Pharmacist

SRI Biosciences has an opening for a highly skilled and detail-oriented Pharmacist to support the Clinical Trials Unit in the execution of Phase I to Phase IV clinical trials. The Pharmacist will play a vital role in ensuring the safe and effective use of investigational products, maintaining regulatory compliance, and delivering high-quality pharmaceutical care in a research setting. This position requires collaboration with investigators, clinical staff, study participants, and external trial representatives (e.g. from Sponsors) to facilitate successful trial execution. This position is part time and located in our Plymouth, MI office.

Investigational Drug Management

Prepare and dispense investigational drugs and materials issued by Sponsor for ongoing research studies.
• Manage tasks such as: record-keeping, shipping of investigational products and associated items, ordering/inventory of supplies.
• Ensure the accuracy and integrity of investigational products prior to dispensing.
• Ensure compliance with all applicable regulations, including SRI International policies, FDA requirements, and sponsor guidelines for investigational or marketed drugs.
• Maintain pharmacy records to meet sponsor, regulatory, and legal requirements.
• Interpret and process orders for investigational drugs with precision and adherence to protocol guidelines.
• Accurately dispense medications and prepare products, as delineated by the Sponsor.
• Function as an unblinded study site personnel member when applicable.

Clinical Trial Support

• Oversee daily pharmacy operations related to study product management, including procurement, storage, inventory control, preparation, dispensing, accountability, labeling, handling, and final disposition of investigational products.
• Supervise temporary/hourly pharmacy personnel as applicable to ensure accuracy and adherence to regulatory and organizational standards.

Regulatory Compliance

• Maintain strict adherence to FDA, ICH-GCP, IRB, and other applicable regulations governing investigational drug use.
• Review and maintain study-related documentation, including pharmacy manuals, standard operating procedures (SOPs), and regulatory submissions.
• Assist with site inspections and audits, addressing findings related to investigational drug management.

Patient Safety & Care

• Ensure accurate dosing calculations, preparation, and dispensing of investigational products in compliance with protocol specifications.
• Provide counseling to study participants on investigational drug use, side effects, and potential risks, if applicable.
• Collaborate with the clinical team to monitor participants for adverse drug reactions and report findings appropriately.
• Document and report pharmaceutical protocol deviations as required.

Training & Collaboration

• Train clinical and pharmacy staff on investigational drug protocols, storage, and handling procedures.
• Participate in interdisciplinary meetings to provide pharmaceutical expertise and contribute to trial planning and execution.

Inventory Management

• Oversee the receipt, storage, labeling, and disposal of investigational products, ensuring adherence to study protocols.
• Conduct regular audits to verify inventory accuracy and compliance with study-specific guidelines.
• Manage inventory of emergency counter measure medications.

Education & Licensure

• Doctor of Pharmacy (PharmD) degree required; Master's degree or additional research-related certifications (e.g., BCOP, ACRP, SOCRA) preferred.
• Active pharmacist license in the state of Michigan.

Experience

• Minimum of 3 years of experience as a licensed pharmacist, preferably with exposure to clinical trials or investigational drug studies.
• Familiarity with Phase I-IV clinical trials, including early-stage (Phase I) pharmacokinetic and safety studies.

Skills & Competencies

• Strong understanding of investigational drug protocols, drug development processes, and clinical research regulations.
• Excellent organizational and documentation skills with keen attention to detail.
• Effective communication and interpersonal skills to collaborate with interdisciplinary teams.
• Ability to analyze complex protocols and provide clear guidance on drug-related matters.
• Proficiency in drug accountability systems.

Preferred Qualifications

• Experience in infectious diseases or vaccine trials.
• Knowledge of investigational drug shipping and storage logistics.
• Advanced training in pharmacology or clinical trial management.

Working Conditions

• May require occasional weekend or evening hours to meet trial timelines.
• Role involves standing, walking, and handling investigational drug products in a secure environment.

The salary range is: $64.45-$82.46/hr. Salary ranges will vary and are based on several factors, including geographic location, market competitiveness and equity amongst internal employees in similar roles. Positions may also qualify for SRI's Pay for Outstanding Performance program or the annual Performance Based Compensation program. SRI also has a competitive benefits package, to view details please go to https://www.sri.com/resources/benefits/. SRI will accept applications until the position is filled.

SRI is an independent nonprofit research institute headquartered in Menlo Park, Calif., with a rich history of supporting government and industry. We create and deliver world-changing solutions for a safer, healthier, and more sustainable future. For more than 75 years, we have collaborated across technical and scientific disciplines to discover and develop groundbreaking products and technologies and bring innovations and ideas to the marketplace.