CLINICAL RESEARCH COORDINATOR
CLINICAL RESEARCH COORDINATOR
Operations:Screen participants for all studies independently. Maintain subjectlevel documentation for allstudies independentlySchedule participants and conduct visits forminimal risk studiesindependently. Collect, prepare, process, ship, and maintain inventoryof research specimens.Describe the various steps involved in handling IP. Assist withmanagement of InvestigationalProducts (IP) including arrival, storage, handling including requestingrequisitions, inventory, andreordering Independently maintain appropriate study-level documentationincluding regulatorybinders, enrollment logs, patient registration in the system of record,etc. Employ strategies tomaintain recruitment and retention rates, and to assist participantswith individual needs. Evaluateprocesses to identify issues related to recruitment and retentionrates. Conduct and documentconsent for participants in a variety of studies independently Assistwith addressing and correctingfindings from study monitoring and study audit visits. Collect, prepareor process adverse eventinformation independently Complete and submit AE Reports, according toinstitution and sponsor-specific prompt reporting requirements (timelines and forms)independently. Develop DUHS IRBdocuments such as consent forms, protocols, and continuing reviewsindependently.Ethics:Communicate to research participants, both orally and written, thedifference between clinicalactivities and research activities in all study documents and researchparticipant communications.Be familiar with the ethical conduct of research, and safeguards neededwhen conducting researchwith vulnerable populations. Understand that the safety of researchparticipants is a priority. Assistwith the development of Conflict of Interest (COI)/Data SafetyMonitoring Plans(DSMPs)/Research Data Security Plans (RDSPs). Assist with thecoordination of efforts ofexternal monitoring boards. Identify and the explain the risk andbenefits to a subject as thesepertain to your clinical trialData:Use Electronic Data Capture (EDC) systems, technologies, and softwarenecessary for studyoperations with little assistance. Enter data accurately. Score testsand measures according toprotocol, and appropriate to role. Complete paper and electronic CaseReport Forms (CRFs andeCRFs) accurately and according to protocol. Use required processes,policies, and systems toensure data security and provenance. Recognize and reportvulnerabilities related to security ofphysical and electronic data. Independently investigate incomplete,inaccurate or missingdata/documents to ensure accuracy and completeness of data. Runsummaries and reports onexisting data Follow SOPs for data QA.Science:Leadership:Recognize and employ the professional guidelines and code of ethicsrelated to the conduct ofclinical research. Maintain Duke and project specific trainingrequirements. Evaluate the need forcultural diversity and cultural competency in the design and conduct ofclinical research. Makerecommendations to investigative team.Study and Site Management:Maintain study's compliance with institutional requirements and otherpolicies (e.g., NIH PublicAccess policy, ct.gov, Research Data Security Plans, Social Mediapolicy, etc.). Overseemaintenance of Delegation of Authority Logs and training of keypersonnel on study specific duties.Take part in site initiation/closeout visits as directed. Take part inor lead closeout and documentstorage activitiesCommunication:Write and speak clearly in a variety of settings and styles to conveymessages and ideaseffectively. Participate in study team meetings. Respond to routinequestions related to studyprotocol and refer more complex questions to others as appropriate.Communicate andcoordinate with other study personnel as required for studyimplementation and routine problemresolution.Description of Portfolio and Clinical Responsibilities:Portfolio Management (Effort %):Clinical responsibilities:• Other:Type of ResearchThis positionwill be working within the infectious disease clinicmainly with HIV infected subjects.They will be enrolling and conducting study visits for multi yearstudies highly funded by grants.Special SkillsWe would like to find someone that has experience with consenting andscreening for researchparticipants.
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.