicate with sponsors, subcontractors, or vendors. May beresponsible for taking actionwhencommunication hasstalled with sites, CROs, sponsors.Maintain Duke and project specific training requirements. Developsolutions to proactively ensurestudy team members'compliance withtraining requirements.Evaluate the need for cultural diversity and cultural competency in thedesign and conduct ofclinical research. Makerecommendations to investigative team.Knowledge, Skills and AbilitiesCan easily use computing software and web-based applications (e.g.,Microsoft Office productsandinternet browsers).
1201 CLINICAL RESEARCH COORDINATOR
Job Family Level
Full Time / Part Time
Regular / Temporary
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1.Completion of a Bachelor's degree2.Completion of an Associates degree plus a minimum of two yearsrelevant experience (e.g., research, clinical, interaction with studypopulation, program coordination)
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Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.
Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.