CLINICAL RESEARCH NURSE COORDINATOR at Duke University in Durham, North Carolina

Posted in Other 13 days ago.

Job Description:

School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

Work Preformed

Operations,Study and Site Management

- 40% Effo rt

Employ strategiesto maintain re cruitment and retention rates and assist participants withindividual nee ds. Collect information todetermine appropriate study feasibility, recr uitment, and retention strategies. Evaluate processes to identify issue s relatedto recruitment and retention rates; offer solutions.

Wo rk closely withthe Principal Investigator [PI] and study team to recruit , screen and enrollparticipants for studies. Conduct anddocument consen t for study participants. Schedule participants and conduct visits for s tudies; conduct and documentvisits.

Coordinate studyactivities w ith teammates and colleagues to successfully implement and conductthe st udy. Recognize and offer solutionsto study problems. Escalate issues ap propriately. Take part in site initiation and closeoutvisits. Assist i n the development of newstudies.

Maintain study'scompliance with i nstitutional requirements andpolicies. Maintain appropriate study-level documentation including regulatory binders, enrollment logs, and patient registration in the system of record. Record adverse events [AE] and re port promptly. Oversee maintenance of Delegation ofAuthority Logs andtr aining of key personnel on study specific duties.

Assist with thedevelopment of Conflict of Interest [COI], Data Safety MonitoringPla ns [DSMPs],and Research Data Security Plans [RDSPs]. Assist with thecoor dination of external monitoring boards.

Follow proceduresanddocum entation of study payment and participant care expenses in a timelyfashi on. Monitor financial studymilestones and report appropriately. Coordin ate with financial teams and participate in budget development. Assist with study budgets and closeouts.

- 5% Effort

Serve as primaryliaison w ith sponsors, study personnel and PI for assigned studies. Collaborate, and communicate with other studypersonnel as required. Communicateconc erns clearly in a professional manner. Respond timely to emails, phone calls and questions. Refer more complex questions and escalateissues to others as appropriate.


- 5% E ffort

Use Electronic DataCapture [EDC] systems and enter data accurately. Detect issues related to data capture,collection or management and suggest solutions.

Comply withrequiredproces ses, policies, and systems to ensure data security andprovenance. Recogn ize and reportvulnerabilitiesrelated to security of physical and electr onic data. Assist in investigating incomplete, inaccurateor missing dat a and documents to ensure accuracy and completeness of data.


- 5% Effort


Actively network. Provide leadership within theteam. Actively and proactively participate in teammeetings, committees,task forc es and ad hoc groups.

Encourage careerdevelopment by actively se eking out continuing education opportunities. Participate inscientific presentations andpublications.

Serve as an expertresource for co lleagues and teammates. Mentorstaff, including those in thesame job tit le. Support colleagues in their project work; encourage completion.


- 5% Effort

Communicate tostudy staff and research participants the difference bet ween clinical andresearch activities, and the risks and benefits of stud y participations. Recognize when staff and patients are havingdifficult y with the distinction and work hard to help them understandthedifferenc es.

Summarize andclarify for study teams, the professional guide lines and code of ethics relatedto the conduct of clinicalresearch.

Know and followpolicies, standard operating procedures[SOPs], regula tions and protocolrequirements that govern clinical research. Maintain D uke and project specific training and certification requirements.


-40% Effort em>

·AmbulatoryMedication Administ ration

·Medicationmanagement to in clude patient education on specific study medications and sideeffects

·AdultChemotherapy Administration

·BasicDysrhythmia Review

·Reviewclinical laboratory results

·Assesspatient to recognizeadverse events, check patient compliance, provideeducation and appropriate interventions as guided by Principal Investigator [PI].

· span>Interacteffectively with medical team.

Othe r work as assigned.

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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