Job Summary: The Pharmacist shall coordinate, collaborate and provide expertise in support of clinical investigational drug trials; perform training responsibilities; provide accurate and efficient dispensing of medication; perform administrative responsibilities; maintain overall responsibility for pharmacy operations; perform cross functional duties as required.
Essential Responsibilities and Duties:- Monitors pharmacy activities on a daily basis to ensure adherence to study protocols and dispensing procedures.
- Prepares and dispenses investigational drugs in accordance with the IRB-approved protocols as directed by the Principal Investigator.
- Reviews protocols and investigator's brochures or other additional information supplied by the Principal Investigator and the study sponsor for clinical investigational drug trials as required.
- Provides training and professional expertise on the correct use and storage of study drug for study staff.
- Handles and maintains Investigational Product (IP) management system for receipt, accountability, storage and disposal.
- Prepares blinded study products and be responsible for emergency un-blinding, if required.
- Ensures the appropriate storage of investigational drugs according to the protocol and FDA guidelines.
- Monitors temperature of pharmacy storage areas and report any temperature deviations of study drug to sponsor.
- Monitors and Rotates stock to ensure use before expiration date.
- Communicates with the study team any discrepancies/violations noted during pharmacy procedures.
- Attends sponsor Investigator's meetings, site initiations, web/teleconferences and staff meetings as needed.
- Develops standard operating procedures for the pharmacy department to comply with company and regulatory requirements.
- Hires, trains, supervises, and evaluates personnel. Champions and enforces the strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site Working Practices, protocol, and company guidelines and policies. Retrains and implements corrective and preventative actions, as needed.
- Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.
Education/Experience/Skills:- Must be able to effectively communicate verbally and in writing.
- Doctor of Pharmacy
- Licensed as Registered Pharmacist
- Minimum of 2 years related experience
- Prior experience in clinical research, preferred.
- Must have in depth knowledge of FDA regulations, GCP, and ICH guidelines; Able to take a flexible approach to shifting priorities; Able to manage multiple projects and responsibilities; Motivated to work consistently in a fast paced and rapidly changing environment.
Working Conditions - Indoor, Clinic environment.
- Essential physical requirements include sitting, typing, standing, walking.
- Lightly active position, occasional lifting of up to 20 pounds.
- Reporting to work, as scheduled, is essential.
- On site work arrangement.
