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Pharmacy Coord Investigational Drug Services

4 months ago

Providence, United States Lifespan Full time

Summary:

Reports to the Manager Oncology and Sterile Compounding. Responsible for demonstrating clinical and operational knowledge and expertise as it relates to investigational drug services (IDS). Manages coordinates and oversees all aspects of investigational drug studies in the clinical practice setting. Collaborates with interdisciplinary program leaders to coordinate and lead investigational drug services. Develops and executes quality initiatives to detect mitigate and prevent medication adverse events. Oversees medication safety systems patient quality and outcomes programs and regulatory compliance assurance as they relate to investigational drug services. Serves as departmental clinical resource and liaison to practitioners pharmacists nurses and other personnel regarding investigational drugs and clinical trials. Participates in the development and implementation of pharmacy policies procedures and budgets for investigational drug studies in the clinical practice setting.

Lifespan employees are expected to embrace Lifespan's mission of "Delivering health with care" and successfully role model Lifespan's values of Compassion Accountability Respect and Excellence as this guides our everyday actions with patients customers and one another.

Responsibilities:

Serves as a member of the Investigational Review Board (IRB) and the liaison between the IRB IDS and the Pharmacy Department.

Serves as clinical resource for investigational drug studies and protocols.

Communicates with practitioners pharmacists nurses and other personnel regarding questions and clarifications on investigational drug study protocols.

Communicates with investigators study sponsors and clinical monitors regarding clinical trials and investigational drugs.

Oversees and coordinates the protocol build process for investigational drugs monitors drug therapy based on protocol.

Facilitates the development and implementation of evidence-based treatment guidelines protocols and critical pathways as approved by appropriate committees.

Assists investigators with the development of the investigational drug information section for investigational protocols and with submission implementation and coordination of investigational drug protocols.

Develops and implements in-service training for pharmacists nurses and other stakeholders including preparation labeling administration and safe handling of investigational study drugs. Facilitates the dissemination of investigational drug study information through the IDS blog.

Participates in the development of tools and standards to establish and improve competency level of IDS staff.

Reviews drug-related information used in the informed consent process.

Assists with the development and implementation of pharmacy policies and procedures related to IDS.

Oversees the creation of study binders and addition of protocol and drug information into the Investigational Management System (nCoup).

Develops and implements quality assessment and quality improvement measures to improve patient care and staff efficiency related to IDS. Monitors outcomes.

Assures requirements of manufacturer FDA and IRB approved research protocols are met throughout the study and ensures complete documentation in nCoup.

Oversees study sponsor visits audits and study close-out visits.

Evaluates and recommends technologies physical designs procedures and techniques to maintain compliance with United States Pharmacopoeia (USP) Chapter Pharmaceutical Compounding Sterile Preparations USP Chapter Hazardous Drugs National Institute for Occupational Safety and Health (NIOSH) and The Joint Commission (TJC) Medication Management chapter.

Assesses feasibility of IDS collaboration in proposed investigational drug studies. If feasible prepares letter of collaboration and IDS budget.

Communicates and presents information effectively in both oral and written form to all levels of health care providers and to patients families and caregivers.

Schedules clinical pharmacist specialists IDS organizes and prioritizes work assignments.

Collaborates with investigators and sponsors to anticipate investigational drug usage to ensure adequate on-hand inventory.

Ensures investigational drugs are stored inventoried and disposed of properly and that the required documentation is complete and accurate.

Oversees transfers of investigational study drugs to off-site satellite locations.

Maintains appropriate pricing for IDS in investigational drug studies and evaluates pricing annually. Oversees IDS pharmacy charging processes.

Contributes to annual performance appraisal process for Clinical Pharmacist Specialist IDS team members.

Interviews and provides input to the hiring of potential IDS team members. Coordinates training and on-boarding of new IDS employees.

Precepts evaluates and serves as a mentor to pharmacy learners including PGY1 and PGY2 residents and Advanced Pharmacy Practice Experience (APPE) students.

Develops and implements quality assessment and quality improvement measures to improve patient care and staff efficiency related to IDS. Monitors outcomes.

Demonstrates knowledge and skills necessary to provide care to neonate child adolescent adult and geriatric patients with consideration of aging processes human development stages and cultural patterns in each step of the care process.

Sustains professional competence and promotes development through participation in in-services workshops seminars and professional organizations. Attends and participates in local regional and national programs and meetings regarding investigational protocol studies.

Performs other duties as assigned by Manager Oncology and Sterile Compounding.

Other information:

BASIC KNOWLEDGE:

Bachelor of Science in Pharmacy or Doctor of Pharmacy degree from an accredited college of pharmacy.

Prior to start date possesses current unrestricted licensure as a licensed pharmacist or as a licensed 90-day temporary pharmacist in the State of Rhode Island. Obtains full licensure prior to expiration of 90-day temporary pharmacist license then possesses and maintains current unrestricted licensure as licensed pharmacist in the State of Rhode Island.

American Society of Health System Pharmacists (ASHP) Investigational Drug Certificate is desirable.

EXPERIENCE:

Five years progressively more responsible related experience including 2 years of investigational drug oncology or sterile compounding experience preferably gained in a similarly diverse and operationally complex integrated health care system.

Successful completion of a PGY2 residency in Investigational Drugs and Research or PGY2 residency in Oncology highly desirable or Board-Certified Oncology Pharmacist (BCOP).

WORK ENVIRONMENT AND PHYSICAL REQUIREMENTS:

Requires the visual acuity and manual dexterity necessary to operate a computer and use a typical keyboard and computer mouse to navigate screens on multiple computer monitors.

Extended periods of time spent standing and walking.

May require occasional travel between affiliates and sites.

INDEPENDENT ACTION:

Performs independently within a broad scope of departmental policies and practices.

Refers specific complex problems to Manager when clarification of departmental policies and procedures may be required.

SUPERVISORY RESPONSIBILITY:

None.

Lifespan is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race color religion sex national origin age ethnicity sexual orientation ancestry genetics gender identity or expression disability protected veteran or marital status.   Lifespan is a VEVRAA Federal Contractor.

Location: Rhode Island Hospital USA:RI:Providence

Work Type: Full Time

Shift: Shift 1

Union: Non-Union