Mngr Investigational Drug Svcs

Washington, District of Columbia-Washington
Aug 19, 2020
Sep 23, 2020
Full Time
The Manager Investigational Drug Services will develop, plan, implement, direct and evaluate activities and resources for IDS. Will be responsible for the overall direction and operational success in accordance with national standards and Children's National Medical center CRI and IRB policies and procedures. Maintain oversight of the ordering, storage, safety and control of investigational drugs. Responsible to supervise IDS personnel and coordinate investigational study support by non-IDS pharmacy personnel.


Minimum Education
Doctor of Pharmacy (Pharm.D.)

Specific Requirements and Preferences
Completion of a 5 year pharmacy program in an accredited college of Pharmacy. Completion of an ASHP accredited residency program with an advanced degree and/or significant work experience in IDS preferred. .

Specific Requirements and Preferences
3-5 years of pharmacy practice experience in a pediatric specialty, academic or clinical pharmacy setting. At least one year of supervisory experience with one or more direct reports. Practice in an IDS setting or exposure and familiarity with investigational drug products and processes preferred. .

Required Skills/Knowledge
Maintains current knowledge of all industry requirements for running an IDS by attending required training programs and/or completing CEU requirements. Ability to understand and speak English fluently and clearly. Lift 50 pounds. Ability to work independently and function in a leadership role. Organizational skills to meet deadlines and adapt to department needs. Self-motivated. Ability to work well with teams, sponsors and investigators. Experience/skill with software for word processing, spreadsheets and presentations. Excellent communication skills to include oral and written comprehension and expression. Ability and willingness to exhibit behaviors consistent with standards for performance improvement and organizational values (e.g., efficiency & financial responsibility, safety, partnership & service, teamwork, compassion, integrity, and trust & respect).

Required Licenses and Certifications
Pharmacist Licensure or eligibility for licensure in the District of Columbia is required. Licensure in the State of Virginia preferred.

Functional Accountabilities

Program Development
1. Analyze and document operational processes and problems and develop appropriate action plans.
2. Coordinate and implement solutions from process analysis and general department projects.
3. Plan and develop systems and standard operating procedures (SOPs) to improve the operating quality and efficiency of the department.
4. Responsible to assure a neat and clean working environment and develop a well-organized work routine.

Protocol and Study Management
1. Coordinate the development and implementation of treatment guidelines, research protocols, formulary changes and critical pathways as approved by appropriate committees and as evidenced by meeting minutes.
2. Receive copies of investigational and study protocols; review documents to determine if pharmaceutical material and professional services required will satisfy the study requirements.
3. Develop step-by-step procedures for preparation, dispensing and distribution of investigational and study drugs; develop codes, labels and other pre-defined formats for pharmacy computer entry.
4. Provide and assure randomization, blinding and other consultative activities to principal investigators.
5. Establish budget or fee schedule for studies and assure collection of dispensing and handling fees as appropriate.
6. Assure preparations and special formulations of investigational agents as required by protocol.

Staff Development
1. Direct staff in the development, analysis, and preparation of departmental metrics; supervise staff and performance in accordance with division policies and procedures; establish employee goals and objectives, and conduct employee performance reviews.
2. Responsible for staff scheduling to include: work assignments/rotations, employee training, employee vacations, employee breaks, overtime assignment, back up for absent employees, on-call schedules and shift rotations; coordinate with Human Resources for appropriate staffing levels and compensation; complete Human Resources paperwork as assigned.
3. Conduct interviews, hire new staff, and provide employee orientation; schedule and conduct IDS meetings; responsible to meet IDS goals and objectives; coach and provide career development advice to IDS personnel and non-IDS personnel as requested; assist staff to resolve complex operational problems; communicate with Chief of Pharmacy on IDS operations.
4. Responsible to develop staff training programs regarding investigational and study drug procedures.
5. Train professional and non-professional personnel in the preparation, labeling, record keeping, storage, safety, control and dispensing of investigational agent.
6. Train the same personnel on regulatory requirements of GCPs, GMPs, ICH guidelines, the Joint Commission and the DC Board of Pharmacy.

1. Establish and maintain a liaison relationship with the IRB and principal investigators, representing the IDS and the Division of Pharmacy on the IRB.
2. Work with Chief of Pharmacy Services and/or Clinical Pharmacy leadership and Investigators (when necessary) to establish new IDS Standard Operating Procedures and develop means to enforce such policy.
3. Meet with investigators, study monitors, and others to coordinate investigational study logistics.
4. Assist Principals Investigators, and clinical research coordinators, to establish and maintain adequate and easily retrievable record-keeping systems for protocols, study subjects, drug inventory, manufacturing, and dispensing of investigational drugs.

Record Keeping and Inventory Control
1. Ensure paperwork is completed and retained, and investigational and study drugs are handled according to the requirements of the sponsoring agencies.
2. Responsible for and assist with the development and completion of statistical reports and activity summaries on a monthly basis including monthly audits of inventory, dispensing records and files of principal investigators or study sponsors.
3. Establish and maintain standards which ensure the quality, proper storage, and safe use of all investigational agents and related supplies.
4. Assure preparation of drug monographs for nursing as needed.
5. Assure preparation of drug summary sheets and other documents for pharmacy binders and personnel.
6. Coordinate or delegate the ordering and stocking of investigational and study agents as needed to maintain adequate inventory levels.
7. Coordinate the removal and disposal of sequestered or expired stock for completed or terminated studies; ensure work is done according to protocol guidelines and division policies and procedures.

Organizational Accountabilities
Organizational Accountabilities (Leader)
Deliver 1. Set and clearly communicate team goals and priorities in alignment with departmental goals and budgets
2. Develop the budget and assign resources to meet the team goals
3. Provide the resources and guidance required for employees to perform effectively
4. Develop procedures to ensure high safety and quality, and course-correct as needed
5. Identify customers' needs and ensure service excellence in meeting those needs
Engage 1. Be the link between the department and the team in defining the strategies to meet team goals
2. Provide prompt and clear feedback to staff and support their performance
3. Ensure team adherence to organizational regulations
4. Manage the working environment to promote productivity and motivation
5. Represent the team in clearing obstacles to high performance
6. Hire staff and develop their capabilities
7. Monitor and promote strong employee engagement

Grow 1. Encourage and share new ways of making the right work easier to do
2. Recognize and share incremental improvements in operations
3. Promote the success of organizational and department initiatives by clearly aligning programs to the mission

Children's National Health System is an equal opportunity employer that evaluates qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender, identity, or other characteristics protected by law.

Similar jobs