Clinical Research Regulatory Specialist at Massachusetts General Hospital(MGH) in Boston, Massachusetts

Posted in Other 5 days ago.





Job Description:

Hiring Organization: The Providence VA Medical Center and VA RR&D Center for Neurorestoration and Neurotechnology (CfNN)


The Providence VA Medical Center and its VA RR&D Center for Neurorestoration and Neurotechnology (CfNN) seeks a new teammate with experience in clinical research, FDA and IRB interactions. The Center is a collaboration between Brown University, Butler Hospital, Lifespan, and Massachusetts General Hospital. CfNN develops, tests, and deploys novel neurotechnologies to improve the quality of life for Veterans with mobility impairments or mental health disorders. Our growing research portfolio includes internationally recognized human subjects research in brain-computer interfaces, neuromodulation for post-traumatic stress disorder, outcomes assessment and optimization studies in prosthetics for limb loss, and other injuries and illnesses of the nervous system. The Clinical Research Regulatory Specialist will coordinate and guide 28 physician and scientist investigators as well as lead a Core of clinical research assistants and coordinators, all focused on performing the most efficient and expert research to help Veterans and others by developing novel neurotechnologies and other device-related interventions to improve function.



Duties include but are not limited to:



  • Develop policies, procedures, and criteria for administration of CfNN's multiple projects;

  • Provide pre-reviews of new and evolving human subjects research protocols, working closely with study staff;

  • Select appropriate guidelines, determining which scientific and regulatory policies apply to CfNN's individual research endeavors;

  • Coordinate multi-site research reporting methods with our academic and hospital partners and collaborators;

  • Review project status reports to verify compliance with research reporting and administrative criteria;

  • Manage interactions between multiple Institutional Review Boards (IRBs) and Committees (both internal to VA and with the academic and hospital affiliates);

  • Train clinical research coordinators and other staff in best practices for efficient and effective human subjects research.

This role will be granted the opportunity to work from home at least one day per week but must be able to commute to the VA Providence Healthcare System and/or Brown University (Providence, RI) as needed. CfNN/VAPHS reserves the right to change this status with notice to employee.



Qualifications

Education and Experience:



  • Bachelor's or master's degree in biological or physical sciences or a related field

  • 5+ years relevant research regulatory experience in an academic, government, or industry environment

  • Knowledge of FDA, IRB, and GCP regulations


For more information:



Contact Kate Barnabe at kate.barnabe@va.gov



To Apply:



Please submit a resume and cover letter summarizing your interest and relevant skills/experience to Kate Barnabe at kate.barnabe@va.gov



EEO Statement

Massachusetts General Hospital is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. Applications from protected veterans and individuals with disabilities are strongly encouraged.
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