Regulatory Pharmacist Specialist, Research Pharmacy

The Pharmacist, Research Specialist supports patient care by understanding the clinical trial research protocol, providing clinical trial education to the pharmacy staff, coordinating study drug inventory/supplies, and assisting sites with any operational and regulatory concerns related to the clinical trial.

Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS, and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations.

We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.

Primary Duties and Responsibilities:

• Practice as a pharmacist in accordance with all federal, state, DFCI, DF/HCC, and Joint Commission policies, regulations, and standards and serves as the primary pharmacist on the delegation logs and maintains their NCI, CITI, and GCP trainings.
• Oversee site readiness of new clinical trials and follow the progress of clinical research protocols along with the study team for safety, efficacy, appropriateness of drug and dose, and/or operational concerns.
• Work with site pharmacy and Main Campus - Longwood regarding investigational drug supply/inventory, and drug ordering as well as troubleshoot active patient issues.
• Monitor site based investigational drug inventory management and investigational drug accountability (e.g., drug procurement, expiration date updates, cycle counts, drug destruction, receipt verification of investigational products, compounding records, etc.) for new and existing patients.
• Collaborate with other members of the pharmacy, multidisciplinary clinical teams, study teams, and other departments internal and external to the Institute, communicate logistics and provide education/training on clinical trial details and operational considerations involved with the clinical research program.
• Ensure that investigational products are being prepared according to the established protocol and in consideration of patient and protocol parameters from the review and set-up of the trial to the patient dispense.
• Participate in audits (e.g., preparation activities, NCI, sponsor quality assurance, FDA, etc.).
• Participate in EPIC Beacon research treatment plan order and Willow medication build review.
• Attend research meetings that have clinical trials at the satellite sites to gain an understanding of priorities and upcoming patient treatments
• Participate in new clinical trial review as well as amendment review with a focus on satellite site operations.
• Other duties and projects as assigned.

Knowledge, Skills and Abilities:

• Ability to critically assess clinical trial documents, references and/or drug information sources with attention to detail.
• Works effectively as a member of a unit team, cross functional teams and thrives in team-oriented environments.
• Prioritizes and adapts to change; accepts additional responsibilities based on the changing needs of the work setting.
• Ability to effectively work and communicate with other pharmacy team members, patients, providers, and other institutions.
• Proficient in the use of all technology, references, workflows, safety reporting and protocol documentation required to perform primary job functions.
• Ability to plan, organize, prioritize, work independently to meet deadlines, and adapt to changes in high-volume situations; accepts additional responsibilities based on the changing needs of the work setting.
• Participate in training and orienting new satellite pharmacists.

Minimum Job Qualifications:

All Pharmacists require a Bachelor of Science in Pharmacy or Doctor of Pharmacy degree from an accredited college of Pharmacy.  5 years of hospital pharmacy or pharmaceutical industry experience with at least 2 year of oncology, regulatory, or clinical research experience required.

License/Certification/Registration Required:

Must be licensed to practice pharmacy in the Commonwealth of Massachusetts.

Supervisory Responsibilities:

No

Patient Contact:

No

Special Working Conditions:

Routine, direct exposure to chemotherapeutic agents, biologic agents, investigational agents, gene therapy, potentially dangerous and flammable chemicals.  Potential for sticks or cuts by needles and other sharp items.  Potential for exposure to infectious patients and/or materials.

At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are committed to having faculty and staff who offer multifaceted experiences. Cancer knows no boundaries and when it comes to hiring the most dedicated and compassionate professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.

EEO Poster

. Pay Transparency Statement

The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate’s relevant experience, skills and qualifications.

For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA).

$158,200.00 - $170,000.00