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Pharmacist - Clinical Research
1 month ago
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.
Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.
Hourly Range: TBD
DUTIES AND RESPONSIBILITIES DESCRIPTION
- Comply with current protocols, SOPs, GCPs, IRB and FDA guidelines.
- Monitors pharmacy activities daily 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 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.
- 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.
- 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 are not to be considered as all inclusive.
- Must be able to effectively communicate verbally and in writing.
- Doctor of Pharmacy
- Licensed as Registered Pharmacist
- Minimum of 2 years related experience
- 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.
- 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.
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
