Clinical Research Pharmacist (IDS)

Minimum Qualifications:


The IDS Pharmacist must be knowledgeable in standard pharmacy practices, including USP 797 and USP 800, in addition to research and oncology care practices. The IDS Pharmacist advocates for patient safety and protocol integrity, adheres to patient care standards, and communicates effectively to ensure effective conduct of clinical trials and quality patient care.

• Current Virginia Pharmacy License (required)

• Current Virginia Pharmacy Preceptor License (preferred)

• Current IV Certification (preferred)

• Current Chemotherapy Certification (preferred)

Essential Duties And Responsibilities:


Essential and other important responsibilities and duties may include but are not limited to the following:


Protocol Compliance

• Reviews potential future protocols for feasibility and attends protocol review meeting, if required.

• Attends site initiation visits, if required.

• Reviews all investigational protocols, amendments, and clarification letters. Updates concomitant medication screening note, medication diary / diaries and / or other study-specific forms and Vestigo (electronic drug accountability program) as required.

• Participates in providing timely, informative, and accurate communication with the interdisciplinary team to ensure protocol compliance and timeliness of protocol-related procedures.

• Performs concomitant medication screens on all patients who are undergoing screening for clinical trial enrollment. Answers concomitant medication questions for research staff and patients through out trial enrollment.

• Ensures evidence-based symptom management is provided to patients as permitted by the protocol.

Medication Dispensing and Preparation for Conventional and Investigational Products (IP)

• Reviews all orders for accuracy of dose and dose calculations.

• Reviews patient-specific factors to determine eligibility for treatment, including, but not limited to laboratory values, required protocol assessments (ECHO / MUGA, disease assessments, ophthalmology exam, pulmonary function, etc.), consent / reconsent and toxicity resolution.

• Develops compounding tools for all IV investigational agents and trains technicians on mixing process for all IP and conventional agents, if required.

• Have an excellent working knowledge of good clinical practice (GCP), good manufacturing practice (GMP) and all procedures, legislation or national guidelines relating to aseptic preparation (USP <797>) and dispensing of hazardous medication (USP <800>) and clinical trials.

• Assist in the provision of a high quality investigational drug service, including provision of pharmaceutical care.

• Ensure that IDS services are flexible and responsive to research staff and that the services meet patient requirements / needs.

• Provides drug information to physicians, nurses and other health care professionals.

Management of Investigational Product and Drug Accountability

• Maintains responsibility for the management of the inventory for protocols, including ordering, receiving and returning IP, as required.

• Ensure that correct procedures for receipt of IP and storage of IP are followed.

• Maintain appropriate and accurate records for all protocols, including drug accountability, drug receipt, temperature monitoring, expiration / retest dating and staff training, etc.

• Ensure that procedures for the return and disposal of IP are current and being followed.

• For oral IP: review patient medication diaries and IP returns for accuracy and completeness in conjunction with the treatment room nurses and research coordinators. Document this review and returns in Vestigo. Ensure medication diary is scanned and uploaded into eDOCs.

• Monitors IDS activities, on a daily basis, to ensure adherence to protocols and dispensing procedures.

• Ensure that products used in clinical trials are managed according to standard operating procedures (SOPs), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) and any other applicable regulations.

• Assist with monitoring visits and answering any monitor queries.

Administrative and Supervisory Responsibilities

• Provides direct supervision to IDS pharmacy technicians for preparation of medications for dispensing, including compounding of IV and hazardous medications and oral IP doses.

• Complies with NEXT Oncology SOPs and ensures all IDS staff are appropriately trained and in compliance with SOPs.

• Contributes to the development, integration and monitoring of written procedures and work flows covering all aspects of the IDS.

• Oversees monthly conventional inventory, investigates inventory discrepancies / issues and performs adjustments, as required.

• Provides technical and procedural guidance.

• Monitors IDS activities, on a daily basis, to ensure adherence to proper inventory record maintenance.

• Provides coverage for other IDS employees when they are out due to illness or scheduled PTO.

• Collects and documents workload measurement statistics, provides other data, as required.

• Supervises and provides direction to IDS staff.

• Contributes to the development of corrective and preventive action plans for unanticipated problems, deviations, violations, and issues of noncompliance.

• Provides input to performance appraisals of IDS pharmacy technicians.

• Assists the VP of Investigational Drug Services in preparation and review of documentation for audits.

Education Responsibilities

• Orients IDS staff, pharmacy residents and pharmacy students to the IDS role with respect to protocols, as required.

• Maintain continuing education requirements to maintain Pharmacy and Preceptor License, any certifications and protocol compliance training, i.e. GCP / PHRS.

• Obtain sterile compounding and hazardous compounding certification, if applicable and maintains certification.

Data and Document Management and Information Technology

• Assist in the scanning and uploading of protocol documentation into eDOCs.

• Upload resume, license(s), certification(s) and training documents into eDOCs.

• Vestigo will be utilized as our IP and protocol management software. All IDS staff will become knowledgeable in the use of this program.

PHYSICAL DEMANDS


The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Requires full range of body motion including assisting patients, manual and finger dexterity, and eye-hand coordination.

• Requires standing and walking for extensive periods of time.

• Occasionally lifts and carries items weighing up to 40 lbs.

• Requires corrected vision and hearing to normal range.

• Oversees and/or participate in daily compounding and dispensing activities associated with IDS Services.

• In addition to the above job responsibilities, other duties may be assigned.

SUPERVISION

• The IDS Pharmacist reports to the VP of Investigational Drug Services.

• The IDS Pharmacist reports to the Manager of Investigational Drug Services at their location, if applicable.