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Clinical Research Regulatory Specialist

Full / Part Time: Full-Time
Location: Springfield, Massachusetts
Regular/Temporary: Regular

Baystate Health is seeking a Full-time Clinical Research Regulatory Specialist

What You Will Do:

As the Clinical Research Regulatory Specialist you will advise Investigators, Coordinators, and other staff re: IRB and Regulatory standards and responsibilities. Works in collaboration with IRB, SPA, and other BMC areas for study success, records and organizes data. Contributes to and maintains source documents and case report forms and compiles information for interpretation. Responsibilities may include meetings and collaboration with sponsor / CRO for study success.

Additional responsibilities will include:

  • Prepares submissions to the IRB, SPA, sponsors, contract research organizations, regulatory agencies, in collaboration with investigators and other research personnel in a skilled and timely manner.
  • Maintain electronic databases to track regulatory documents and submissions.
  • May Ship blood samples and specimens.
  • Maintenance of refrigeration / freezer logs, inventory / ordering of study supplies, scheduling of study appts, budget tracking, etc.
  • Assists with sponsor visits. May perform actual study tasks as appropriate in accordance with BMC policies and federal and state regulations.
  • Creates and maintains well organized and complete regulatory binders.
  • Contributes to and maintains study and patient files in a highly organized manner.
  • Maintains updated curriculum vitals and licenses for all investigators and research staff.
  • Contributes to ICF development.
  • Secures study and patient files to ensure confidentiality.

What You Will Need:

  • Education & Experience equivalent to Clinical Regulatory Coordinator (Non-RN)
  • Knowledge and skills necessary for this level are typically attained through 2-4 years of clinical research experience. Solid understanding of data collection and research principles.
  • Highly detail-oriented individual with excellent interpersonal and time management skills. Strong computer skills including database and web-based applications.
  • Specialty Certification in Clinical Research is preferred

Skills:

  • Strong knowledge of IRB requirements and Federal and State regulations as they relate to research.
  • Holds specialty certification in clinical research through an approved accrediting organization or college/graduate program. Records & Organizes Data.
  • Contributes to and maintains source documents and case report forms. Compiles information for interpretation.
  • Advises Investigators, Coordinators, and other staff re: IRB and Regulatory standards and responsibilities.
  • Works in collaboration with IRB, SPA, and other BMC areas for study success.
  • Responsibilities may include meetings and collaboration with sponsor/CRO for study success.

What You Need To Know:

Full-time / 40 hours

Location: Holyoke MA

Baystate Health is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, marital status, national origin, ancestry, age, genetic information, disability, or protected veteran status.

For a complete listing of all Baystate Health jobs, or to access an incomplete application, click here

Trouble applying or uploading a resume? We invite you to email us at talent.acquisitionFD@baystatehealth.org or call us at 413-794-3666.

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