Duke University

Durham, North Carolina

This job has expired.

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

Participate in or lead day to day operations of clinical research studies conducted by principal investigator(s) at Duke Medicine; perform a variety of duties involved in the collection, compi lation, documentation, and analysis of clinical research data. May overs ee the work of junior staff and train or mentor others in clinical resea rch tasks. Provide and document professional nursing care forresearch p articipants.

Work Performed

Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessaryand alerts appropriate parties. Knowledgeable in regulatory and institutionalpolicies and processes; appliesappropria tely in study documentation, protocol submissions, and SOPs. May trainot hers in these policies and processes. Is responsible for all aspects ofm anaging and documenting Investigational Product (IP); including arrival, storage, tracking, and provision to research participants. Serves as the primary liaison with sponsors, IDS, and other parties as necessary. Foll owsprotocol schema for randomization and blinding/unblinding. May train others.Prepares for and provides support for study monitoring and audit visits, includingsupportfor the reviewer. Addresses and corrects findin gs. May train others.Maintains participant level documentation for all s tudies, including those thatare complex in nature (e.g., procedural and interventional studies) and/orrequire access to the Duke EHR. May train or oversee others. Employs strategiesto maintain retention rates. Evalua tes processes to identify problems withretention. May train or oversee o thers. Employs and may develop strategies tomaintain recruitment rates a nd evaluate processes to identify problems.Escalates issues. May train o r oversee others. Screens participants for complexstudies (e.g., procedu ral and interventional studies). May train or overseeothers. Develops or helps develop SOPs. May train or oversee others. Collects,prepares, pro cesses, ships, and maintains the inventory of research specimens,primari ly those requiring complex procedures. May train or oversee others.Maint ains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies). May tra in oroversee others. Conducts and plans for complex study visits. May tr ain staff.Leads meetings that are multidisciplinary, including those wit h complexobjectives.

Identifies all AEs, and determines whether or not they are reportable. Collaborates with th e PI to determine AEattributes, including relatedness to study. May trai n or oversee others.Conducts and documents consent for participants for all types of studies,including those that are complex in nature and/or r equire any orders in MaestroCare. May train or oversee others. Develops consent plans and documents forparticipants in a variety of studies. May train or oversee others. Develops andsubmits documentation and informat ion forIRB review. Communicates with the IRBstaff and reviewers and han dles issues appropriately. May train or overseeothers. Prepares and subm its documents needed for regulatory and safetyreporting to sponsors and other agencies. May train or oversee others.

Enters and collects data. Develops dataentry or collection SOPs or to ols. May provide oversight or training to studyteam members collecting o r entering data. Independently corrects and documentsincomplete, inaccur ate or missing data for non-complex studies. Follows SOPsfor quality ass urance. Runs summaries and reports on existing data. Followsrequired pro cesses, policies, and systems to ensure data security andprovenance. In addition, recognizes andreports security ofphysical and electronic dat a vulnerabilities. Maps aprotocol's data flow plan including data captur e, storage, transfer,management, quality, and preparation for analysis ( may include data from EDCs,EHR, mobile apps, etc.). May train or oversee others.Independently uses andimplements technology to enhance producti vity or process. May train or overseeothers.

May assist with simple literature searches under supervision from P I or CRC.Provides some contribution to scientific publications or presen tations (no authorship).

Study and Site Management:
Prepares for, coordinates, and actively participates in site visits.Co mmunicates effectively with sponsors and/or CROs. Uses clinical research management system and its reports to manage research participants' activ ities,calendars, tracking/marking financial milestones, and all aspects of studyvisits. Uses required EMR functionalities to manage participants and studyvisits. May train others. Uses clinicalresearch management sy stem and its reports to manage all protocol activities,including minimum footprint, SIP counsel, and all aspects of maintainingcurrent protocol information. May train others. Collects appropriateinformation to determ ine whether the study team's participation in a specifictrial is feasibl e. May make recommendations. For studies with complex suppliesor equipme nt, ensures that there are ample supplies and that equipment is ingood w orking order. May forecast staffing needs. Maytrain or oversee others.E nsures that studies are conducted in compliance with institutionalrequir ements and other policies. Follows, and may develop or implement,protoco l-specific systems and documents including process flows. May train orov ersee others. Prepares studies for closeout and document storage. May tr ainor oversee others.

Works with the manager to understand areas of opportunity and develop atraining plan. T akes training courses and applies the knowledge and skills. Mayalso trai n others in the skills learned. Keeps current with research updates byat tending key external offerings (i.e. Research Wednesday, RPN, events out sideof Duke, etc.) and applies the learned material to the job. May diss eminateinformation to others. Serves on committees and workgroups intern al to Duke orexternally in therapeutic area of research. Demonstrates in terpersonal skillsto get work done efficiently. Recognizes and escalates organizational issuesthat could be optimized to improve research proces s. Demonstrates resilienceand is adaptive to change. Uses advanced subje ct matter expertise in thetherapeutic area or clinical research to solve problems. Communicateseffectively with others, regardless of reporting relationship, to accomplishshared work objectives.

Minimum Qualifications


Work requires graduation from an accredited BSN or Associates Degree in Nursing or Nursing Diploma program. All registered nurses without a Bachelors degree in Nursing (or higher) will be required to enroll in an appropriate BSN program within two years of their start date and to complete the program within five years of their start date. Must have current or compact RN licensure in the state of North Carolina. BLS required. Maintain compliance with required hospital and unit specific training competencies as well as an active RN status with the North Carolina Board of Nursing (NCBON).


Twelve months of appropriate clinical nursing experience is required.

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.

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