Investigational Drug Services Specialist

Brown Medicine•Cranston, RI

13d•Onsite

About The Position

SUMMARY: Reports to Pharmacy Manager, Oncology and Sterile Compounding. Under the supervision of an Investigational Drug Pharmacist performs complex pharmacy-directed technical and clerical functions to assist with coordinating operations and processes relating to investigational drug use. Collaborates closely with Investigational Drug Pharmacists to appropriately order, receive, inventory, store, prepare, package, and label investigational drug products in a manner that promotes patient safety and facilitates regulatory compliance with research study protocols and relevant state and federal guidelines including but not limited to, Rhode Island Department of Health, Rhode Island Board of Pharmacy Rules and Regulations, United States Pharmacopoeia (USP) Chapter 797 Pharmaceutical Compounding - Sterile Preparations, USP Chapter 800 Hazardous Drugs, USP Chapter 795 Pharmaceutical Compounding - Nonsterile Preparations, National Institute for Occupational Safety and Health (NIOSH), and The Joint Commission (TJC) Medication Management chapter. Brown University Health employees are expected to successfully role model the organization's values of Compassion, Accountability, Respect, and Excellence as these values guide our everyday actions with patients, customers and one another. In addition to our values, all employees are expected to demonstrate the core Success Factors which tell us how we work together and how we get things done. The core Success Factors include: Instill Trust and Value Differences Patient and Community Focus and Collaborate RESPONSIBILITIES: Under the supervision of an Investigational Drug Pharmacist, the Investigational Drug Services (IDS) Technician Specialist assists with the following: Managing operational activities such as medication receipt, storage, preparation, dispensing, and disposal per policy and study protocol guidance. Procuring investigational drugs and materials from research sponsor, drug wholesaler, and/or manufacturer in a timely fashion. Preparing investigational drugs for dispensing, and/or compounding of investigational drugs utilizing sterile or non-sterile techniques as applicable. Completing periodic investigational drug inventory, including drug expiry date and inventory audit date. Tracking temperature monitoring and other environmental controls as applicable to investigational drug storage. Documenting accountability and maintenance of complete and accurate investigational drug records. Transferring investigational drugs to off-site satellite locations, as necessary. Setting up study binders. Integrating investigational drug protocol activities between pharmacy and relevant clinical departments and study team personnel. Performing recordkeeping and filing tasks, maintaining inventory records, collating work volume statistics. Processing quarterly investigational drug services pharmacy charges. Participating in sponsor visits, audits, and investigational drug study closure visits. Sharing expertise by participating in the orientation and training of pharmacy technicians, student interns, and student externs to ensure thorough understanding of IDS policy and procedures. Participates in ongoing development of team members. Maintains supervisor awareness of personnel and team activities affecting Pharmacy IDS. Exhibits proactive problem solving to address issues impacting Pharmacy IDS. Performs all duties of other Pharmacy Technician job categories as may be required. MINIMUM QUALIFICATIONS: QUALIFICATIONS – BASIC KNOWLEDGE: High school graduate or equivalent degree required. Completion of one to two years of college preferred. Maintains current unrestricted Rhode Island Pharmacy Technician II licensure. Maintains current National Pharmacy Technician Certification (CPhT). Compounded Sterile Preparation Techniciansup®/sup(CSPTsup®/sup) Certification through Pharmacy Technician Certification Board (PTCB), iCPhT in-Dcredentialed through successful completion of the Investigational Drug Service Pharmacy Technician Course through American Association of Pharmacy Technicians, or Investigational Drug Services Certification through the American Society of Health System Pharmacy is highly desirable. QUALIFICATIONS – EXPERIENCE: Minimum 3 years’ experience as a pharmacy technician, including 2 years investigational drug or oncology and/or sterile compounding experience preferably gained in a similarly diverse and operationally complex health care environment. Knowledge of pharmacy information systems, automated dispensing technology, and personal computers. Demonstrates excellent written and verbal interpersonal and communication skills Must have the ability to multi-task and reprioritize as needed while maintaining accuracy and service standards. WORK ENVIRONMENT AND PHYSICAL REQUIREMENTS: Work may require extended periods of time spent standing and walking. Requires the visual and manual dexterity to operate a computer. May require occasional travel between affiliates and sites. INDEPENDENT ACTION: Performs independently within department policies and practices. Refers specific complex problems to supervisor where clarification of departmental policies and procedures may be required. SUPERVISORY RESPONSIBILITY: None. Pay Range: $58,489.60-$96,491.20 EEO Statement: Brown University Health is committed to providing equal employment opportunities and maintaining a work environment free from all forms of unlawful discrimination and harassment. Location: Rhode Island Hospital - 593 Eddy Street Providence, Rhode Island 02903 Work Type: M-F 7-330 or 740-4 Work Shift: Day Daily Hours: 8 hours Driving Required: No As Rhode Island's largest health system and private employer, Brown University Health is the state's premier provider of health services and includes the only Level I Trauma Center for southeastern New England. Today, more than 20,000 people work at Brown University Health and bring their unique skills, experiences, and compassion to their jobs every day. Formed in 1994, Brown University Health is a not-for-profit health system based in Providence, RI comprising three teaching hospitals of The Warren Alpert Medical School of Brown University: Rhode Island Hospital and its Hasbro Children's; The Miriam Hospital; and Bradley Hospital, the nation’s first psychiatric hospital for children; Newport Hospital, Saint Anne's Hospital and Morton Hospital, community hospitals offering a broad range of health services; Gateway Healthcare, the state’s largest provider of community behavioral health care; and Brown Health Medical Group, the largest multi-specialty practice in Rhode Island. Brown University Health is an equal opportunity employer that values diversity of cultural background, race, gender, age, religion, identity, ability, and perspectives - we are actively committed to a diverse workforce that represents the patients and community that we serve. We are invested in creating a respectful, inclusive, and equitable environment that supports the holistic well-being of our employees and their families. Join us and help build a healthier future for our patients - and for yourself. Company Location Belonging and Engagement Nursing Our Mission

Requirements

High school graduate or equivalent degree required.
Maintains current unrestricted Rhode Island Pharmacy Technician II licensure.
Maintains current National Pharmacy Technician Certification (CPhT).
Minimum 3 years’ experience as a pharmacy technician, including 2 years investigational drug or oncology and/or sterile compounding experience preferably gained in a similarly diverse and operationally complex health care environment.
Knowledge of pharmacy information systems, automated dispensing technology, and personal computers.
Demonstrates excellent written and verbal interpersonal and communication skills
Must have the ability to multi-task and reprioritize as needed while maintaining accuracy and service standards.

Nice To Haves

Completion of one to two years of college preferred.
Compounded Sterile Preparation Techniciansup®/sup(CSPTsup®/sup) Certification through Pharmacy Technician Certification Board (PTCB), iCPhT in-Dcredentialed through successful completion of the Investigational Drug Service Pharmacy Technician Course through American Association of Pharmacy Technicians, or Investigational Drug Services Certification through the American Society of Health System Pharmacy is highly desirable.

Responsibilities

Managing operational activities such as medication receipt, storage, preparation, dispensing, and disposal per policy and study protocol guidance.
Procuring investigational drugs and materials from research sponsor, drug wholesaler, and/or manufacturer in a timely fashion.
Preparing investigational drugs for dispensing, and/or compounding of investigational drugs utilizing sterile or non-sterile techniques as applicable.
Completing periodic investigational drug inventory, including drug expiry date and inventory audit date.
Tracking temperature monitoring and other environmental controls as applicable to investigational drug storage.
Documenting accountability and maintenance of complete and accurate investigational drug records.
Transferring investigational drugs to off-site satellite locations, as necessary.
Setting up study binders.
Integrating investigational drug protocol activities between pharmacy and relevant clinical departments and study team personnel.
Performing recordkeeping and filing tasks, maintaining inventory records, collating work volume statistics.
Processing quarterly investigational drug services pharmacy charges.
Participating in sponsor visits, audits, and investigational drug study closure visits.
Sharing expertise by participating in the orientation and training of pharmacy technicians, student interns, and student externs to ensure thorough understanding of IDS policy and procedures.
Participates in ongoing development of team members.
Maintains supervisor awareness of personnel and team activities affecting Pharmacy IDS.
Exhibits proactive problem solving to address issues impacting Pharmacy IDS.
Performs all duties of other Pharmacy Technician job categories as may be required.