CLINICAL RESEARCH SPECIALIST, SR

    Duke University
    Durham, NC 27701
    Full-time, Part-time
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    Job Description

    School of Medicine:

    Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.

    Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

    Occ Summary Work PerformedKnowledge,Skills and Abi litiesPerform other related duties incidental to the work described here in.assigned to this classification.classified.the general nature and lev elof work being performed by individualsThe above statements describeint ended to be an exhaustive list of all responsibilities and dutiesrequire dof personnel soclinical research data.populations.study implementationa ndCommunicate and coordinate with other study personnel as required forP erform a variety of research, data, and clerical duties of a routineques tions related to study protocol and refer more complex questions toother s as appropriate.Respond to routineand technical nature to supportthe co nduct of clinical researchunderthe supervision of a ClinicalResearch Coo rdinator or similar CRU/Oversight Organization designee.Participate inda y-to-dayoperations related to the collection,compilation, and documenta tion of1.Clinical research operations. Screen, schedule, conduct visits, andThis is not consent participants in minimal risk studies, includingd ocumentationof consent in theelectronic medical record; may conduct thes e activities for studieswith greater than minimal riskunder supervision. Prepare documents, equipment, or supplies forresearch visits. Conductan ddocument visits and protocol-specific testing/interviews according tost udy protocol, operationalplans of clinical departments, and StandardOper ating Procedures(SOPs). Employ strategies tomaintain recruitment andrete ntion rates, and to assist participantswith individual needs. Collect,pr epare, process, ship, and maintain inventory of research specimensand tr ain others in thesetasks. Collect, prepare or process adverse event inf ormation undersupervision. Provide input foradverse events reports.Assis t with maintenance of studyleveldocumentation. Prepare for studymonitori ng or study audit visits.Provide inputfor DUHS Institutional Review Boar d documents such asconsent forms, protocols,and continuing reviews.Assis t with management of Investigational Products including arrival,storage, handling includingrequesting requisitions, inventory, andreordering2.Et hical and participant safety considerations. Maintain familiaritywith th e ethical conduct ofresearch and safeguards needed when conducting resea rch with vulnerableUnderstand that the safety of research participants i s a priority.3.Data management andinformatics. Use and train others in E lectronic Data Capture (EDC)systems, technologies, andsoftware necessary for study operations. Enter data accurately. Scoretests and measures aa ccordingaccording to protocol and appropriate to role. Complete paper an delectronicCaseReport Forms (CRFs and eCRFs) accurately and according t oprotocol.Assist with thedevelopment of data collection documentsto stan dardize process Map aprotocol's data flow plan;including data capture, s torage, management, quality, and preparationfor analysis. Independentlyi nvestigate incomplete, inaccurate, or missing data/documents toensureacc uracy andcompleteness of data; follow and assist with development of SOP s fordata quality assurance. Runsummaries and reports on existing data. Use required processes,policies, and systems to ensurerelatedto securit y ofdata security and data provenance.Recognize and report vulnerabilit iesphysical and electronic data.4.Scientific concepts and research desig n. May conduct literaturereviews under the direction ofthe CRC, CRC-RN, or PI. Identify various stakeholders (statistical,operational, etc.) to ensureadequate design, implementation, andtesting of study aims.5.Lead ership and professionalism.Encourage and support colleagues tocomplete p roject work.process. Recognize andAssist research colleaguesin identifyi ng efficiencies and improvingemploy the professional guidelines and code of ethics related to theconduct of clinical research.Maintain Duke and project specific training requirements. May serve asmentor to other staf f.6.Study and site management. Participate in sponsor-required training. Maintain inventory andquality of study supplies and equipment. Prepare i tems for siteinitiationvisits, and take part invisits as requested/direc ted. Asist with the development ofprotocol-specific systemsanddocuments including process flows, training manuals,standard operatingprocedures, and casereport forms.7.Communication and team science. Participate in s tudy team meetings.routine problem resolution. Write and speak clearlyi n avariety ofsettings and styles to conveymessages and ideas effectivel y.Can easily use computing software and web-based applications (e.g.,Mic rosoft Office productsandinternet browsers).

    Minimum Qualifications

    Education

    Work requires an Associate's degree.

    Experience

    One year of relevant experience. A Bachelor's degree may substitute for required experience.

    Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, 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 robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

    Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob 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.

    Nearest Major Market: Durham
    Nearest Secondary Market: Raleigh

    Posting ID: 593559511Posted: 2020-12-17