Job description

diversity employer

Reproductive Endocrinology & Fertility

OBGYN-Division of Reproductive Endocrine and Fertility Clinical Research Coordinator

Occupational Summary

This position will coordinate and manage clinical research studies investigating problems in female and male infertility, gynecologic and male reproductive system diseases and disorders that impact fertility, problems in andrology and endocrinology affecting reproduction.

Work Performed

Operations:Screen participants for all studies independently.

Maintain subject level documentation for all studies independently Schedule participants and conduct visits for minimal risk studies independently. Create, optimize, and oversee systems to collect,prepare, process, ship, and maintain inventory of research specimens and train others in these tasks. Assist with management of IP. Employ the required system for handling, dispensing and documentation of IP for sponsored protocols. May be responsible for determining the best methods for handling IP for Investigator-initiated protocols, or coordinating with investigationalffpharmacies as necessary.Maintain appropriate documentation. Track IP compliance at theprotocol-and subject level. Trainfstaff to maintain exemplary documentation including regulatory binders,enrollment logs, patientregistration in the system of record, subject level documentation, etc.Oversee maintenance ofsubject level documentation. Employ strategies to maintain recruitmentand retention rates, and toassist participants with individual needs. Conduct and document consentfor participants in avariety of studies independently and provide training to others inthese tasks. Provide direction tostudy teams with preparation for study monitoring or study auditvisits. Address and correctaudit/monitor findings. Oversee the collection of adverse eventinformation Complete and submitAEReports, according to institution and sponsor-specific prompt reportingrequirements (timelines andforms) independently. Develop DUHS IRB documents such as consentforms, protocols, andcontinuingreviews independently.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.Develop documents related to safety and security (e.g., RDSPs, COIs,DSMPs). Coordinateefforts ofexternal monitoring boards. Articulate, to study staff and researchparticipants, thepathophysiology or reasoning for an individual protocol's inclusion andexclusion criteria.Data: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 to ensure datasecurity and provenance. Recognize and report vulnerabilities relatedto security of physical andelectronic data. Independently investigate incomplete, inaccurate ormissing data/documents toensure accuracy and completeness of data. Run summaries and reports onexisting data FollowSOPs fordata QA. Recognize when data agreements are necessaryScience:Conduct literature reviews under the direction of the CRC, CRNC, or PILeadership:Encourage and support colleagues in completing project work. Assistresearch colleagues inidentifying efficiencies and improving process. May serve as mentor toother staff. Recognize andemploy the professional guidelines and code of ethics related to theconduct of clinical research.Maintain training requirements and develop solutions to proactivelyensure study team members'compliance with training requirements.Study and Site Management:Collect information to determine appropriatefeasibility, recruitmentand retention strategies.Ensure participant care expenseshave appropriate financial routing in atimely manner. Monitorfinancial study milestones and report appropriately. Coordinate withfinancial teams, PRMO, etc.and participate in budget development as appropriate. Assist withstudy budgets. Use systemreports to ensure unit, division, or department compliance withinstitutional requirement/policies;assist team members with understanding these requirements and policies.Oversee study teams'maintenance of Delegation of Authority Logs and training of keypersonnel on study specific duties.Take part in site initiation and closeout meetings independently Assistwith the development ofprotocol-specific systems and documents including process flows,training manuals, standardoperatingprocedures, and case report forms. Prepare for closeout anddocument storageCommunication:Serve as primary liaison with single sponsor, subcontractor, orvendors. Communicate concernsclearly and in a professional manner. Participate in study teammeetings. Respond to routinequestions related to study protocol and refer more complex questions toothers as appropriate.Communicate and coordinate with other study personnel as required forstudy implementation androutine problem resolution.Required Qualifications at this LevelEducation/Training: 1.Completion of a Bachelor's degree 2.Completion ofan Associatesdegree plus aminimum of two years relevant experience (e.g., research, clinical,interaction with studypopulation, program coordination) ________________________________________Skills: Can easily use computing software and web-based applications(e.g., Microsoft Officeproducts and internet browsers).

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: 10/12/2018
Application Due: 11/3/2018
Work Type: