Investigigational Drug Service Clinical Research Specialist
Duke University
Investigigational Drug Service Clinical Research Specialist
Duke University
Private research university in Durham, NC
At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advance health together.
About Duke University Hospital
Pursue your passion for caring with Duke University Hospital in Durham, North Carolina, which is consistently ranked among the best in the United States. The largest of the four Duke Healthhospitals with 1062 patient beds, it features comprehensive diagnostic and therapeutic facilities, including a regional emergency/trauma center, an endo-surgery center, and more.
Schedule
Weekdays
Day shift
No holidays
No on-call
Duties and Responsibilities of this Level
The IDS Clinical Research Specialist (CRS) is an integral member of the research pharmacy team whose primary role is to manage the entire inventory of investigational product (IP) for every research protocol. In addition, the CRS is responsible for the safe, compliant and protocol-driven handling of IP in clinical trials, ensuring patient safety, regulatory adherence, study integrity and full IP accountability records.
Receive investigational product shipments for 300+ research protocols
Document receipt of each shipment via sponsor acknowledgement of receipt form or email (as requested by sponsor)
Upload temperature tracker data for each shipment (per sponsor)
Evaluate temperature tracker data to determine suitability of use for received IP
Report any shipping issues to sponsors (temperature deviation, breakage, etc.)
Communicate with shipping companies to obtain missing invoices or other IP documentation
Communicate with sponsors as needed for any IP issues or concerns
Maintain electronic documentation of all shipments/invoices/temperature data/retest dates (local drive and Vestigo)
Document all correspondence with shippers and/or sponsors
Enter each shipment into Vestigo inventory by protocol
Ensure accuracy of each IP vial/syringe/kit/bottle number entered into Vestigo
Perform monthly IP expiration check with sponsors for expiring medications
Obtain and upload TempTrak data for all refrigerators, freezers and ambient storage areas at the beginning of each month
Perform manual temperature monitoring as needed per protocol or sponsor
Prepare designated study storage bins for each study
Assist in the reporting of temperature excursions or product complaints
Assist in the destruction or return of study IP per sponsor
Work with pharmacists to perform all non-sterile dispensing for all studies
Work with study teams to obtain required information for dispensing
Use aseptic technique to pull up IM/SC dispenses per protocol
Assist primary IV technician in the preparation of sterile IV doses as needed
Adhere to dispensing procedures to correctly prepare and dispense all IP per protocol
Assist with monitoring visits and Vestigo access as needed
Required Qualifications at this Level
Education
Work requires knowledge of basic mathematical, data collection and research principles normally acquired through an associate's degree.
Experience:
Work requires one year 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 Equivalent combination of relevant education and/or experience.
Pharmacy technician experience preferred
Clinical research experience preferred
Medication terminology knowledge preferred
Degrees, Licensure, and/or Certification:
Pharmacy Technician certification from the Pharmacy Technician Certification Board (PTCB) or The Exam for the Certification of Pharmacy Technicians (ExCPT) preferred
Pharmacy Technician license from the North Carolina Board of Pharmacy preferred
Knowledge, Skills, and Abilities:
Data entry/CRT
Typing-medical
Editing/proofing
Medical terminology
Correspondence
Data verification
Data coding-general
PC Wordprocessing software
PC database MGT software
Duke is an 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 (including pregnancy and pregnancy related conditions), sexual orientation or military 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.
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.
Private research university in Durham, NC
Duke University is a research university offering undergraduate, graduate, and professional education alongside interdisciplinary research and health care.
Explore more opportunities at Duke University