Clinical Trials Pharmacy Specialist
2 weeks ago
The Clinical Trials Pharmacy Specialist plays a crucial role in supporting clinical research initiatives by ensuring meticulous organization of documentation, executing pharmacy technician responsibilities, and maintaining effective communication with trial sites, coordinators, and participants while adhering to best clinical practices and established operational protocols.
ROLE AND RESPONSIBILITIES:In this position, you will be expected to:
- Oversee study operations to guarantee adherence to protocols and all applicable local, federal, and state regulations as well as institutional policies.
- Maintain comprehensive records of study activities, including case report forms, medication dispensation logs, and necessary regulatory documentation.
- Procure medications or devices essential for the successful completion of studies.
- Stay informed about developments in clinical research by reviewing scientific literature, engaging in continuing education, and attending relevant conferences.
- Prepare for and engage in quality assurance audits conducted by sponsors, regulatory bodies, or designated review committees.
- Organize storage for study-related equipment and supplies.
- Contribute to the formulation of study protocols, including guidelines for administration and data collection processes.
- Maintain communication with sponsors to coordinate site visits and address inquiries regarding data completeness.
- Identify issues within protocols, notify investigators, and assist in resolving problems, including protocol amendments.
- Dispense medications or devices, calculate dosages, and provide necessary instructions.
- Perform additional duties as assigned.
Reasonable accommodations may be provided to enable individuals with disabilities to fulfill the essential functions of this role.
JOB EXPECTATIONS:The successful candidate will:
- Comprehend, organize, and archive clinical trial documentation, including study protocols, standard operating procedures, resource documents, dispensing records, correspondence, training materials, and other relevant documents.
- Maintain up-to-date correspondence lists.
- Administer clinical trials in accordance with good clinical practices and standard operating procedures.
- Provide logistical support for clinical trials by processing subject and study site orders and coordinating the delivery of study medications and supplies.
- Be prepared for potential travel as required.
This overview outlines the general expectations for the position and should not be interpreted as an exhaustive list of responsibilities.
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