Duke University Hospital is consistently rated as one of the best in the United States and is known around the world for its outstanding care and groundbreaking research.

Duke University Hospital has 1,048 licensed inpatient beds and offers comprehensive diagnostic and therapeutic facilities, including a regional emergency/trauma center; a major surgery suite containing 65 operating rooms; an endo-surgery center; a separate hospital outpatient surgical department with nine operating rooms and an extensive diagnostic and interventional radiology area.

For 2021-2022, U.S. News and World Report ranked Duke University Hospital nationally in 11 adult specialties: cancer, cardiology & heart surgery, diabetes & endocrinology, ear, nose & throat, gastroenterology & GI surgery, gynecology, neurology & neurosurgery, ophthalmology, orthopedics, pulmonology & lung surgery, and urology.

Duke University Hospital is also ranked first in North Carolina and first in the Raleigh-Durham area.

In addition to its hospitals, Duke Health has an extensive, geographically dispersed network of outpatient facilities that include primary care offices, urgent care centers, multi-specialty clinics and outpatient surgery centers.

General Description of the Job Class

As a member of the pharmacy investigational drug services team, the Clinical research specialist is responsible for operations related to all aspects of investigational drug services.

Duties and Responsibilities of this Level

• 
  Prepare Investigational Products for dispensing
  • Proactively look for study drug orders and help set up for preparation
  • Read/review study binder documents, maintain extensive certifications and trainings for specific protocols, IXRS systems and other certificates as required for the protocol:
  • pharmacy procedures
  • pharmacy manual
  • preparation worksheets
  • study protocol
• Work to ensure blinded study drug information is kept in confidence.
• USP 797 and USP 800 certification
• Work collaboratively with the IDS team to ensure timely turnaround of study start-ups and drug delivery
• Maintain and update IDS database with all required information for assigned clinical trials
• Prepare reports from Vestigo or database as requested
• Receive and file log forms ensuring all documents are printed and filed in the appropriate study binder
• Ensure study drug shipments are documented upon receipt and stored appropriately as dictated by the study procedures
  • Follow protocol-specific procedures for checking in drug shipments
  • Ensure proper temperature storage and report any excursions via the protocol provided form, follow instructionstemplatestales (return or discard, download or not, etc and reporting to company)
  • Accept via IXRS as appropriate
  • Add inventory to Vestigo
• Order and maintain all drug supplies as per the requirements of the specific study. Anticipate drug supply needs by calculating doses and cycles of therapy
• Assist the research coordinator to conduct site qualification visits and interim monitoring visits with study monitors and research coordinators
• Assist with scheduling and coordinating initiation, close-out and other study site visits
• Set-up, maintain and inventory study drug and study related materials within IDS and other satellite locations as appropriate. Resolve any discrepancies and report to the manager
• Attend on-site study initiation meetings and other relevant study education training
• Finalize study documentation including reconciliation of accountability records, return or destroy remaining study drug and prepare study records for archival
• Maintain temperature devices and logs for all pharmacy areas where study drug is stored
• Ability to work independently as well as part of the team
• Perform various administrative and clerical duties such as ordering supplies, answering calls, assisting visitors
• Help train new hires, students and residents
• Knowledge of drug names, sterile IV preparation, basic math, medical terminology, fundamental computer skills; record keeping skills
• Takes responsibility for personal and professional growth
• Works with other healthcare professionals to achieve division, departmental and institutional goals

Minimum Qualifications

Education

Associate of bachelor's degree in a scientific field preferred

Completion of a certified pharmacy technician training program

Experience

Work requires one year of experience in research or a clerical setting to become familiar with the basic techniques and methods used to collect, compile, verify and store information. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE; Prefered Minimum of two years as a pharmacy technician, including experience with IV medication preparation. Preferred hospital experience and knowledge of investigational processes

Degree, Licensure and/or Certification

Must be registered with the Board of Pharmacy. Certification in Basic Life Support

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.