University of Massachusetts Medical School

Regulatory Spec

US-MA-Worcester
3 weeks ago
Requisition Number
2017-29701
# of Openings
1
Shift
Day
Exempt/Non-Exempt Status
Exempt

Overview

GENERAL SUMMARY OF POSITION:

Under the direction of the Director or designee, the Regulatory Specialist will facilitate clinical trial implementation and ensure regulatory compliance for the conduct of clinical research at UMMS/UMMHC.

Responsibilities

MAJOR RESPONSIBILITIES:

  • Prepare initial Institutional Review Board (IRB) research applications for UMMS and UMMHC investigators to appropriate IRB systems such as eIRB, WIRB, CIRB

  • Prepare any subsequent submissions such as modifications, Reportable New Information (RNI), continuing reviews, study closures

  • Consult with study team with regard to the response to the IRB concerns

  • Submit the required regulatory documents to sponsors such as 1572s, financial disclosure forms (FDFs)

  • Prepare and maintain regulatory documents and binders for UMMS and UMMHC investigators

  • Maintain department “shared drive” in regards to regulatory files

  • Participate in internal quality assurance audits of research activities involving human subjects at UMMS and UMMHC

  • Provide guidance to investigators and coordinators regarding Good Clinical Practices (GCPs) in research involving human subjects

  • Provide guidance and assistance to investigators in preparing Investigational New Drug applications (INDs) and Investigational Device Exemptions (IDEs) to the Food & Drug Administration (FDA)

  • Act as liaison between investigator, sponsor and FDA personnel

  • Perform other duties as required.

Qualifications

REQUIRED QUALIFICATIONS:

  • Bachelor’s degree in biological science, health care, or equivalent experience
  • 5 years experience in research and/or administration
  • Demonstrated familiarity with research protocols, regulatory mandates, and staff education   
  • Demonstrated oral and written communication skills necessary to interact with investigators, study staff, research administrators and auditors
  • Ability to travel to off-site location

 

PREFERRED QUALIFICATIONS:

  • Preferred certifications: CIP, CCRC

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