Current jobs related to Assistant Director of Research Compliance, Quality Improvement Program - Cambridge, Massachusetts - Harvard University
-
Director of Research and Engineering
2 days ago
Cambridge, Massachusetts, United States MIT Full time**Job Summary**MIT is seeking a highly experienced and skilled professional to serve as the Associate Director of the Bates Research and Engineering Center. This is a leadership role that requires a strong background in nuclear science and engineering, as well as excellent management and communication skills.**Key Responsibilities**Oversee the management of...
-
Cambridge, Massachusetts, United States Bicycle Therapeutics Full timeCompany OverviewBicycle Therapeutics is a pioneering biopharmaceutical organization focused on developing a unique class of therapeutic agents known as Bicycle molecules. These fully synthetic short peptides are designed with small molecule scaffolds, creating two loops that enhance their structural stability. This innovative design allows for high-affinity...
-
Assistant Director of Operations, Vivarium
3 weeks ago
Cambridge, Massachusetts, United States Massachusetts General Hospital(MGH) Full timeGENERAL SUMMARY/OVERVIEW STATEMENT:The Ragon Institute is a highly unique, innovative, and collaborative research center at the forefront of biomedical science. Founded by Massachusetts General Hospital, MIT, and Harvard, the Ragon vision is a bold one: to harness the power of the immune system to prevent and cure human disease on a global scale. This vision...
-
Cambridge, Massachusetts, United States Bicycle Therapeutics Full timeCompany OverviewBicycle Therapeutics is a pioneering biopharmaceutical organization focused on developing innovative therapies, known as Bicycle molecules, aimed at addressing unmet medical needs. These fully synthetic peptides, constrained by small molecule scaffolds, exhibit high affinity and selectivity for their targets, making them promising candidates...
-
Cambridge, Massachusetts, United States Bicycle Therapeutics Full timeCompany OverviewBicycle Therapeutics is a pioneering biopharmaceutical organization focused on developing innovative therapies known as Bicycle molecules. These fully synthetic peptides are designed to address medical conditions that lack effective treatments. Our research includes advanced candidates such as BT8009, BT5528, and BT7480, all undergoing...
-
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe Role:Moderna is seeking a Director, PV Operations Compliance, Alliance, and Process Excellence responsible for ensuring the highest level of complianceas part of Modernas Pharmacovigilance Quality Management System by providing oversight of commercial programs, establishing a framework for affiliate PV standards, and managing business continuity. This...
-
Quality Compliance Analyst
5 days ago
Cambridge, Massachusetts, United States Philips Full timeJob Title Supplier Quality Analyst Job Overview In this role, you will be responsible for formulating and executing our Supplier Quality (SQ) strategy, ensuring that business requirements are effectively translated into supplier quality solutions while maintaining adherence to regulatory standards and protocols for regulated products and processes. ...
-
Educational Research Scientist
1 week ago
Cambridge, Massachusetts, United States Society for Learning Analytics Research Full timePosition Overview:The Society for Learning Analytics Research is seeking a dedicated Educational Research Scientist to join our innovative team. This role focuses on exploring effective learning methodologies and enhancing educational experiences through technology integration.Key Responsibilities:As a vital member of our collaborative research team, you...
-
Cambridge, Massachusetts, United States Bicycle Therapeutics Full timeCompany OverviewBicycle Therapeutics is a pioneering biopharmaceutical organization focused on creating innovative therapies known as Bicycle molecules. These fully synthetic peptides are designed to address unmet medical needs in various diseases. Our leading candidates include BT8009, BT5528, and BT7480, all undergoing rigorous clinical trials. We are also...
-
Director of Quality Assurance Operations
5 days ago
Cambridge, Massachusetts, United States Alkeus Pharmaceuticals, Inc. Full timeAbout Alkeus PharmaceuticalsAlkeus Pharmaceuticals, Inc. is a biopharmaceutical organization focused on developing innovative therapies for serious eye diseases that can result in vision loss. Our primary investigational compound, gildeuretinol (ALK-001), is an oral medication aimed at treating Stargardt disease (STGD) and Geographic Atrophy (GA) linked to...
-
Director of Quality Assurance Operations
5 days ago
Cambridge, Massachusetts, United States Alkeus Pharmaceuticals, Inc. Full timeAbout Alkeus PharmaceuticalsAlkeus Pharmaceuticals, Inc. is a pioneering biopharmaceutical organization focused on developing innovative therapies for serious eye diseases that can lead to vision loss. Our primary investigational compound, gildeuretinol (ALK-001), is an oral medication being explored for the treatment of Stargardt disease (STGD) and...
-
Director of Quality Assurance Operations
7 days ago
Cambridge, Massachusetts, United States Alkeus Pharmaceuticals, Inc. Full timeAbout Alkeus PharmaceuticalsAlkeus Pharmaceuticals, Inc. is a pioneering biopharmaceutical organization focused on developing groundbreaking therapies to combat severe, progressive ocular diseases that can result in vision loss. Our primary investigational compound, gildeuretinol (ALK-001), is an oral medication under development for treating Stargardt...
-
Cambridge, Massachusetts, United States Alkeus Pharmaceuticals, Inc. Full timeAbout Alkeus PharmaceuticalsAlkeus Pharmaceuticals, Inc. is a pioneering biopharmaceutical firm focused on developing groundbreaking therapies for serious eye diseases that can lead to vision loss. Our flagship compound, gildeuretinol (ALK-001), is an oral investigational medication aimed at treating Stargardt disease (STGD) and Geographic Atrophy (GA)...
-
Cambridge, Massachusetts, United States Bicycle Therapeutics Full timeCompany OverviewBicycle Therapeutics is a pioneering biopharmaceutical organization focused on developing innovative medicines, known as Bicycle molecules, for conditions that lack effective treatments. These fully synthetic short peptides are designed with small molecule scaffolds, creating a unique structure that enhances their ability to bind to targets...
-
Cambridge, Massachusetts, United States Alkeus Pharmaceuticals, Inc. Full timeAbout Alkeus PharmaceuticalsAlkeus Pharmaceuticals, Inc. is a late-stage biopharmaceutical organization focused on developing groundbreaking therapies for serious, progressive ocular diseases that can result in vision loss. Our primary investigational compound, gildeuretinol (ALK-001), is an oral medication under development for treating Stargardt disease...
-
Senior Accounting and Compliance Specialist
2 days ago
Cambridge, Massachusetts, United States Broad Institute Full timeThe Broad Institute is at a pivotal moment in its evolution, poised to shape the next chapter of its growth and impact.We are seeking a seasoned Controller to join our team, responsible for overseeing a wide range of sophisticated accounting, compliance, and audit functions across multiple entities.As a key member of our finance team, you will demonstrate...
-
Cambridge, Massachusetts, United States Alkeus Pharmaceuticals, Inc. Full timeAbout Alkeus PharmaceuticalsAlkeus Pharmaceuticals, Inc. is a late-stage biopharmaceutical organization dedicated to developing groundbreaking therapies aimed at treating severe, progressive ocular diseases that can result in vision loss. Our primary investigational compound, gildeuretinol (ALK-001), is an oral medication currently being explored for its...
-
Clinical Research Scientist
1 week ago
Cambridge, Massachusetts, United States Integrated Resources, Inc Full timePosition OverviewJob Title: Clinical Research ScientistLocation: Remote/OnsiteDuration: Long-term ContractShift: Day ShiftKey Responsibilities:Contribute to the Systemic Mastocytosis portfolio and the BLU 808 clinical trial.Collaborate with Medical Directors, Pharmacology teams, Discovery departments, external specialists, and research investigators to...
-
Academic Researcher
2 days ago
Cambridge, Massachusetts, United States Massachusetts Institute of Technology Full timeJob SummaryWe are seeking a highly qualified Academic Researcher to join our team at the Massachusetts Institute of Technology. The successful candidate will be responsible for teaching graduate-level courses and conducting research in the area of technology and urban planning.Key ResponsibilitiesDevelop and teach two graduate-level classes per year on...
-
Quality Assurance Compliance Analyst
1 week ago
Cambridge, Massachusetts, United States Accuro Full timePosition: Quality Assurance Compliance Specialist (QUMAS, MyCIMS)Role Overview: This position involves the management and oversight of quality assurance compliance processes, utilizing tools such as QUMAS and MyCIMS.Location: Cambridge, MAContract Duration: 12+ MonthsKey Responsibilities:Implement and maintain data quality management (DQM) practices.Ensure...
Assistant Director of Research Compliance, Quality Improvement Program
2 months ago
Assistant Director of Research Compliance, Quality Improvement Program
Harvard Business School
65858BR
Job Summary
The Assistant Director is a member of a cross-functional team supporting a wide range of research programs and activities for the Harvard Business School (HBS) faculty and its governance. In partnership with the Director of Research Compliance, the Assistant Director has primary responsibility for developing and implementing the Quality Improvement Program (QIP) at HBS, a Program that will provide a variety of human research and regulated data support and education to the HBS research community, and will work closely with the Compliance Team to advise investigators throughout the IRB process.
Additionally, as part of the Research Compliance team, the Assistant Director will provide services and training to the HBS research community, and work to ensure compliance with federal, state and local research regulations, as well as HBS and Harvard University policies and procedures related to regulated research. The Assistant Director will also partner with HBS research community stakeholders and the Assistant Director of Research Compliance, Data Management, to help establish a coherent and comprehensive set of processes, procedures, and guidance around proper research data management practices.
Position Description
Reporting to the Director of Research Compliance, and working closely with the Assistant Director of Research Administration and Human Subjects Protection, and other members of the Research Compliance and Research Administration teams, the Assistant Director will focus on supporting the research and scholarly activities of the HBS faculty by building and operationalizing a comprehensive Quality Improvement Program and associated guidance and training. S/he will assist faculty and staff with research study support requests, IRB submission assistance and review, study start-up and close-out consultation, and ensure the ethical principles that apply to research projects are reflected in study documentation and adhered to. The Assistant Director will also support the Research Compliance team's operations and support special projects as needed.
The Assistant Director's principal duties and responsibilities include:
Quality Improvement Program (QIP) oversight:
Creating and implementing short- and long-term objectives for QIP, including but not limited to documenting intake parameters and processes, standardizing expectations for required reviews, trainings and approvals, and strategizing engagement with other HBS and University stakeholders who are involved in research procedures.
Developing and delivering educational curriculum specific to the HBS research community by request and when initiated by the HBS Research Compliance team, including providing guidance to researchers and administrators on processes and requirements related to human subjects research and the research lifecycle.
Providing front-line support and information for researchers and staff, including HBS faculty, students, staff, and other research team members. This may include consulting on effective study design, recommendations for best practices for the maintenance of study sites, and on-site monitoring to ensure appropriate implementation.
Working closely with the Assistant Director of Research Administration and Human Subjects Protection, as well as with Harvard University's Committee on the Use of Human Subjects (CUHS) and Longwood Medical Area QIP to ensure policies and procedures are consistently applied at HBS.
Drafting reports (including analysis of compliance records), study management tools, and other QIP materials.
Developing a strategy for the dissemination of QIP materials, including the Research Compliance newsletter and associated web content
Supporting Compliance team processes and procedures to help aid regulatory compliance, including protocol adherence, accurate record keeping, onboarding, and use of appropriate tools and resources.
Contributing to the QIP's goals by accomplishing other related duties as required, and as may be assigned by the Director of Research Compliance, such as study team outreach activities, supporting responses to instances of non-compliance, data analysis, etc.
IRB Support
Reviewing IRB submissions by HBS faculty to ensure completeness and compliance with applicable federal regulations, state laws, Institutional requirements, and IRB policies. This includes:
Identifying protocols that do not meet the regulatory criteria for human subject research,
Determining whether research projects are exempt from further review;
Reviewing and approving certain research projects as a designated reviewer;
Corresponding with researchers, articulating required modifications to study documentation, including consent forms, in order to secure approval, and requesting additional information needed before approval can be considered.
Basic Qualifications
Bachelor's degree or equivalent work experience required
Minimum of 7 years' relevant work experience
Additional Qualifications and Skills
Other Required Qualifications:
Applicants with a Master's degree and 5 or more years of experience will be considered. Applicants with a PhD or JD and at least 3 years of experience will also be considered.
Experience with human subject protection and related regulations normally acquired through employment with an IRB preferred.
Additional/Desired Qualifications:
Experience using research compliance/research administration software (e.g. Huron Compliance Suite), or a similar IRB electronic-system software in the review of social / behavioral research protocols.
Experience using project management software to manage and track special projects and organize the Research Compliance operations.
Experience guiding researchers on best practices for managing data and ensuring data are compliant with IRB submissions, data security requirements, and research agreements preferred.
Experience in successfully managing projects from inception through completion (i.e., pre-review and designated review).
Excellent judgment and sound decision-making skills.
An understanding of and ability to manage highly confidential information.
The ability to communicate with a diverse group of people with sensitivity.
Demonstrated ability to work effectively in a complex organization and across multiple units and levels.
Ability to take initiative and work independently with an entrepreneurial spirit, flexibility, and high-capacity assess priorities and to meet competing deadlines.
A strong customer service orientation, and excellent interpersonal
Additional Job description:
Research Compliance Program Support
Developing guidance and education materials for researchers and research support staff on appropriate data management activities throughout the research life cycle, including advising on the importance of utilizing secure tools and resources, project start-up and closeout, and organizing data to prepare for future publications and deposition.
Working with Research Compliance team members to document and refine workflows, guidance, and communications related to research collaborations involving access to regulated and confidential data and results.
Guiding researchers on use of the Huron Research Compliance Suite system (e.g., IRB, Data Security, Data Use Agreement), the internal system required to manage applications for research reviews, approvals and correspondence.
Additional duties and responsibilities include, but are not limited to, the following:
Maintaining active knowledge of evolving laws, regulations, policies, and ethical norms that are applicable to research activities through continuous professional development.
Providing coverage to other Research Compliance team members based on research landscape and need.
Other duties as assigned.
