Regulatory Coordinator
Regulatory Coordinator
Posted on :
09-04-2025
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1 Vacancy
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Job Description
Massachusetts General Hospital is an Equal Opportunity Employer.By embracing diverse skills perspectives and ideas we choose to lead. Applications fromprotected veterans and individuals with disabilities are strongly encouraged.
Qualifications:
Ability to interact with interdisciplinary group including research scientists grants administrators clinical research staff and database team
Excellent understanding of ICH Guideline for Good Clinical Practice FDA OHRP DHHS regulations and guidelines
Excellent communication written and interpersonal skills.
Proficiency with Microsoft Office
Careful attention to detail and good organizational skills
Ability to work independently and as a team member.
Ability to work in fastpaced demanding clinical research environment in an effective and flexible manner.
Minimum degree and field of knowledge: BA/BS
Years experience required: 24 years clinical research experience including regulatory responsibilities
Summary:
The Ragon Institute of MGH MIT and Harvard was officially established in February 2009 and supported by the Phillip T. and Susan M. Ragon Foundation seeks to establish a model of scientific collaboration that links the clinical translational and basic science expertise at MGH MIT Harvard and the Broad Institute to tackle the greatest global health challenges related to infectious disease research. The Ragon Institute formerly known as Partners AIDS Research Center has a dual mission: to contribute to the accelerated discovery of an HIV/AIDS vaccine and subsequently to establish itself as a world leader in the collaborative study of immunology.
The Clinical Platform at the Ragon Institute is responsible for conducting the clinical research trials and maintenance of the Cellular Immunology Database. The Clinical Research Coordinator is an integral member of the clinical research team working in a fastpaced clinical research environment on multiple protocols.
The Regulatory Coordinator reports to the Regulatory Manager.
Job Duties:
Assist with development and writing of protocols informed consent documents recruitment tools data collection/case report forms
Maintenance of electronic and hard copy regulatory files
Participates in study team meetings
Assists investigators with Human Subject section of grant applications
Assists with Quality Assurance and Quality Control internal audits to monitor regulatory compliance of investigators and research staff
Acts as a liaison between the Partners Human Research Committee and Principal Investigators.
Processes CDC Permit applications and maintains central files for CDC permits
Facilitates obtaining Material Transfer Agreements Coded Tissue / Limited Data Use Agreements and maintains the central files (electronic and hard copy) for these agreements
Assists with other regulatory matters as needed
Required Experience:
IC
Employment Type
Full-Time
Key Skills
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