Investigational Drug Service Clinical Research Specialist

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