Biotrial, a leading provider of high-quality pharmacology services , is currently recruiting a Per Diem Clinical Research Pharmacist for its U.S. headquarters in Newark, New Jersey. This position will work 2-3 days per week, 4 hours a day.
With over 30 years of experience in providing scientific and medical services in Early Clinical Development, Biotrial possesses one of the largest clinical capacities in Europe. The company’s 60,000 sq. ft., 110-bed, state-of-the art Clinical Pharmacology Unit is in the heart of University Heights Science Park, attached to Rutgers/NJMS and the University Hospital.
Summary:
The Clinical Research Pharmacist is responsible for effective pharmacy operations in accordance with Good Clinical Practices and regulatory requirements.
Responsibilities:
- Participate in the daily operations in the pharmacy: supply, storage, packaging, re-labeling, dispensing, accountability, returning or destruction of OTCs or investigational drugs.
- Draft and/or review the study specific pharmacy procedures/ pharmacy manuals and act as technical advisor to the clinical teams and other departments within Clinical Pharmacology.
- Supervise and prepare the IMPs for dosing in accordance with the Protocol and the legislation in effect.
- Help prepare the Trial Master Files of each study in collaboration with the Clinical staff.
- Manage the randomization codes.
- Perform or oversee the extemporaneous reconstitution of IV/SC drugs under laminar flow hood and oral solutions.
- Manage the equipment and medications in the crash carts.
- Assist operations and client managers with Sponsor audits, initiation and monitoring visits, and other interactions as appropriate.
- Follow internal SOPs and the current Good Clinical Practices, etc.
- Ensure the pharmacy facilities and processes are compliant with most recent regulations/guidelines and interact with regulatory bodies relevant to the pharmacy department.
- Work in close collaboration with the clinical teams (investigators, nurses, technicians, etc.) and the project management team.
- Track the monitoring of the temperature / hygrometry in the pharmacy areas.
- Monitor the hygiene in the pharmacy (Bio-cleaning, control of microbial contamination of surfaces).
- Ensure that the pharmacy SOPs are accurate and up to date.
Requirements:
- Registered Pharmacist/Pharm D with active license in NJ.
- 3-4 years pharmacy practice experience; preferably in a CRO.
- IV Sterile Experience.
- Very good understanding of the Drug Development Process and applicable regulations.
- Exceptional attention to detail.
- Excellent communication skills (interpersonal, written, verbal).
- Excellent knowledge of Microsoft Office Suite including Word and Excel.
- Ability to read, analyze and interpret the most complex documents.
- Ability to work independently, efficiently and accurately with high productivity.
- Experience in conducting complex long-term projects and meeting strict timelines.
Biotrial is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, genetics, disability, age, veteran status, or any other characteristic protected by law.
Work Remotely
Benefit Conditions:
- Waiting period may apply
- Only full-time employees eligible
Work Remotely
Job Type: Part-time
Schedule:
Application Question(s):
- What days of the week and hours are you able to work?
Education:
Experience:
- Pharmacy: 3 years (Preferred)
License/Certification:
- New Jersey Licensed Pharmacist (Required)
Work Location: In person