About This RoleRevival Research Institute is seeking a
Contract Pharmacist with a minimum of one year of clinical experience to support clinical research study visits and investigational product (IP) preparation under appropriate oversight.
Prior clinical research experience is preferred but not required. This opportunity is ideal for a pharmacist interested in expanding their knowledge of clinical research while contributing to a growing organization with opportunities for professional development.
The ideal candidate is organized, detail-oriented, adaptable, and eager to learn. Strong communication skills, sound clinical judgment, and the ability to collaborate effectively with multidisciplinary teams are essential.
Responsibilities1. Review study requirementsReview the current protocol, pharmacy manual, preparation instructions, and sponsor-specific requirements.
Verify the prescribed dose, formulation, route of administration, and preparation method.
Confirm the participant's eligibility and required authorization before preparing the IP, according to site procedures.
2. Prepare and reconstitute the IPCalculate and verify the required dose, concentration, and volume.
Use the specified diluent, supplies, and preparation technique.
Follow required aseptic technique and applicable sterile-compounding standards when preparing injectable products.
Observe the specified preparation time, stability period, storage conditions, and beyond-use limits.
Maintain blinding and prevent cross-contamination or mix-ups between participants.
3. Perform quality checksVerify the product identity, dose, concentration, diluent, volume, and labeling.
Confirm the correct participant or study identifier.
Inspect the preparation for visible abnormalities, where applicable.
Perform an independent double-check when required by the protocol, pharmacy manual, or site SOP.
Resolve discrepancies before releasing the IP for administration.
4. Document IP preparationMaintain accurate, contemporaneous records, as applicable, including:
Participant or study identification.
IP name/code, batch or lot number, and expiration date.
Prescribed and prepared dose, concentration, and volume.
Diluent and quantities used.
Date and time of preparation.
Name or initials of the preparer and verifier, where required.
Final product labeling, storage, and release details.
5. Maintain IP accountability and storageMonitor and document storage temperatures according to sponsor requirements.
Maintain inventory, receipt, preparation, dispensing, and reconciliation records.
Quarantine affected product and promptly escalate temperature excursions or preparation errors.
Manage unused product, returns, and destruction according to sponsor authorization and applicable procedures.
These responsibilities align with the investigational product management principles in ICH E6(R3) and the FDA's clinical investigator regulations
Education & Training- Doctor of Pharmacy (PharmD) degree from an accredited college or school of pharmacy.
- Active, unrestricted pharmacist license in the state where services will be performed, with the ability to maintain licensure throughout the contract period.
Preferred Qualifications
- Minimum of one year of clinical pharmacy experience in a healthcare, hospital, outpatient, or comparable clinical setting.
- Prior clinical research experience is preferred but not required.
- Knowledge of medication preparation, dosage calculations, pharmaceutical safety, and proper medication handling procedures.
- Familiarity with Good Clinical Practice (GCP), FDA regulations, and investigational product management is preferred.
- Willingness to complete required study-specific training, including investigational product preparation, protocol requirements, and applicable regulatory procedures.
- Current knowledge of professional pharmacy standards, patient safety practices, and applicable state and federal regulations.
