Investigational Drug Service Clinical Research Specialist

Responsibilities

• 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

Preferred

• Pharmacy technician experience preferred
• Clinical research experience preferred
• Medication terminology knowledge preferred
• 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
• Glassdoor
• 3.7
• As a world-class academic and health care system, Duke Health strives to transform medicine and health locally and globally through innovative scientific research, rapid translation of breakthrough discoveries, educating future clinical and scientific leaders, advocating and practicing evidence-based medicine to improve community health, and leading efforts to eliminate health inequalities.
• Durham, North Carolina, USA
• http://dukemedicine.org
• H1B Sponsorship
• Data Powered by
• Distribution of Different Job Fields Receiving Sponsorship
• Represents job field similar to this job
• Customer Service and Support
• Engineering and Development
• Education and Training
• Management and Executive
• Trends of Total Sponsorships

Qualifications

• Work requires knowledge of basic mathematical, data collection and research principles normally acquired through an associate's degree
• 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
• Data entry/CRT
• Typing-medical
• Editing/proofing
• Medical terminology
• Correspondence
• Data verification
• Data coding-general
• PC Wordprocessing software
• PC database MGT software
• Pharmacy technician experience preferred
• Clinical research experience preferred
• Medication terminology knowledge preferred
• 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
• 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.

Required skills

• Aseptic Technique, Clinical Research, Data Coding, Data Entry, Data Verification, Medical Terminology, North Carolina Pharmacy Technician License, PC Database Management Software, PC Word Processing Software, Pharmacy Technician Certification ExCPT, Pharmacy Technician Certification PTCB, TempTrak, Vestigo

Preferred skills

• (10), (12), (17), (24), (30), (39), *2026, 12, 2020, 2021, 2022, 2023, 2024, 2025, 3.7, Clinical research experience preferred, Customer Service and Support, Data Powered by, Distribution of Different Job Fields Receiving Sponsorship, Durham, North Carolina, USA, Education and Training, Engineering and Development, Glassdoor, H1B Sponsorship, Management and Executive, Medication terminology knowledge preferred, Pharmacy technician experience preferred, Represents job field similar to this job, Trends of Total Sponsorships, http://dukemedicine.org

Experience

• 1+ years