Job description

diversity employer

Heart Center SBR

Operations:Screen participants for all studies independently. Maintain subjectlevel documentation for allstudiesindependently Schedule participants and conduct visits for minimal riskstudies independently.Collect,prepare, process, ship, and maintain inventory of research specimens.Assist with management ofIP.Employ the required system for handling, dispensing and documentationof IP for sponsoredprotocols.May be responsible for determining the best methods for handling IP forInvestigator-initiatedprotocols, or coordinating with investigational pharmacies asnecessary. Maintain appropriatedocumentation. Track IP compliance at the protocol-and subjectlevel.Independently maintainappropriate study-level documentation including regulatory binders,enrollment logs, patientregistration in the system of record, etc. Employ strategies tomaintain recruitment and retentionrates,and to assist participants with individual needs. Conduct and documentconsent for participants in avariety of studies independently Assist with addressing and correctingfindings from studymonitoringand study audit visits. Collect, prepare or process adverse eventinformation under supervision.Complete and submit Adverse Events Reports, according to institutionand sponsor-specific promptreporting requirements (timelines and forms) under supervision. DevelopDUHS IRB documentssuchas consent forms, protocols, and continuing reviews independently.Ethics:Communicate to research participants, both orally andwritten, thedifference between clinicalactivitiesand research activities in all study documents and research participantcommunications. Be familiarwith the ethical conduct of research, and safeguards needed whenconducting research withvulnerable populations. Understand that the safety of researchparticipants is a priority. Assist withthedevelopment of Conflict of Interest (COI)/Data Safety Monitoring Plans(DSMPs)/Research DataSecurity Plans (RDSPs). Assist with the coordination of efforts ofexternal monitoringLeadership:Encourage and support colleagues in completing project work. Assistresearch colleagues inidentifying efficiencies and improving process. Recognize and employthe professional guidelinesandcode of ethics related to the conduct of clinical research. MaintainDuke and project specifictrainingrequirements. Evaluate the need for cultural diversity and culturalcompetency in the design andconduct of clinical research. Make recommendations to investigativeteam.Study and Site Management:Collect information to determine appropriate feasibility, recruitmentand retention strategies.Maintainstudy's compliance with institutional requirements and other policies(e.g., NIH Public Accesspolicy,, Research Data Security Plans, Social Media policy, etc.).Oversee maintenance ofDelegationof Authority Logs and training of key personnel on study specificduties. Take part in siteinitiation/closeout visits as directed. Assist with the development ofprotocol-specific systems anddocuments including process flows, training manuals, standard operatingprocedures, and casereportforms. Take part in or lead closeout and document storage activitiesCommunication:Serve as primary liaison with single sponsor, subcontractor, orvendors. Communicate concernsclearly and in a professional manner. Participate in study teammeetings. Respond to routinequestionsrelated to study protocol and refer more complex questions to others asappropriate.Communicateand coordinate with other study personnel as required for studyimplementation and routineproblemresolution.

Requisition Number


Duke Entity

Job Code

Job Family Level


Full Time / Part Time

Regular / Temporary


Minimum Qualifications
Duke University is an Affirmative Action/Equal Opportunity Employercommitted to providing employment opportunity without regard to anindividual's age, color, disability, gender, gender expression, genderidentity, genetic information, national origin, race, religion, sex,sexual orientation, or veteran status.
Duke aspires to create a community built on collaboration, innovation,creativity, and belonging. Our collective success depends on the robustexchange of ideas—an exchange that is best when the rich diversity ofour perspectives, backgrounds, and experiences flourishes. To achievethis exchange, it is essential that all members of the community feelsecure and welcome, that the contributions of all individuals arerespected, and that all voices are heard. All members of our communityhave a responsibility to uphold these values.
Essential Physical Job Functions:Certain jobs at Duke University and Duke University Health System mayinclude essential job functions that require specific physical and/ormental abilities. Additional information and provision for requests forreasonable accommodation will be provided by each hiring department.


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)

Auto req ID


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.





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Job No:
Posted: 5/9/2018
Application Due: 6/9/2018
Work Type: