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Clinical Pharmacy Supervisor
2 months ago
Position: Clinical Pharmacy Supervisor / Pharmaceutical Research Coordinator
Reporting To: Associate Director, Clinical Operations
Supervision: Pharmacy Technicians
Qualifications: A Bachelor's degree in a scientific field or equivalent professional experience is required. Experience: At least 2 years as a registered Pharmacy Technician is essential, with additional experience in preparing investigational medications for clinical trials being highly advantageous. Familiarity with FDA regulations is critical. Excellent communication skills are necessary for effective interaction with Principal Investigators and Sub-Investigators, as well as sponsor representatives. A deep understanding of clinical research processes and pharmacology is expected.
Key Responsibilities:
- Establish and enforce inventory management and drug accountability protocols for investigational medications at both the subject and study levels.
- Formulate and implement procedures to guarantee appropriate storage conditions for investigational medications.
- Design and execute processes for the preparation and dispensing of investigational study medications.
- Oversee the proper disposal of investigational medications upon study completion.
- Ensure secure storage of investigational medications within the pharmacy.
- Maintain access logs for authorized personnel in collaboration with the Medical Director/Principal Investigator.
- Contribute to the design and packaging of clinical drug supplies as requested by sponsors or the Medical Director/Principal Investigator.
- Provide insights into the clinical supplies section of study protocols as needed.
- Review and comply with sponsor requirements related to investigational medications for specific protocols.
- Assist in preparing protocols, informed consent documents, amendments, and other necessary materials for sponsor and IRB review.
- Support the Principal Investigator in administering informed consent to research participants.
- Maintain investigator/sponsor files in compliance with FDA and GCP guidelines.
- Engage in the recruitment and screening of research subjects to assess their eligibility for clinical studies.
- Develop and implement quality assurance and quality control procedures.
- Participate in sponsor or FDA audits as required.
- Gain comprehensive knowledge of study protocols and procedural flowcharts.
- Adhere to Standard Operating Procedures (SOPs) while coordinating studies and maintain personal training records.
- Perform study-related procedures such as venipunctures, specimen collection, and safety assessments as dictated by the study protocol.
- Document source data in collaboration with the Principal Investigator and Sub-Investigators.
- Ensure accuracy and completeness of study data and resolve any discrepancies in conjunction with the sponsor.
- Assist the Principal Investigator in collecting data for adverse event reporting.
- Collaborate with sponsors and senior management on subject recruitment and study progress updates.
- Support pharmacy inventory management and maintain records under the supervision of a licensed pharmacist.
- Follow established procedures for dispensing and storing investigational medications.
- Demonstrate independent judgment in addressing complex problems and developing evaluation criteria.
- Show initiative in enhancing knowledge and skills in clinical research.
- Participate in clinical meetings, both internal and external.
Equal Opportunity Employer: Frontage Laboratories Inc. is committed to providing equal employment opportunities to all qualified applicants without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, veteran status, or disability.
