CLINICAL RESEARCH NURSE COORDINATOR, DEPRU
- Location: Durham, NC
- Posted: Jan 17, 2020
School of Medicine:
Established in 1930, Duke University School of Medicine is the youngest of the nations 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.
Coordinates and participates in clinical research studies conducted in Duke Early Phase Clinical Research Unit (DEPRU). Coordinates and participates in a variety of duties involved in the collection, compilation, documentation and analysis of clinical research data. Coordinates nursing efforts with investigators and their staff, laboratory, nutrition, and recruiting personnel in planning, implementing and evaluating care to clinical research subjects.
Reviews protocols provided by investigators and sponsors; creates materials to be used for source documents; oversees the organization of relevant study materials in subjects 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.
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).
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 ideasan 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.