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CLINICAL RESEARCH NURSE COORDINATOR

Job description


diversity employer



CLINICAL RESEARCH NURSE COORDINATOR
DUKE EARLY PHASE RESEARCH UNIT

Occupational Summary Work Performed Perform other related duties incidental to the work described herein. The above statements describe the general nature and level of work Experience appropriate. appropriate. being performed by responsibilities and duties required of personnel so classified. Education/Training guidelines. individuals assigned to this classification. This is not intended to be regulatory Coordinates and participates in clinical research studies conducted in the DCRU. Coordinates and participates ina 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 subject#s folders/binders; provides input into the IRB submission process. Performs screening activities for trial coordinationby 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 eachphase of the clinical trialsand for the safety of study subjects. Prepares and organizes materials and supportingdocuments 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 protocolguidelines and ongoingrequirements 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 andapplication of all privacy and safety job responsibilities, humansubjects, 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. an exhaustive list of Work requires current unrestricted licensure by the state of North Carolina as a Registered Nurse Two years of previous clinical or health-related experience, preferably in a research setting and/or critical carearea of practice. Previous management experience preferred. Excellent organization, presentation, and communication skills required. Computer skills including word processing are required. Reporting Relationship Direct line reporting relationship to the Clinical Research Manager.

Requisition Number
401356668

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
1203 CLINICAL RESEARCH NURSE COORDINATOR

Job Family Level
54

Exempt/Non-Exempt
Exempt

Full Time / Part Time
FULL TIME

Regular / Temporary
Regular

Shift
First/Day

Minimum Qualifications
Duke University 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 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.

Education

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.

Experience

Twelve months of appropriate clinical nursing experience is required.

Auto req ID

95749BR

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.

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Job No:
Posted: 2/28/2018
Application Due: 4/29/2018
Work Type:
Salary: