Clinical Research Specialist - Pharmacy

Duke University; Durham (NC); On-site; USD 45,000 - 60,000; Full time

Job summary

Duke University Hospital seeks a Clinical Research Specialist to support investigational chemotherapy services. The role involves drug preparation, compliance with regulations, and collaboration with clinical research staff. Candidates should have an Associate's degree and relevant experience, with a focus on detail and customer service.

Qualifications

• Knowledge of basic mathematical, data collection, and research principles.
• One year of experience in a research or clerical setting.
• Completion of an accredited pharmacy technician-training program preferred.

Responsibilities

• Prepare investigational medication for research participants.
• Accurately follow workflow procedures for drug processing.
• Conduct routine inventory counts for investigational drugs.

Skills

Drug preparation

Customer service

Attention to detail

Education

Associate's degree

Tools

Vestigo software

Job description

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 Duke Health's four hospitals with 1062 patient beds, it features comprehensive diagnostic and therapeutic facilities, including a regional emergency/trauma center, an endo-surgery center, and more.

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 participants
• Prepare investigational medication for both pediatric and adult research participants including orals prescriptions and parenteral medications using aseptic technique
• Handle medications in accordance with ICS SOPs, study-specific pharmacy manuals and protocol summaries, and department, regulatory and legal requirements
• Receive shipments of investigational drugs provided by study sponsors and record appropriately within Vestigo and sponsor systems as needed
• Collect and accurately document participant returns of hazardous and non-hazardous oral investigational drugs for compliance analysis
• Ship investigational medication to other Duke institutions and patients as required
• Deliver investigational agents and supplies to patient care areas and to the courier service providers as needed
• Transport internally-ordered investigational agents from the Duke pharmacy storeroom to ICS
• Conduct routine inventory counts for each investigational drug 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 labels
• Participate in activities of an investigational drug service, including inventory management and locating source documentation for monitoring visits and sponsor audits
• Complete training as required for key research personnel
• Efficient 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 needed
• Answer and screen telephones calls and directs calls to appropriate personnel when needed
• Manage individual responsibilities while supporting the ICS team and contributing to broader team goals
• Take responsibility for personal and professional growth
• Other duties as requested

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 of experience in research or a clerical setting to familiarize one with the basic techniques used to collect, compile, verify, and store information.

OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE. Preferred one year of pharmacy or health care related experience, completion of an accredited pharmacy technician-training program (PTCB Certification or completed within 6 months of starting position). A minimum of one year of closely related pharmacy technician experience.

Preference given to those with considerable knowledge of oncology drug preparation, medical terminology, and pharmaceutical calculations.

Job Code: 00004029 CLINICAL RESEARCH SPECIALIST
Job Level: D2

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.

Essential Physical Job Functions: 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.