Comply with EPCU Standard Operating Procedures (SOPs), Good Clinical Practices, Good Pharmacy.
Coordinate and work closely with the EPCU Pharmacist or Pharmacy Technician to ensure that IP randomization schedules, dose preparations, and other applicable work product is reviewed and approved in a timely manner.
Support the implementation and application of ClinBaseTM in the EPCU as it applies to area of responsibility.
Participate in project/client meetings to represent pharmacy services as applicable.
Act as the primary contact person representing the EPCU pharmacy for clients and external CROs.
Ensures the availability of sufficient test and reference products for study execution.
Store IP in compliance with the project protocol and EPCU SOP specifications.
Receive IP randomization schedules in a timely manner.
Manage the preparation, labeling, and dispensing of IP for dosing in a manner that is in strict compliance with the project protocol, randomization schedule, EPCU SOPs, and any other applicable regulations.
Timely and accurately deliver/ ensure availability of IP for project dosing.
Confirm clear documentation of IP receipt, IP preparation\\dispensation, IP return to the pharmacy, and IP destruction/return to the Sponsor or designee.
Oversee the storage and archiving of IP study documentation.
Ensures that IP is stored in a secure, locked location within the EPCU.
Participate in sponsor monitoring visits to represent the EPCU Pharmacy relative to project IP documentation and accountability.
Support existing and develop new pharmacy processes to ensure efficient operation of the pharmacy.
Participate in quality improvement initiatives.
Demonstrate Guest and Staff Relations standards in all activities.
The above responsibilities are a general description of the level and nature of the work assigned to this classification and is not to be considered as all inclusive.
Excellent interpersonal skills.
Detailed-oriented and ability to work creatively in a fast paced environment.
High School Matric Certificate with relevant work experience.
Pharmacy Technician or related Post Basic certification preferred or Intern Pharmacist.
Minimum Work Experience
At least 1 year experience as Pharmacy Technician or equivalent work experience.
General knowledge of generally accepted pharmacy principals, practices and procedures, pharmaceutical generic and trade names, general math, and sterile compounding.
Flexibility in work schedule to include night or weekend work may be required.
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.