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CLINICAL RESEARCH NURSE COORDINATOR, DCRI - DEPRU

Employer
Duke University
Location
DUKE EARLY PHASE RESEARCH UNIT

Job Details

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.

Position Summary

Coordinates and participates in clinical research studies conducted in the Duke Early Phase Research Unit (DEPRU). DEPRU is a phase 1 research unit that sees both adult and pediatric participants from a variety of therapeutic areas. The nurse in this position will work very closely with the clinical nursing team and will report to the nurse manager of the unit. They will function in the RN role, as well as the CRC role, but will have clinical responsibilities including, but not limited to, placing IVs, performing ECGs, collecting various samples, administering medications and processing samples. This position would be ideal for an experienced RN who is interested in growing in the research arena. BLS is required. ACLS must be completed within the first six months of employment and PALS within the first year.

Work Performed.

Reviews protocols provided by investigators and sponsors; creates materials to be used for source documents; oversees the organization of relevant study materials in subject’s folders/binders; provides input into the IRB submission process.
Performs screening activities for trial coordination by identifying appropriate candidates according to specific inclusion/exclusion criteria; presents study information to volunteers; collaborates with recruiting staff to provide informed consent sessions and obtains informed consent, adhering to NIH, FDA and ICH guidelines throughout this process.
Participates in screening procedures required by protocols. Follows established GCP guidelines in the performance of study procedures and in the collection and documentation of clinical data; trains new employees in the understanding and application of these guidelines; coordinates the completion of case report forms accurately and within timeline specified by the sponsor and unit management; coordinates response to data queries and initiates corrective action if needed.
Participates in quality assurance and quality control activities to ensure appropriate and effective conduct of each phase of the clinical trials and for the safety of study subjects.
Prepares and organizes materials and supporting documents to be presented in audits; participates in audits of clinical trials initiated by study sponsors and/or regulatory agencies. Provides input into select aspects of study budgets; assures the availability of supplies and equipment; initiates requests for clinical and other purchases as Coordinates and implements procedures necessary to achieve an accurate system for drug accountability; orients and trains staff on these procedures.
Ensures that drug accountability procedures comply with regulatory guidelines and that personnel are knowledgeable in these Ensures compliance with protocol guidelines and ongoing requirements of agencies; identifies problems and/or inconsistencies and takes corrective action, reporting to management as appropriate; participates in interactions with management to address research process/procedure improvements as appropriate. Prepares materials for various reports required by investigators, sponsors, and the IRB. Provides input into the development of standard operating procedures (SOPs); participates in periodic review of SOPs providing updates and revisions s as Maintains ongoing communication with faculty, study coordinators, investigators, and sponsors to ensure for the safe and timely progression of clinical trials and adherence to protocol requirements.
Demonstrates knowledge and application of all privacy and safety job responsibilities, human subjects, staff, and the general operation standards as they relate to of the unit.
Assures that the documentation, reporting and follow-up of all adverse events is carried out per GCP and IRB guidelines.

Minimum Qualifications Education

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 completethe 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 statuswith the North Carolina Board of Nursing (NCBON).

Experience

Twelve months of appropriate clinical nursing experience is required, preferably in a research setting and/or critical care area of practice.

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.

Organization

Read our Diversity Profile History

Duke University was created in 1924 by James Buchanan Duke as a memorial to his father, Washington Duke. The Dukes, a Durham family that built a worldwide financial empire in the manufacture of tobacco products and developed electricity production in the Carolinas, long had been interested in Trinity College. Trinity traced its roots to 1838 in nearby Randolph County when local Methodist and Quaker communities opened Union Institute. The school, then named Trinity College, moved to Durham in 1892, where Benjamin Newton Duke served as a primary benefactor and link with the Duke family until his death in 1929. In December 1924, the provisions of indenture by Benjamin’s brother, James B. Duke, created the family philanthropic foundation, The Duke Endowment, which provided for the expansion of Trinity College into Duke University.Duke Campus

As a result of the Duke gift, Trinity underwent both physical and academic expansion. The original Durham campus became known as East Campus when it was rebuilt in stately Georgian architecture. West Campus, Gothic in style and dominated by the soaring 210-foot tower of Duke Chapel, opened in 1930. East Campus served as home of the Woman's College of Duke University until 1972, when the men's and women's undergraduate colleges merged. Both men and women undergraduates now enroll in either the Trinity College of Arts & Sciences or the Pratt School of Engineering. In 1995, East Campus became the home for all first-year students.

Duke maintains a historic affiliation with the United Methodist Church.

Home of the Blue Devils, Duke University has about 13,000 undergraduate and graduate students and a world-class faculty helping to expand the frontiers of knowledge. The university has a strong commitment to applying knowledge in service to society, both near its North Carolina campus and around the world.

Mission Statement

Duke Science"James B. Duke's founding Indenture of Duke University directed the members of the University to 'provide real leadership in the educational world' by choosing individuals of 'outstanding character, ability, and vision' to serve as its officers, trustees and faculty; by carefully selecting students of 'character, determination and application;' and by pursuing those areas of teaching and scholarship that would 'most help to develop our resources, increase our wisdom, and promote human happiness.'

“To these ends, the mission of Duke University is to provide a superior liberal education to undergraduate students, attending not only to their intellectual growth but also to their development as adults committed to high ethical standards and full participation as leaders in their communities; to prepare future members of the learned professions for lives of skilled and ethical service by providing excellent graduate and professional education; to advance the frontiers of knowledge and contribute boldly to the international community of scholarship; to promote an intellectual environment built on a commitment to free and open inquiry; to help those who suffer, cure disease, and promote health, through sophisticated medical research and thoughtful patient care; to provide wide ranging educational opportunities, on and beyond our campuses, for traditional students, active professionals and life-long learners using the power of information technologies; and to promote a deep appreciation for the range of human difference and potential, a sense of the obligations and rewards of citizenship, and a commitment to learning, freedom and truth.Duke Meeting

 “By pursuing these objectives with vision and integrity, Duke University seeks to engage the mind, elevate the spirit, and stimulate the best effort of all who are associated with the University; to contribute in diverse ways to the local community, the state, the nation and the world; and to attain and maintain a place of real leadership in all that we do.”

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