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.
Participate in or lead day to day operations of c linical researchstudies conducted by principal investigator(s) at Duke H ealth; perform avariety of duties involved in the collection, compilatio n,documentation, and analysis of clinical research data. May oversee the work of junior staff and train or mentor others in clinical researchtask s.
Research Operations.Knowledgeable i n regulatory and institutional policies and processes;applies appropriat ely in study documentation, protocol submissions, andstandard operating procedures (SOPs).Screen participants for complex studies (e.g., procedu ral andinterventional studies).Develops or helps develop SOPs.Employs an d may develop strategies to maintain recruitment and retentionrates and evaluate processes to identify problems.Escalates issues.Conducts and pl ans for visits for complex studies (e.g., procedural andinterventional s tudies).Maintains participant level and study level documentation for al lstudies, including those that are complex in nature and/or requireacces s to the Duke electronic health record (EHR).Prepares for and provides s upport for study monitoring and audit visits,including support for the r eviewer.Addresses and corrects findings.Is responsible for all aspects o f managing and documentingInvestigational Product (IP); including arriva l, storage, tracking, andprovision to research participants.Serves as th e primary liaison with sponsors, Investigational DrugService (IDS), and other parties as necessary.Follows protocol schema for randomization and blinding/unbinding.Collects, prepares, processes, ships, and maintains the inventory ofresearch specimens, primarily those requiring complex pr ocedures.May maintain study level documentation for international studie s anddevelop resources and tools for management of international studies ,and/or coordinate with other entities or offices.May prepare Federal Dr ug Administration (FDA) regulatory submissions incollaboration with Office of Regulatory Affairs and Quality (ORAQ),including development, submi ssion, and maintenance of relevantdocumentation.Addresses FDA review and /or potential hold issues in collaboration withthe Principal Investigato r (PI).Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) arenecessary and alerts appropriate parties.Leads meetings that are mul tidisciplinary, including those with complexobjectives.Safety and Ethics .Conducts and documents consent for participants for all types ofstudies, including those that are complex in nature and/or require anyorders in Maestro Care.Develops consentplans and documents for participants in a variety ofstudies.Develops and submits documentation and information fo r InstitutionalReview Board (IRB) review.Communicates with the IRB staff and reviewers and handle issuesappropriately. Identifies all adverse ev ents (AEs), and determineswhether or not they are reportable.Collaborate s with the PI to determine AE attributes, includingrelatedness to study. Prepares and submits documents needed for regulatory and safetyreporting to sponsors and other agencies.Responsible for adherence to clinical re search policies to ensureethical conduct and protect vulnerable populati ons.Communicate to research participants the difference between clinical activities and research activities, and the risks and benefits of studyp articipation.Data.Enters and collects data, and develops data entry or c ollection SOPs ortools.May provide oversight or training tostudy team m embers collecting orentering data.Ensures accuracy and completeness of d ata for all studies.Recognizes data quality trends and escalates as appr opriate.May develop tools for, and train others in, data quality assuran ceprocedures.Recognizes and reports security of physical and electronic datavulnerabilities.May develop or review research data security plans ( RDSPs) for multiplestudy protocols.Maps a protocols data flow plan inclu ding data capture, storage,transfer, management, quality, and preparatio n for analysis (may includedata from EDCs, EHR, mobile apps, etc.).Indep endently uses and implements technology to enhance productivity orproces s.Scientific Concepts.Assists with or contributes to the development of funding proposals.Using scientific proposals from the PI, develops resea rch protocols.Demonstrates a basic understanding of the elements of rese archstudydesigns.Independently conducts literature searches and reviews . Contributes tothe development of scientific publications or presentati ons and servesas an author on poster presentations or publications.Site and Study Management.Collects appropriate information to determine wheth er the study teamsparticipation in a specific trial is feasible.May make feasibility recommendations.Ensures that studies are conducted in compl iance with institutionalrequirements and other policies. Follows, and ma y develop or implement,protocol specific systems and documents including process flows.Prepares for, coordinates, and actively participates in s ite visits.Communicates effectively with sponsors and/or contract resear chorganizations (CROs).For studies with complex supplies or equipment, e nsures that there areample supplies and that equipment is in good workin g order.May forecast staffing needs.Uses systems and system reports to m anage research participantsactivities and charge routing.Prepares studie s for closeout and document storage.Leadership and professionalism.May t rain or oversee others in the above tasks. Proactively seeksopportunitie s to add relevant skills and certifications to ownportfolio.Keeps curren t with research updates by attending key external offerings(i.e. Researc h Wednesday, RPN, events outside of Duke, etc.) and appliesthe learned m aterial to the job.May disseminate information to others.Uses advanced s ubject matter expertise in the therapeutic area orclinical research to s olve problems.Navigates processes and people involved in Duke clinical r esearch,demonstrates the organizational awareness, and has the interpers onalskills necessary to get work done efficiently.May serve on committee s and workgroups internal to Duke or externally intherapeutic area of re search.Demonstrates resilience and is adaptive to change.Communicates ef fectively with others, regardless of reportingrelationship, to accomplis h shared work objectives.
Knowledge, Skills and Abilities
Can easily use computing software and web based applications (e.g. ,Microsoft Office products and internet browsers).
Completion of an Associate's degree
Work requires a minimum of two years of relevant research experience. A Bachelor's degree may substitute for 2 years required experience.
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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.