CLINICAL RESEARCH NURSE COORDINATOR
CLINICAL RESEARCH NURSE COORDINATOR
Ctr Applied Genomics and Precision Med
Registered Nurse Coordinator expected to administer medication, physical medication, take doctor's order, manage own workload, take orders, conduct unscripted interviews, evaluate clinical data, complete physical assessment, make judgments based on assessment of patients, consent patients through informed consent; collect, interpret, and document data.
Capable of independently running more than one trial and managing more than one protocol; will serve as work/cluster lead of a division within a CRU or a function within the CRU; may serve as a supervisor of Level 1 and II CRC-RNs.
Coordinate and participate in clinical research studies conducted by a supervising physician to ensure that patient treatment provided by primary care personnel and data collected adhere to study protocol; screen patients for inclusion in study based on pre-determined criteria; maintain inventory of unique drugs and supplies needed for study; provide basic patient care and treatment as requested by physician.
Obtain patient blood samples, cultures, tissues and other specimens for laboratory analysis; initiate drug orders and laboratory studies for patients based on standing protocol orders.
Provide direction and training to nursing staff on techniques for mixing and administering new drugs and other forms of patient care and treatment unique to the study being conducted; maintain interface with nursing and other professional personnel to interpret protocol application for a given patient and to answer questions about the study in progress.
Confer with patient and attending physician to explain purpose of study and obtain written consent for patient to participate; explain diagnostic procedures and method of treatment to alleviate patient and family concern.
Collect information and data from patient charts and records, patient interviews and other sources; evaluate and interpret collected data and prepare protocol summary forms, statistical reports and analyses setting forth progress, adverse trends and appropriate recommendations or conclusions.
Confer with physician in developing plans and protocols for clinical research studies and to discuss the interpretation of results and the preparation of manuscripts for publication.
Prepare and process all regulatory documentation through the Institutional Review Board (IRB) and other entities as required, including amendments, continuing reviews, and adverse event reporting.
Prepare and process all regulatory documentation with pharmaceutical companies and clinical research organizations (CROs).
Resolve regulatory related queries with IRB, study sponsors, and CRO. Accountable to ARPM or RPM for regulatory coordination.
Conduct initiation, monitoring and closeout visits with sponsors and/or CROs.
Participate in the conduct of audits by study sponsors, CROs, the FDA, and other groups.
Perform other related duties incidental to the work described herein. The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
1203 CLINICAL RESEARCH NURSE COORDINATOR
Job Family Level
Full Time / Part Time
Regular / Temporary
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion,sexual orientation, or veteran status.Essential Physical Job Functions:Certain jobs at Duke University and Duke University Health System may include essential job 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.
Work requires graduation from an accredited BSN or Associate's Degree in Nursing or Nursing Diploma program.All registered nurses without a Bachelor's 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.
Twelve months of appropriate clinical experience is required.
Auto req ID
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.
Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job 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.