Senior Regulatory Specialist
Partners HealthCare, Human Research Quality Improvement (QI) Program
Deadline: March 04, 2016
The goal of the Partners Human Research Quality Improvement (QI) Program is to help fulfill the institution's responsibility for ensuring compliance with federal and state regulations governing human research, and to promote an environment in which human subject research will be conducted according to the highest standards. In doing so, the QI Program is committed to providing on-going support and education to the research community. QI staff work closely with study investigators and research staff to ensure optimal conduct of human research within the framework of federal regulations, institutional policies, and good clinical practice.
In conjunction with the Assistant Director, the Senior Regulatory Specialist is responsible for developing and implementing QI Program activities that support FDA regulated trials, including Sponsor-Investigators (IND/IDE holder), and requirements for clinical trials registration and disclosure. The goal of the activities is to ensure the Investigator and Institution remain in compliance with federal, state and local requirements. Incumbent is required to have excellent working knowledge of regulations, policies and local requirements in these areas and be able to apply knowledge directly when working with specific Investigators and/or study teams. This position will play a critical role in supporting Investigators with ClinicalTrials.gov basic results data entry. Scope of work includes research communities of Massachusetts General Hospital, Brigham and Women’s Hospital, McLean, North Shore Medical Center, and Spaulding Rehabilitation Hospital. Reports to Assistant Director, FDA Sponsor-Investigator Support and Clinical Trials Registration.
Principal Duties and Responsibilities:
Clinical Trials Registration and Disclosure Responsibilities:
- Participates in all day-to-day activities associated with clinical trials registration and disclosure, including:
- Expert guidance on interpretation for clinical trials registration requirements including FDAAA, ICMJE, CMS, and NIH;
- Guidance and support to research community regarding ClinicalTrials.gov database;
- Set-up of ClinicalTrials.gov accounts;
- Compliance with registration and results disclosure requirements, and escalation to applicable Research Compliance and/or Institutional Officials;
- Education programs and information on Research Navigator website related to Clinical Trials Transparency.
- As assigned, provides one-on-one assistance to investigator initiated trials requiring results data entry;
- With Assistant Director, develops system to prospectively identify and track studies with required results reporting;
- Participates in National Clinical Trials Registration Taskforce – a monthly meeting of clinical trial registration experts at Academic Medical Centers (AMC) focusing on clinical trials registration and results reporting issues that affect US AMCs.
FDA Regulated Research Responsibilities:
- Participates in development and implementation of all activities related to Partners FDA IND/IDE Sponsor-Investigators, including:
- Mandated Sponsor-Investigator Responsibility audit program;
- IRB-mandated IND/IDE Sponsor-Investigator education and training prior to study activation;
- Sponsor-Investigator IND/IDE Applications to FDA, IND/IDE New Protocol or New Investigator Protocol Amendments and Annual Reports;
- Education programs and information on Research Navigator website related to FDA IND/IDE Sponsor-Investigators.
- Assists onsite FDA investigator inspection preparation activities;
- Participates in development and implementation of strategies to ensure Partners investigators conduct FDA regulated research in accordance with all applicable federal and state regulations;
- Maintains content of information on website dedicated to regulatory information applicable for Sponsor-Investigators and Clinical Trials Registration;
- Develops checklists and other tools to assist investigators and research staff.
- General Responsibilities:
- Conducts QI audits (for-cause and not-for-cause) as needed;
- Provides QA/QI education as needed;
- Facilitates and implement ongoing quality improvement projects as assigned.
- Uses the Partners HealthCare values to govern decisions, actions and behaviors. These values guide how we get our work done: Patients, Affordability, Accountability & Service Commitment, Decisiveness, Innovation & Thoughtful Risk; and how we treat each other: Diversity & Inclusion, Integrity & Respect, Learning, Continuous Improvement & Personal Growth, Teamwork & Collaboration;
- Other duties as assigned.
BS required; Master’s degree in related field preferred (epidemiology, biostatistics, pharmacology, biochemistry, etc.); or, equivalent combination of experience and education;
- 3 years experience in human subjects’ research. This can include: research management experience, clinical trials experience, Industry experience, or IRB experience;
- 1 year experience with analysis and reporting of clinical trial data;
- 1 year experience with standard mathematical concepts and statistics;
- 1 year experience in drug or device regulatory environment including expertise in FDA applications and interaction with FDA;
- Demonstrated knowledge of federal and state regulations governing clinical research, and GCP guidelines.
- Ability to read and comprehend technical documents and data;
- Desire to work both independently and within team unit.
- Excellent verbal and written communication skills;
- Excellent interpersonal and organizational skills.