Duke University
Clinical Research Specialist - Investigational Drug Services
Duke University, Durham, North Carolina, United States, 27703
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 and is the number one hospital in North Carolina, according to U.S. News and World Report for 2023-2024. Duke University Hospital is the largest of Duke Health's three hospitals and features 1048 patient beds, 65 operating rooms, as well as comprehensive diagnostic and therapeutic facilities, including a regional emergency/trauma center, an endo-surgery center, and more.
Practice or research specialty/focus of the position:
Investigational Drug Service (ICS) - Oncology
Working Hours : 8:30 am - 5:00 pm
Position Summary:
A Clinical Research Specialist position in the Investigational Chemotherapy Service is immediately available. This individual performs, under supervision, a variety of duties related to the procurement, preparation, distribution, and storage of investigational chemotherapy for clinical research studies conducted by principal investigator(s) at Duke University Health System across different therapeutic areas and phases, in accordance to appropriate regulations, Standard Operating Procedures (SOPs), and study-specific protocols/plans and processes. The successful candidate must possess strong drug preparation and customer service skills and be organized and detail-oriented. This position has many exciting and challenging responsibilities, which include:
Accurately and efficiently follow workflow procedures including investigational drug order processing, preparation, and distribution to clinical research staff and participantsPrepare investigational medication for both pediatric and adult research participants including orals prescriptions and parenteral medications using aseptic techniqueHandle medications in accordance with ICS SOPs, study-specific pharmacy manuals and protocol summaries, and department, regulatory and legal requirementsReceive shipments of investigational drugs provided by study sponsors and record appropriately within Vestigo and sponsor systems as neededCollect and accurately document participant returns of hazardous and non-hazardous oral investigational drugs for compliance analysisShip investigational medication to outside institutions and patients as requiredDeliver investigational agents and supplies to patient care areas and to the courier service providers as neededTransport internally-ordered investigational agents from the Duke pharmacy storeroom to ICSConduct routine inventory counts for each investigational drug in order to ensure that the physical quantity on hand corresponds to the quantities recorded on the drug accountability record form (DARF)Appropriately file source documentation related to investigational drugs, including drug receipts, prescription orders, and work labelsParticipate in activities of an investigational drug service, including inventory management and locating of source documentation for monitoring visits and sponsor auditsComplete training as required for key research personnelEfficient operation and basic level of technical support for specialty machinery, equipment, devices or software necessary in performing job functions (e.g., Vestigo software, temperature monitoring devices, label printers)Restock auxiliary supplies as neededAnswer and screen telephones calls and directs calls to appropriate personnel when neededManage individual responsibilities while supporting the ICS team and contributing to broader team goalsTake responsibility for personal and professional growthOther duties as requestedRequired Qualifications at this LevelEducation
Work requires knowledge of basic mathematical, data collection and research principles normally acquired through an associate's degree.Work requires a high school diploma or equivalent and one year of pharmacy or health care-related experience or a high school diploma and completion of an accredited pharmacy technician training program.Completion of an Associate's degree preferredExperience
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.Minimum of one year of closely-related pharmacy technician experience preferredDegrees, Licensure, and/or Certification
N/AKnowledge, Skills, and Abilities
DATA ENTRY/CRTTYPING-MEDICALEDITING/PROOFINGMEDICAL TERMINOLOGYCORRESPONDENCEDATA VERIFICATIONDATA CODING-GENERALPC WORDPROCESSING SOFTWAREPC DATABASE MGT SOFTWAREDistinguishing Characteristics of this LevelN/A
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.
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 and is the number one hospital in North Carolina, according to U.S. News and World Report for 2023-2024. Duke University Hospital is the largest of Duke Health's three hospitals and features 1048 patient beds, 65 operating rooms, as well as comprehensive diagnostic and therapeutic facilities, including a regional emergency/trauma center, an endo-surgery center, and more.
Practice or research specialty/focus of the position:
Investigational Drug Service (ICS) - Oncology
Working Hours : 8:30 am - 5:00 pm
Position Summary:
A Clinical Research Specialist position in the Investigational Chemotherapy Service is immediately available. This individual performs, under supervision, a variety of duties related to the procurement, preparation, distribution, and storage of investigational chemotherapy for clinical research studies conducted by principal investigator(s) at Duke University Health System across different therapeutic areas and phases, in accordance to appropriate regulations, Standard Operating Procedures (SOPs), and study-specific protocols/plans and processes. The successful candidate must possess strong drug preparation and customer service skills and be organized and detail-oriented. This position has many exciting and challenging responsibilities, which include:
Accurately and efficiently follow workflow procedures including investigational drug order processing, preparation, and distribution to clinical research staff and participantsPrepare investigational medication for both pediatric and adult research participants including orals prescriptions and parenteral medications using aseptic techniqueHandle medications in accordance with ICS SOPs, study-specific pharmacy manuals and protocol summaries, and department, regulatory and legal requirementsReceive shipments of investigational drugs provided by study sponsors and record appropriately within Vestigo and sponsor systems as neededCollect and accurately document participant returns of hazardous and non-hazardous oral investigational drugs for compliance analysisShip investigational medication to outside institutions and patients as requiredDeliver investigational agents and supplies to patient care areas and to the courier service providers as neededTransport internally-ordered investigational agents from the Duke pharmacy storeroom to ICSConduct routine inventory counts for each investigational drug in order to ensure that the physical quantity on hand corresponds to the quantities recorded on the drug accountability record form (DARF)Appropriately file source documentation related to investigational drugs, including drug receipts, prescription orders, and work labelsParticipate in activities of an investigational drug service, including inventory management and locating of source documentation for monitoring visits and sponsor auditsComplete training as required for key research personnelEfficient operation and basic level of technical support for specialty machinery, equipment, devices or software necessary in performing job functions (e.g., Vestigo software, temperature monitoring devices, label printers)Restock auxiliary supplies as neededAnswer and screen telephones calls and directs calls to appropriate personnel when neededManage individual responsibilities while supporting the ICS team and contributing to broader team goalsTake responsibility for personal and professional growthOther duties as requestedRequired Qualifications at this LevelEducation
Work requires knowledge of basic mathematical, data collection and research principles normally acquired through an associate's degree.Work requires a high school diploma or equivalent and one year of pharmacy or health care-related experience or a high school diploma and completion of an accredited pharmacy technician training program.Completion of an Associate's degree preferredExperience
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.Minimum of one year of closely-related pharmacy technician experience preferredDegrees, Licensure, and/or Certification
N/AKnowledge, Skills, and Abilities
DATA ENTRY/CRTTYPING-MEDICALEDITING/PROOFINGMEDICAL TERMINOLOGYCORRESPONDENCEDATA VERIFICATIONDATA CODING-GENERALPC WORDPROCESSING SOFTWAREPC DATABASE MGT SOFTWAREDistinguishing Characteristics of this LevelN/A
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.