As a Pharmacist, one will work under the direction of the Principal Investigator to execute clinical trials in adherence to FDA/ICH and other state and local regulations. Follows Good Clinical practice standards while conducting clinical research trials. Adheres to protocol requirements, protecting the rights and welfare of subjects
The JobEssential Functions- Ensure that adequate protocol training is given to ancillary staff to execute protocol.
- Complies with all protocol-specific guidelines for preparation, dispensing, and accounting for study medications.
- Ensures compliance with storage, maintenance, and temperature of study medications.
- Ensure GCP is followed throughout the entire study conduct.
- Train ancillary staff as necessary as directed by the Principal Investigator.
- Ensure subject safety in all instances.
- Available for on-call or on-site coverage including weekends and holidays as needed.
- Assist senior supervisor pharmacy in the day-to-day pharmacy operation.
Summary of Duties:- Executes clinical research trials in strict compliance of study protocol, standards of Good Clinical Practice, Standard operating procedures, QA/QC procedures, OSHA guidelines, Food and Drug Administration (FDA) guidelines and other state and local regulations where applicable.
- Effectively and professionally communicates with subjects, research teams, IRBs and sponsors.
- Meets regularly with the principal investigator and research teams to discuss subject participation and protocol progress.
- Receives adequate training on protocol and is able to train ancillary staff.
- Provides scientific review of protocols as well as editing or writing documents/manuals.
- Leads and supervises the Pharmaceutical staff. Manages and mentors personnel.
- Participate in monitoring visits and audits as needed.
- Participate in sponsor Investigator's meetings which may require travel off-site.
- Start-Up Procedures
- Has a working knowledge of GCP/ICH & FDA/DEA guidelines, Clinic SOPs and individual protocols.
- Possess a sound and in-depth understanding of each protocol that has been assigned.
- Attends study Initiation Meetings and Unit Protocol Training, as needed.
- Study Conduct
- Ensuring compliance with applicable MRA SOP's/MRA Clinical Research SOP's, Good Clinical Practice guidelines and regulations.
- Timely communication of study issues to the Senior Supervisor Pharmacy.
- Preparing, compounding and or dispensing study medications for distribution to unit staff.
- Serve as witness and quality check for double-blind studies.
- Assisting Senior Supervisor Pharmacy in the management of receipts, storage and disposition of all Investigational study medication.
- Assisting Senior Supervisor Pharmacy in control, accountability, receiving and shipping of investigational study medication and documentation.
- Ensuring all pharmacy related workspaces are cleaned, inspected and maintained and documented appropriately.
- Ensures compliance with storage, maintenance and temperature of study medications
- Preparing Dose Administration Records.
- Preparing Labels for dosing containers.
- Keep Study visit scheduling calendar.
- Study Documentation:
- Creating and maintaining the Pharmacy binder.
- Recording data collected onto source documents.
- Timely recordkeeping of completed study procedures in pharmacy logs as applicable.
- Filing essential study records & documents (i.e. subject records, regulatory documentation, etc.).
- Meeting with monitors and sponsor representatives.
- Preparing and initiating IP destruction procedures.
- Ensure all essential study records and documents have been filed correctly.
- Preparation of study records & documents for long-term storage.
- Retrieval of study records & documents from long-term storage.
Requirements- Working knowledge of GCPs.
- Excellent written and oral presentation skills.
- Ability to work well in a team environment.
- Ability to work a flexible schedule which requires overnight and weekend availability.
- Ability to foster open and ethical work environment.
- Knowledge of FDA/ICH guidelines.
- Adhere to Good Clinical practices.
- Must be bilingual - Spanish.
Why You Should Apply- Great learning opportunities, especially for those new to the field. Our seasoned professionals are here to support and work with you to explore your learning potential and career goals.
- Bonuses and merit increases are a part of the QPS total rewards approach and are linked to individual, team and company performance.
- Solid Benefits package, including Company-matched 401(k), and Company-sponsored Group Life/AD&D and Short and Long-term Disability Insurance
