Clinical Pharmacist - Oncology Investigational Drug Services

Duke Careers•Durham, NC

1d•Onsite

About The Position

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.Working hours: Weekdays Day shift 40 hours/week Practice or research specialty/focus of the position: Oncology Investigational Drug Service Position Summary: A clinical pharmacist position in the Oncology Investigational Drug Service (Onc IDS) is immediately available. Candidates must possess excellent writing, organizational, analytic, clinical and interpersonal skills. This clinical pharmacist position has many exciting and challenging responsibilities, the major ones include: Attend Duke Office of Clinical Research study start up meetings and advise investigators and research coordinators regarding ICS services and any anticipated budget/resource requirements Attend activities related to protocol setup including but not limited to, drug information gathering, protocol review and logistic assessment, attending site initiative visits, and writing study-specific procedures and drug data Review all protocols and Onc IDS procedures for investigational products (IPs) that Onc IDS will dispense Prepare protocol specific procedures for safe and appropriate investigational drug product use, blinding, accountability, procurement, storage, preparation, dispensing, destruction, budgeting, and billing Verify investigational drug orders after reviewing patient charts for dosing and evaluation of drug toxicity (labs, drug-drug interactions, adverse event documentation) and appropriateness of dosing investigational product Provide education to pharmacists and other health care professionals about studies occurring in their areas Create EPIC electronic drug build templates and validate electronic drug builds for all sponsor provided IPs for research protocols utilizing Onc IDS Assist in the validation of research EPIC Beacon treatment plans for all protocols utilizing Onc IDS Ensure personal and departmental regulatory compliance for all research protocols by adhering to Federal, Good Clinical Practice, Joint Commission, and NCI requirements Provide specialized pharmaceutical research services to improve study integrity and outcomes Participate in protocol maintenance including but not limited to reviewing protocol amendments, participating in monitoring visits and audits with study sponsor, the FDA, Office of regulatory Affairs and Quality (ORAQ), or other regulating bodies, and triaging protocol-specific issues Monitor investigational inventory and manually reorder medications as needed through clinical trial conduct Receive IP shipments and record IP receipt appropriately in Vestigo and Interactive Response Technology Systems as needed. Interface and communicate with representatives of regulatory agencies and pharmaceutical research sponsors Protocol Review and Monitoring Committee (PRMC) membership, participating in monthly meetings Serve as a resource for physicians and pharmacists for all aspects of the clinical research processes and use of non-approved drugs under a compassionate use basis Oversee and assist with the preparation and dispensing of oral and parenteral investigational products while abiding by departmental SOPs Dispense investigational products which includes dispensing and shipping to satellite sites Maintain complete and accurate accountability records for investigational products to comply with all good clinical practice guidelines to assure the data and reported results are credible and valid and aid in investigational product approval Participate in monthly on-call coverage for investigational chemotherapy service Contribute to student and resident education, including serving as a preceptor for APPE students and PGY2 oncology residents Maintain familiarity with all departmental programs and work as integral part of the pharmacy team Work cooperatively within department and with other departments to achieve division and departmental goals Respond quickly and appropriately to customer requests and treats customers with courtesy, respect and caring behaviors Anticipates customer needs and initiates action to meet those needs Identify areas of development and seek opportunities for personal and professional growth Coordinate and oversee routine maintenance on equipment as indicated by manufacturers recommendations and policy Will know, understand, and abide by all Pharmacy Department and Onc IDS Policies and Procedures Other duties as assigned

Requirements

Doctor of Pharmacy Degree or BS Pharmacy Degree
With a BS Pharmacy degree, two years of pharmacy practice experience, or acceptable board certification, or completion of an accredited residency program and demonstrated ability to achieve positive patient outcomes in a similar environment is required.
With Doctor of Pharmacy degree, no experience is required.
Licensed Pharmacist or eligible to practice pharmacy in North Carolina

Nice To Haves

2-5 years of hospital or PGY-1 Residency preferred
Research and/or oncology experience preferred

Responsibilities

Attend Duke Office of Clinical Research study start up meetings and advise investigators and research coordinators regarding ICS services and any anticipated budget/resource requirements
Attend activities related to protocol setup including but not limited to, drug information gathering, protocol review and logistic assessment, attending site initiative visits, and writing study-specific procedures and drug data
Review all protocols and Onc IDS procedures for investigational products (IPs) that Onc IDS will dispense
Prepare protocol specific procedures for safe and appropriate investigational drug product use, blinding, accountability, procurement, storage, preparation, dispensing, destruction, budgeting, and billing
Verify investigational drug orders after reviewing patient charts for dosing and evaluation of drug toxicity (labs, drug-drug interactions, adverse event documentation) and appropriateness of dosing investigational product
Provide education to pharmacists and other health care professionals about studies occurring in their areas
Create EPIC electronic drug build templates and validate electronic drug builds for all sponsor provided IPs for research protocols utilizing Onc IDS
Assist in the validation of research EPIC Beacon treatment plans for all protocols utilizing Onc IDS
Ensure personal and departmental regulatory compliance for all research protocols by adhering to Federal, Good Clinical Practice, Joint Commission, and NCI requirements
Provide specialized pharmaceutical research services to improve study integrity and outcomes
Participate in protocol maintenance including but not limited to reviewing protocol amendments, participating in monitoring visits and audits with study sponsor, the FDA, Office of regulatory Affairs and Quality (ORAQ), or other regulating bodies, and triaging protocol-specific issues
Monitor investigational inventory and manually reorder medications as needed through clinical trial conduct
Receive IP shipments and record IP receipt appropriately in Vestigo and Interactive Response Technology Systems as needed.
Interface and communicate with representatives of regulatory agencies and pharmaceutical research sponsors
Protocol Review and Monitoring Committee (PRMC) membership, participating in monthly meetings
Serve as a resource for physicians and pharmacists for all aspects of the clinical research processes and use of non-approved drugs under a compassionate use basis
Oversee and assist with the preparation and dispensing of oral and parenteral investigational products while abiding by departmental SOPs
Dispense investigational products which includes dispensing and shipping to satellite sites
Maintain complete and accurate accountability records for investigational products to comply with all good clinical practice guidelines to assure the data and reported results are credible and valid and aid in investigational product approval
Participate in monthly on-call coverage for investigational chemotherapy service
Contribute to student and resident education, including serving as a preceptor for APPE students and PGY2 oncology residents
Maintain familiarity with all departmental programs and work as integral part of the pharmacy team
Work cooperatively within department and with other departments to achieve division and departmental goals
Respond quickly and appropriately to customer requests and treats customers with courtesy, respect and caring behaviors
Anticipates customer needs and initiates action to meet those needs
Identify areas of development and seek opportunities for personal and professional growth
Coordinate and oversee routine maintenance on equipment as indicated by manufacturers recommendations and policy
Will know, understand, and abide by all Pharmacy Department and Onc IDS Policies and Procedures
Other duties as assigned