Massachusetts General Physicians’ Organization
Clinical Trials Pharmacist
Massachusetts General Physicians’ Organization, Boston, Massachusetts, us, 02298
Job Description - Clinical Trials Pharmacist (3301255)Clinical Trials Pharmacist - (3301255)
As an integral member of the pharmacy team, the Clinical Trials Pharmacist is responsible for coordinating, collaborating, and providing expertise in support of drug clinical trials. The Pharmacist will review protocol documents, draft instructions, dispense investigational medication, provide supervision, perform educational activities, communicate with the sponsor and study staff, participate in patient care, maintain overall responsibility for pharmacy operations in the assigned area and perform other duties consistent with the job classification and as required.
PRINCIPAL DUTIES AND RESPONSIBILITIES:Review new protocols and amendments for drug safety and feasibility.Reviews protocol documents and drafts dispense instructions.Acts as a liaison for principal investigators, the research office, sponsors, pharmacy, and the Institutional Review Board (IRB).Ensures medication orders comply with approved protocols.Dispenses research medication to subjects enrolled in clinical trials.Reviews patient medications for appropriateness.Reviews patients’ medication regimens for drug interactions. Addresses issues with study team.Triages and participates in sponsor monitoring visits and audits.Manages investigational drug inventory for studies. Coordinates drug receipt, destruction and returns per protocol.Oversees the safe handling and preparation of investigational medications.Provides drug information to other health care professionals.Reviews new drug protocols as IRB ancillary reviewer.Promotes a culture of safety; adheres to established practices and policies of the department and notifies the manager of deviations in standard practices.Participate in the training and mentorship of new employees, students and residents.Acts as a liaison between CTP and compounding, as well as other areas within the department of pharmacy.Assists with special projects assigned by the manager.Assures that adequate communication is maintained between staff for continuity of service.Participates in and identifies quality improvement projects.Oversees technician activities and performs quality control checks.Attends and participates in Institutional Review Board (IRB) meetings.Completes reports including Safety Reports and Notes to File.Complies with state and federal laws pertinent to pharmacy and investigational drug use.
REQUIRED:Massachusetts Pharmacist License in good standingHospital Pharmacy Experience
PREFERRED:Research pharmacy experienceNon-sterile and Sterile compounding experienceHuman Subject Research Protection (HSRP) certificationGood Clinical Practice (GCP) certification
SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:Excellent verbal and written communication skillsProficient computer related skills, including Microsoft Office (Word, Excel, PowerPoint, Access)Fluency in EnglishExcellent interpersonal and communication skillsAbility to recognize emergency situations and respond appropriatelyExcellent comprehension of written policies and proceduresAbility to make appropriate decisions, develop and complete follow-up actionsAttention to detail and organizational abilityAbility to work well on a team as well as independentlyAbility to plan, organize and prioritizeAbility to motivate and develop othersGeneral understanding of compounding testing requirementsAbility to meet deadlinesCompetent in math skills, including proportions, ratios and conversionsExcellent telephone skillsMonitors and assures security of narcotics and controlled substances in accordance with hospital policy, as well as Federal and State Law
WORKING CONDITIONS:Must be able to lift to 20 lbs.Must be able to stand or sit for extended periods of time.
Massachusetts General Hospital is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law.
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As an integral member of the pharmacy team, the Clinical Trials Pharmacist is responsible for coordinating, collaborating, and providing expertise in support of drug clinical trials. The Pharmacist will review protocol documents, draft instructions, dispense investigational medication, provide supervision, perform educational activities, communicate with the sponsor and study staff, participate in patient care, maintain overall responsibility for pharmacy operations in the assigned area and perform other duties consistent with the job classification and as required.
PRINCIPAL DUTIES AND RESPONSIBILITIES:Review new protocols and amendments for drug safety and feasibility.Reviews protocol documents and drafts dispense instructions.Acts as a liaison for principal investigators, the research office, sponsors, pharmacy, and the Institutional Review Board (IRB).Ensures medication orders comply with approved protocols.Dispenses research medication to subjects enrolled in clinical trials.Reviews patient medications for appropriateness.Reviews patients’ medication regimens for drug interactions. Addresses issues with study team.Triages and participates in sponsor monitoring visits and audits.Manages investigational drug inventory for studies. Coordinates drug receipt, destruction and returns per protocol.Oversees the safe handling and preparation of investigational medications.Provides drug information to other health care professionals.Reviews new drug protocols as IRB ancillary reviewer.Promotes a culture of safety; adheres to established practices and policies of the department and notifies the manager of deviations in standard practices.Participate in the training and mentorship of new employees, students and residents.Acts as a liaison between CTP and compounding, as well as other areas within the department of pharmacy.Assists with special projects assigned by the manager.Assures that adequate communication is maintained between staff for continuity of service.Participates in and identifies quality improvement projects.Oversees technician activities and performs quality control checks.Attends and participates in Institutional Review Board (IRB) meetings.Completes reports including Safety Reports and Notes to File.Complies with state and federal laws pertinent to pharmacy and investigational drug use.
REQUIRED:Massachusetts Pharmacist License in good standingHospital Pharmacy Experience
PREFERRED:Research pharmacy experienceNon-sterile and Sterile compounding experienceHuman Subject Research Protection (HSRP) certificationGood Clinical Practice (GCP) certification
SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:Excellent verbal and written communication skillsProficient computer related skills, including Microsoft Office (Word, Excel, PowerPoint, Access)Fluency in EnglishExcellent interpersonal and communication skillsAbility to recognize emergency situations and respond appropriatelyExcellent comprehension of written policies and proceduresAbility to make appropriate decisions, develop and complete follow-up actionsAttention to detail and organizational abilityAbility to work well on a team as well as independentlyAbility to plan, organize and prioritizeAbility to motivate and develop othersGeneral understanding of compounding testing requirementsAbility to meet deadlinesCompetent in math skills, including proportions, ratios and conversionsExcellent telephone skillsMonitors and assures security of narcotics and controlled substances in accordance with hospital policy, as well as Federal and State Law
WORKING CONDITIONS:Must be able to lift to 20 lbs.Must be able to stand or sit for extended periods of time.
Massachusetts General Hospital is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law.
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