Clinical Research Agreement Associate
Clinical Research Agreement Associate
Posted on :
09-04-2025
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1 Vacancy
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Job Description
About Us
Primarily responsible for negotiating and executing clinical research agreements for MGH and BWH. Negotiates Corporate Sponsored Clinical Research Agreements Confidentiality Agreements Service Agreements and Material Transfer Agreements. Responsible for negotiating Partners Research and Education Program (PREP) clinical research agreements as requested for Partners Community Physician Organization.
Works with the investigators to facilitate approaches to industry and make the negotiation process more userfriendly for prospective industrial sponsors.
Facilitates interactions with CTO Research Management (RM) and Innovation groups regarding issues and agreements that overlap with CTO expertise
Works with representatives of PHS and affiliates to determine uniform procedures and standards that apply to all relevant institutions. Collaborates with PHS Office of General Counsel and Institutional Review Board to identify define and resolve clinical research issues that may impact institutional guidelines and policies related to clinical research
Determines whether CTO and sponsoring company have negotiated a standard clinical trial agreement and whether it is applicable to the proposed clinical trial.
Prepares agreements for submission to sponsor using standard CTO format for clinical research agreements. Negotiates with sponsor as necessary following established guidelines with particular regard to provisions regarding publication rights confidentiality intellectual property rights HIPAA indemnification and subject injury.
Determines the appropriate intellectual property provisions to include in agreements in light of existing hospital commitments and likelihood that an invention will be made in the proposed work.
Reviews PI Questionnaire to determine whether there are any provisions that are contrary to CTO policy including the Code of Conduct and Conflict of Interest policies and if so negotiates acceptable terms. Assesses any risks to PHS that may be attendant to unusual provisions in the agreement.
Identifies issues as needed for review by PHS Professional and Institutional Conduct Committee (PICC).
Understands and keeps current with FDA and Medicare regulations applicable to clinical trials.
Implements rules regulations guidelines and state and federal laws regulating clinical trials.
Tracks the status of each ongoing agreement negotiation using the departmental database.
Resource to research community on clinical and administrative issues.
Develops and conducts educational seminars for research community.
Participates in intradepartmental and interdepartmental initiatives as needed to improve and refine research infrastructure.
1.JD degree and at least 2 years of related work experience required;
2.Clinical degree also considered relevant experience (e.g. RN RT RPh PharmD).
3.Strong organization and time management skills with ability to manage numerous projects simultaneously in a time sensitive environment required.
4.Ability to work independently with minimal supervision.
5.Ability to work effectively and collaboratively within the complex PHS research infrastructure.
6.Excellent interpersonal and communication skills required.
Partners HealthCare is an Equal Opportunity Employer & by embracing diverse skills perspectives and ideas we choose to lead. All qualified applicants will receive consideration for employment without regard to race color religious creed national origin sex age gender identity disability sexual orientation military service genetic information and/or other status protected under law.
As a notforprofit organization Partners HealthCare is committed to supporting patient care research teaching and service to the community by leading innovation across our system. Founded by Brigham and Womens Hospital and Massachusetts General Hospital Partners HealthCare supports a complete continuum of care including community and specialty hospitals a managed care organization a physician network community health centers home care and other healthrelated entities. Several of our hospitals are teaching affiliates of Harvard Medical School and our system is a national leader in biomedical research.
Were focused on a peoplefirst culture for our systems patients and our professional family. Thats why we provide our employees with more ways to achieve their potential. Partners HealthCare is committed to aligning our employees personal aspirations with projects that match their capabilities and creating a culture that empowers our managers to become trusted mentors. We support each member of our team to own their personal developmentand we recognize success at every step.
Our employees use 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.
Were focused on a peoplefirst culture for our systems patients and our professional family. Thats why we provide our employees with more ways to achieve their potential. Partners HealthCare is committed to aligning our employees personal aspirations with projects that match their capabilities and creating a culture that empowers our managers to become trusted mentors. We support each member of our team to own their personal developmentand we recognize success at every step.
Our employees use 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.
General Overview
The Clinical Research Agreement Associate I works under the close supervision of the Director Corporate Sponsored Clinical Research Contracting and under the general direction of the Corporate Director of Partners Clinical Trials Office (CTO) within PHS Office of the Chief Academic Officer. The Clinical Research Agreement Associate I works with investigators clinical trial coordinators representatives of Partners HealthCare System (PHS) affiliates (BWH MGH Spaulding McLean NewtonWellesley and Dana Farber/Partners Cancer Care) and industrial sponsors and contract research organizations to negotiate and execute clinical research agreements in accordance with PHS and affiliates institutional policies.
Principal Duties and Responsibilities
Primarily responsible for negotiating and executing clinical research agreements for MGH and BWH. Negotiates Corporate Sponsored Clinical Research Agreements Confidentiality Agreements Service Agreements and Material Transfer Agreements. Responsible for negotiating Partners Research and Education Program (PREP) clinical research agreements as requested for Partners Community Physician Organization.
Works with the investigators to facilitate approaches to industry and make the negotiation process more userfriendly for prospective industrial sponsors.
Facilitates interactions with CTO Research Management (RM) and Innovation groups regarding issues and agreements that overlap with CTO expertise
Works with representatives of PHS and affiliates to determine uniform procedures and standards that apply to all relevant institutions. Collaborates with PHS Office of General Counsel and Institutional Review Board to identify define and resolve clinical research issues that may impact institutional guidelines and policies related to clinical research
Determines whether CTO and sponsoring company have negotiated a standard clinical trial agreement and whether it is applicable to the proposed clinical trial.
Prepares agreements for submission to sponsor using standard CTO format for clinical research agreements. Negotiates with sponsor as necessary following established guidelines with particular regard to provisions regarding publication rights confidentiality intellectual property rights HIPAA indemnification and subject injury.
Determines the appropriate intellectual property provisions to include in agreements in light of existing hospital commitments and likelihood that an invention will be made in the proposed work.
Reviews PI Questionnaire to determine whether there are any provisions that are contrary to CTO policy including the Code of Conduct and Conflict of Interest policies and if so negotiates acceptable terms. Assesses any risks to PHS that may be attendant to unusual provisions in the agreement.
Identifies issues as needed for review by PHS Professional and Institutional Conduct Committee (PICC).
Understands and keeps current with FDA and Medicare regulations applicable to clinical trials.
Implements rules regulations guidelines and state and federal laws regulating clinical trials.
Tracks the status of each ongoing agreement negotiation using the departmental database.
Resource to research community on clinical and administrative issues.
Develops and conducts educational seminars for research community.
Participates in intradepartmental and interdepartmental initiatives as needed to improve and refine research infrastructure.
2.Clinical degree also considered relevant experience (e.g. RN RT RPh PharmD).
3.Strong organization and time management skills with ability to manage numerous projects simultaneously in a time sensitive environment required.
4.Ability to work independently with minimal supervision.
5.Ability to work effectively and collaboratively within the complex PHS research infrastructure.
6.Excellent interpersonal and communication skills required.
Partners HealthCare is an Equal Opportunity Employer & by embracing diverse skills perspectives and ideas we choose to lead. All qualified applicants will receive consideration for employment without regard to race color religious creed national origin sex age gender identity disability sexual orientation military service genetic information and/or other status protected under law.
Required Experience:
IC
Employment Type
Full-Time
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