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Pharmacist, PRN
CenExel is a leading nationwide clinical research site and patient network serving the life sciences industry. Leading in CNS and early phase studies, our 18 science-led Centers of Excellence deliver the right patients, at the right time, in the right place. Recently acquired by BayPine Capital Partners, our research sites provide unparalleled medical and scientific support in the design and execution of clinical trials. Our world-class PIs, advanced patient engagement strategies, premium data analytics, and integrated operations optimize every step of the clinical trial process.
Role 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.
Supervision: Reports to Medical Director
Responsibilities:
- Comply with current protocols, SOPs, GCPs, IRB and FDA guidelines
- Monitors pharmacy activities on a daily basis to ensure adherence to study protocols and dispensing procedures
- Prepare and dispense investigational drugs in accordance with the IRB-approved protocols as directed by the Principal Investigator.
- Review protocols and investigator’s brochures or other additional information supplied by the Principal Investigator and the study sponsor for CBH Health Trials clinical investigational drug trials as required.
- Provide training and professional expertise on the correct use and storage of study drug for study staff.
- Handle and maintain Investigational Product (IP) management system for receipt, accountability, storage and disposal.
- Prepare blinded study products and be responsible for emergency un-blinding, if required
- Ensure the appropriate storage of investigational drugs according to the protocol and FDA guidelines.
- Monitor temperature of pharmacy storage areas and report any temperature deviations of study drug to sponsor.
- Liaise with the PI and/or CRC to establish the pharmacy’s role for each trial which includes assignment of IP preparer, dispenser, doser, and double verifier.
- Communicate with the study team any discrepancies/violations noted during pharmacy procedures.
- Attend sponsor Investigator’s meetings, site initiations, web/teleconferences and staff meetings as needed.
- Attend pre-site selection visits, audit activities and interim monitoring visits as needed.
- Develop standard operating procedures for the pharmacy department to comply with company and regulatory requirements.
- Prepare and maintain budget for the pharmacy department.
- 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 is not to be considered as all inclusive.
- Other responsibilities as required by Medical Director.
Minimum Qualifications:
Education: Doctor of Pharmacy
Licensure and/or Certification: Licensed as Registered Pharmacist in the state of Maryland.
Experience: Minimum of 2 years related experience
Knowledge/Skills/Abilities: 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.
CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.