Pharmacy Regulatory Technician, Research

Job Details

Job ID:

450 Brookline Ave, Boston, MA 02215


Employment Type:
Full time

Work Location:
Onsite: 100% onsite


The Pharmacy Regulatory Technician role will primarily be responsible for clinical trial audit support and the facilitation and licensing compliance of Dana-Farber physicians in associate with Title 105 CMR 700.009, a Massachusetts state law that requires a state-level license for all researchers conducting clinical research involving investigational drug products. 

This position’s work location is onsite, full-time on campus in Boston, MA.

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.


  • Practice as a pharmacy technician in accordance with federal, state, DFCI and Joint Commission policies, regulations, and standards.
  • Develop and maintain knowledge of the requirements for Massachusetts Controlled Substances Registration for Researchers.
  • Utilize Excel to analyze reports from multiple clinical trials information systems to identify physicians and associated investigational drug trials requiring state-based researcher licensure.
  • Obtain and maintain regulatory supporting documentation for licensure applications.
  • Monitor license application statuses and expirations, conduct follow-up and problem resolution to ensure timely initial applications and renewals.
  • Develop and maintain educational materials, communication templates and conduct training for physicians and disease centers.
  • Monitor and efficiently address support requests through the institutional email inbox for licensure support.
  • Provide on-going technical support for physicians applying and renewing licenses within the state’s digital eLicensing system though written, video conference and in-person solutions.
  • Coordinate with clinical trials leadership, the Massachusetts Department of Public Health, disease center leadership and pharmacy to complete licensing process, including any additional documentation, information, or applications.
  • Keep management informed of progress and escalate issues as needed related to licensure status.
  • Assist in the preparation and conduct of clinical trial audits involving the research pharmacy.
  • Provide coverage as needed for remote clinical trial monitor visits, the visits inbox and inventory management duties.
  • Prepare requested pharmacy documentation for clinical trial audits.
  • Communicate with Pharmacy staff and other DFCI staff involved in clinical trial audits.


  • Minimum Education:
    • High School or GED required; bachelor's degree preferred.
  • Minimum Experience:
    • 2 years of pharmacy technician experience. Experience with clinical research, regulatory policies or licensure preferred.
  • License/Certification/Registration:
    • Massachusetts Board of Pharmacy Registration as a Pharmacy Technician required within 6 months of employment. National Pharmacy Technician Certification (PTCB) must be obtained within 1 year of hire date.


  • Proficient use of the Microsoft Suite of Programs (Word, PowerPoint, Teams), Acrobat Pro, and Internet Resources (State websites and eLicensing systems).
  • Advanced use of Microsoft Excel for data analysis.
  • Experience with electronic profile systems used to track provider licensure and certificates details preferred.
  • Ability to adjust work time and schedule to meet daily demands in fast-paced environment.
  • Knowledge of inventory management control and Research Pharmacy systems.
  • Excellent interpersonal, oral and written communication skills.
  • Excellent organizational skills and attention to detail, including project management.
  • Ability to research and analyze data independently, utilizing strong critical thinking and problem-solving skills.
  • Strong customer service skills and the ability to interact professionally with peers, physicians, research leadership, and external contact.
  • Excellent organizational, time management, and analytical skills, with the ability to prioritize and manage multiple tasks/projects simultaneously and manage situations from start to finish.
  • Demonstrated flexibility and ability to change and set priorities, adapt to new situations and accept additional responsibilities based on the changing needs of the work setting.
  • Ability to prioritize, multitask and meet deadlines.
  • Ability to provide effective feedback.
  • Ability to work with diverse groups of people in an environment of frequently changing priorities and deadlines.
  • Ability to effectively work within a collaborative team-focused environment.

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 equally committed to diversifying our faculty and staff.  Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.

Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other groups as protected by law.

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