PRIM&R accepts advertisements from all institutions seeking to hire for positions in animal and human research ethics and related fields, such as research administration and ethics education; listing does not imply endorsement of the lister or of the qualifications stated for a position.
Assists in supporting the day-to-day Regulatory Compliance functions for existing and new human subject protocols for the Ragon Institute. This includes preparing the required regulatory submissions, such as initial and continuing reviews/expedited check-ins, amendments, adverse events, protocol deviations/violations and other reportable events as required by the MGB IRB utilizing the Insight system. Maintains protocol documentation and tracking of human subject research submissions and deadlines.
PRINCIPAL DUTIES AND RESPONSIBILITIES
• Supports the management of IRB submissions, includes preparation and submission of protocol applications. This may also include assisting with protocol development, consent writing and preparation of recruitment and other study materials as required. • Track and store electronically all related IRB documents associated with Initial and Continuing Review/Expedited Check-in submissions, as well amendments, notifications, approval letters and other similar materials. • Initiate, coordinate, and lead meetings with Principal Investigators, Project Managers and research scientists as needed. • Assists investigators with Human Subject section of grant applications • Actively participates with other members of the Ragon Institute Administrative and operations team in meetings and projects. • Assists with Quality Assurance and Quality Control internal audits to monitor regulatory compliance of investigators and research staff • Strategizes ways to develop improved processes and efficiencies in response to changing regulatory requirements. • Other Responsibilities—perform other duties as assigned by Regulatory Compliance Program Director
One to two years prior work experience in professional administrative support or project management required, preferably in an academic or research environment. Bachelor’s degree required. • Previous experience with Institutional Review Board (IRB) communications, to include coordination of IRB submissions. • Experience in managing compliance with Investigators and other research staff. • Must be highly organized and pay strong attention to detail and accuracy; be self-motivated and assertive. • Ability to work independently and as a team member, in fast-paced, demanding, clinical research environment in an effective and flexible manner. • Must have excellent written and verbal communication skills. • Proficiency with Microsoft Office
Internal Number: 3155165
About The Ragon Institute of MGH, MIT and Harvard
The Ragon Institute of MGH, MIT and Harvard was officially established in February 2009 with a $100 million donation from the Philip T. and Susan M. Ragon Foundation. Our mission is to harness the immune system to prevent and cure human disease.
Our Institute works in six research priority areas: HIV/AIDS, Global Infectious Diseases, Emerging Infectious Diseases, Vaccine Development, Basic and Applied Immunology, and Clinical studies. Each research area contributes to our goal of understanding the immune system in order to prevent and cure disease.
Our faculty and collaborators bring expertise from areas such as innate and adaptive immunology, virology, biochemistry, structural biology, physics, engineering, computational biology, vaccinology, as well as physician scientists conducting translational clinical studies of candidate vaccines and immunotherapy. The Ragon Institute brings people together with the understanding that progress comes not from silos of expertise, but from a vibrant, collaborative community with knowledge building as it flows from field to field, each approach and perspective giving valuable insights to solve global medical problems