Oncology Clinical Trials Pharmacists assume responsibility and accountability for the safe, timely, and appropriate provision of investigational oncology agents. We offer dedicated research support, sharing the MGH mission to advance care through innovative research and education, and work in close collaboration with other members of the Mass General Brigham Cancer Institute and the Harvard Cancer Consortium. The Oncology Clinical Trials Pharmacist serves to protect the safety of study participants and the integrity of our clinical trials by ensuring compliance with institutional, sponsor and regulatory requirements surrounding investigational oncology medications and patient care.
• Review protocols and amendments for drug safety, feasibility, and impacts to clinicians and staff. Assist in the development of investigational chemotherapy Beacon treatment plans in EPIC
• Order review and verification of oncology clinical trials orders, including the review of protocol documents to ensure appropriateness based on current clinical, institutional, and protocol guidelines as well as patient-specific criteria
• Oversee the safe handling, preparation, and dispensing of investigational medications
• Ensure investigational medication orders comply with approved protocols
• Check admixtures for accurate preparation, including the additive(s), parent solution, and label
• Monitor investigational oncology treatment plans and study subjects’ place in therapy during the order review process and by following internal study instructions, and potential need for off-hours and weekend doses, ensuring supplies are available for infusion pharmacy staff
• Oversee oncology clinical trials Pharmacy technicians and students, serving as a resource for inventory management activities, and overseeing special projects
• Participate in the training and mentorship of new employees, students and residents
• Precepts learners (students, PGY1 Residents, PGY2 Residents). Meet Preceptor requirements as outlined in the MGH Residency Preceptor Responsibilities, Credentials, and Development Policy
• Promote a culture of safety; adhere to established practices and policies of the department
• Review study subject medications for appropriateness in collaboration with the study team. Review home medications for patients in screening for oncology clinical trials, identify prohibited medications and potential drug-drug interactions or additive toxicities
• Oversee technician activities and perform quality control checks
• Complete reports, including Safety Reports and Notes to File; develop corrective and preventative action plans
• Prepare and manage sponsor and FDA audits and monitoring visits