PHARMACIST

THIS IS A POOL POSITION WITH VARYING HOURS PER WEEK AND TIMES OF DAY.

Job Summary:

Essential Duties and Responsibilities:              

Dispensing and Compounding Investigational Products (IP):

• Prepare and dispense investigational drugs according to study protocols, Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP) guidelines when applicable.
• Compound or oversee the compounding of sterile and non-sterile IPs when required.
• Label IPs accurately, ensuring compliance with all regulatory and study-specific requirements.

Clinical Trial Support:

• Collaborate with research teams, including physicians, nurses, and coordinators, to ensure the correct administration of IPs.
• Review study protocols to identify and address potential issues related to drug handling, dosing, or administration.
• Participate in the setup, initiation, and close-out of clinical trials, ensuring pharmacy involvement in study design and implementation.

Regulatory Compliance and Documentation:

• Maintain up-to-date knowledge of FDA, ICH, and other relevant regulatory guidelines related to clinical trials and IP management.
• Ensure accurate and thorough documentation of IP dispensing, receipt, storage, returns, and destruction according to SOPs and regulatory requirements.
• Participate in internal and external audits, inspections, and monitoring visits.

Inventory Management:

• Manage IP inventory, including receiving, storing, and tracking of investigational drugs.
• Monitor drug storage conditions (e.g., temperature, humidity) and ensure compliance with sponsor and regulatory requirements.
• Assist in the coordination of drug shipments and returns to sponsors or contract research organizations (CROs).

Patient and Participant Safety:

• Review participant medical histories and drug interactions to ensure safe administration of investigational products, if applicable.
• Provide drug-related information and counsel to research staff and participants, addressing any concerns regarding IPs or concomitant medications.

Quality Control and Safety Measures:

• Monitor for and report adverse events or protocol deviations related to IPs, ensuring timely communication with study sponsors and regulatory authorities.

Additional Requirements

• Commitment to maintaining participant confidentiality and adhering to ethical standards in clinical research.
• Completion of all required CRO and regulatory training related to investigational products and clinical trials.
• Assist in the training of pharmacy students on their IPPE or APPE rotations.

Skills/Qualifications              

• Ability to read, write, and interpret the English language.
• Demonstrates strong analytical, problem-solving skills
• Strong written and verbal communication skills and ability to effectively communicate with Pharmaceutical Sponsors and Clients
• Self motivated, detail oriented, good organizational traits.
• Must be results oriented, multi-tasking, quick learner, respond to the urgent needs of the team and show a strong track record of meeting deadlines.
• Exceptional computer skills, including advanced knowledge of Microsoft Office Suite; inclination to adopt technology to maximize efficiency

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Ability to sit, stand, walk, reach with hands and arms, and use hands along with fingers, to handle or feel.
• Ability to lift and/or move up to 25 pounds.
• Specific vision abilities required by this job include clarity of vision both near and far. 
• Ability to identify and distinguish colors.
• Must be able to work in a controlled, regulated environment, including cleanrooms and sterile preparation areas.
• Requires occasional standing, lifting, and handling of pharmaceutical supplies.
• Availability to work flexible hours, including weekends and holidays, depending on clinical trial demands.

Hazards:

• Potential for exposure to toxic or caustic chemicals
• Potential for exposure to blood borne pathogens
• Potential for exposure to radioactive materials

Education and Experience:

• Registered Pharmacist with preferably a minimum three years of hospital or industry-sponsored clinical trials experience. Advanced degree preferred.
• Valid Wisconsin Pharmacist License
• Required broad knowledge of clinical research and drug development
• Success in independent clinical project management preferred
• Specific and in-depth knowledge of ICH GCP and 21 CFR

 Spaulding Clinical Research management has the discretion to hire personnel with a combination of experience and education which may vary from the above listed skills and qualifications.