Clinical Trials Pharmacist (Part-Time) at Gertrude's Children's Hospital

• We are seeking a highly organized and knowledgeable Clinical Trials Pharmacist to support with the management of clinical trials. He/She will be involved in dispensing and monitoring of investigational drugs, ensuring compliance with protocols and regulatory requirements, and will work closely with research teams to provide expert pharmacological guidance throughout the trial process.

KEY RESPONSIBILITIES

• Clinical Trial Support:
• Review and interpret clinical trial protocols to understand medication-related aspects.
• Collaborate with investigators, clinical research associates, and study coordinators to ensure safe and proper use of investigational drugs.
• Assist in the preparation, dispensing, and storage of study medications.
• iv. Ensure the correct labelling, packaging, and distribution of investigational drugs as per the protocol.
• Regulatory Compliance:
• Maintain knowledge of applicable regulatory requirements from the Pharmacy and Poisons Board of Kenya and ICH-GCP and ensure compliance throughout the trial.
• Monitor the handling of investigational products to ensure adherence to clinical trial regulations and guidelines.
• Prepare and review documentation related to the clinical trial pharmacy, including consent forms, protocol amendments, and adverse event reporting.
• Safety and Reporting:
• Ensure that all adverse drug reactions (ADRs) and serious adverse events (SAEs) are reported promptly to the appropriate stakeholders.
• Assist in the preparation and review of safety reports for clinical trials.
• Participate in study monitoring visits and provide drug-related information to auditors and regulatory bodies as necessary.
• Training and Education:
• Provide training to study staff on investigational drugs and their safe handling.
• Stay current on pharmacological advancements and industry best practices in clinical trial management.
• Inventory and Documentation:
• Maintain accurate records of medication inventories, including the receipt, dispensing, and destruction of investigational products.
• Ensure proper documentation of all pharmaceutical activities related to clinical trials, ensuring compliance with Good Clinical Practice (GCP).

QUALIFICATIONS, EXPERIENCE AND SKILLS

• Education: Bachelor of Pharmacy degree from an accredited institution.
• Licensing: Valid pharmacist annual license from the Pharmacy and Poison’s Board of Kenya.
• Experience: Minimum of 1-2 years of experience in a clinical setting, with preference given to those with experience in clinical trials or research.

Skills:

• Strong knowledge of clinical pharmacology and investigational drug management.
• Familiarity with regulatory guidelines (FDA, ICH-GCP, etc.).
• Excellent organizational, communication, and problem-solving skills.
• Ability to work independently and as part of a multidisciplinary team.