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The Pharmacist will coordinate and provide expertise for clinical investigational drug trials, including performing training and ensuring accurate and efficient dispensing of medication. This role maintains overall responsibility for pharmacy operations while monitoring daily activities for adherence to study protocols and dispensing procedures.
Requirements summary
Candidates must possess a Doctor of Pharmacy degree and be a Licensed Registered Pharmacist, coupled with a minimum of 2 years of related experience. Essential knowledge includes in-depth understanding of FDA regulations, GCP, and ICH guidelines, along with the ability to manage shifting priorities in a fast-paced environment.
professional certificatebachelor degreeQuality AssuranceCommunicationStaff TrainingProtocol AdherenceGCPInventory RotationSOP DevelopmentClinical TrialsFDA RegulationsPersonnel SupervisionICH GuidelinesIP ManagementIRB ProtocolsDrug DispensingInvestigational Drug ManagementBlinded Study Preparation
Job description
About Us
Each of CenExel’s research sites specialize in Phase I to Phase IV clinical trials.
Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country.
Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology.
Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability.
We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success.
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
1. Indoor, Clinic environment. 2. Essential physical requirements include sitting, typing, standing, walking. 3. Lightly active position, occasional lifting of up to 20 pounds. 4. Reporting to work, as scheduled, is essential. 5. On site work arrangement.
CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.
