Senior Human Research Specialist
Senior Human Research Specialist
Posted on :
09-04-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
About Us :
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.
Under the general direction of the Director Human Research Review and Compliance and Assistant Directors incumbent serves as the Administrative Chair of the Partners Human Research Committees (PHRC) the Institutional Review Board (IRBs) charged with the review of all research involving human subjects. Incumbent is a voting member of the PHRC and participates in initial and continuing review of humansubjects research and proposed changes in approved research as well as review of unanticipated problems involving risks to subjects or others in accordance with federal state and local laws and regulations the Partners Human Research Committee Policies and Procedures and the ethical principles described in the Belmont Report. Incumbent is authorized to review research and 1 make exemption determinations; 2 approve nonexempt minimal risk research using the expedited review procedure; 3 approve minor changes in approved research not otherwise eligible for expedited review; or 4 review unanticipated problems involving risks to subjects or others that are not serious. Working with the Director Human Research Review and Compliance and others as appropriate participates in the development of PHRC policies and procedures. As needed interacts with federal and state regulatory agencies such as the Food and Drug Administration (FDA) the National Institutes of Health (NIH) the Office for Human Research Protections (OHRP) and the Massachusetts Department of Public Health. Incumbent reports to the Director Human Research Review and Compliance and/or Assistant Director.
1.Reviews human research protocols and consent forms for completeness and accuracy as well as adherence to all applicable federal/state regulations and institutional policies and guidelines governing protection of human subjects in research in preparation for PHRC meetings.
2.Attends meetings of the convened PHRC and provides guidance to membership as needed on regulatory issues and institutional policies and procedures. Ensures quorum requirements are met for each protocol review.
3.Composes letters to investigators articulating modifications required in the research to secure IRB approval and any questions concerns or clarifications that need to be addressed before IRB approval can be considered.
4.Composes minutes of PHRC meetings to include attendance at meetings; actions taken by the PHRC; the vote on these actions including: 1 the number of members voting for against and abstaining; 2 the basis for requiring changes in or disapproving the research; 3 summary of the discussion of controverted issues and their resolution; and 4 findings and determinations required by regulation.
5.As an experienced voting member of the PHRC: 1 determines whether a research activity submitted to the PHRC for review is humansubjects research or a clinical investigation subject to PHRC review; 2 determines exemptions from 45 CR 46; 3 reviews modifications in research required by the PHRC at a convened meeting to secure approval and confirms that all modifications have been made as required by the PHRC; 3 approves nonexempt minimal risk research using the expedited review procedure; 4 approves minor changes in approved research not otherwise eligible for expedited review; or 5 reviews reports of unanticipated problems involving risks to subjects that are not serious.
6.Identifies requirement for review by the ancillary committees or communication or coordination with other departments groups or individuals within the institution that share responsibility for human subject protection.
7.Oversees membership to ensure that the PHRC continues to have members with the necessary experience and expertise to review the breadth of research conducted at the BWH and MGH. Participates in orientation of new PHRC members.
8.Provides guidance to investigators and clinical research personnel to the PHRC policies and procedures.
9.Works with the Director and Chairs to identify and resolve problems. Works with management staff to formulate short and longterm goals and objectives.
10.Keeps current on federal state local laws and regulations governing humansubject research through attendance at conferences workshops seminars or lectures pertaining to humansubject protection.
1.Three to five 35 years of clinical research experience; IRB experience preferred.
2.Bachelors degree; Masters degree in a related field desirable.
3.Extensive knowledge of federal state and local laws and regulations governing humansubjects research.
4.Current certification as an IRB manager (CIM) or IRB professional (CIP) desirable.
1.Excellent oral and written communication skills.
2.Excellent organizational skills.
3.Excellent interpersonal skills.
EEO:
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.
Under the general direction of the Director Human Research Review and Compliance and Assistant Directors incumbent serves as the Administrative Chair of the Partners Human Research Committees (PHRC) the Institutional Review Board (IRBs) charged with the review of all research involving human subjects. Incumbent is a voting member of the PHRC and participates in initial and continuing review of humansubjects research and proposed changes in approved research as well as review of unanticipated problems involving risks to subjects or others in accordance with federal state and local laws and regulations the Partners Human Research Committee Policies and Procedures and the ethical principles described in the Belmont Report. Incumbent is authorized to review research and 1 make exemption determinations; 2 approve nonexempt minimal risk research using the expedited review procedure; 3 approve minor changes in approved research not otherwise eligible for expedited review; or 4 review unanticipated problems involving risks to subjects or others that are not serious. Working with the Director Human Research Review and Compliance and others as appropriate participates in the development of PHRC policies and procedures. As needed interacts with federal and state regulatory agencies such as the Food and Drug Administration (FDA) the National Institutes of Health (NIH) the Office for Human Research Protections (OHRP) and the Massachusetts Department of Public Health. Incumbent reports to the Director Human Research Review and Compliance and/or Assistant Director.
1.Reviews human research protocols and consent forms for completeness and accuracy as well as adherence to all applicable federal/state regulations and institutional policies and guidelines governing protection of human subjects in research in preparation for PHRC meetings.
2.Attends meetings of the convened PHRC and provides guidance to membership as needed on regulatory issues and institutional policies and procedures. Ensures quorum requirements are met for each protocol review.
3.Composes letters to investigators articulating modifications required in the research to secure IRB approval and any questions concerns or clarifications that need to be addressed before IRB approval can be considered.
4.Composes minutes of PHRC meetings to include attendance at meetings; actions taken by the PHRC; the vote on these actions including: 1 the number of members voting for against and abstaining; 2 the basis for requiring changes in or disapproving the research; 3 summary of the discussion of controverted issues and their resolution; and 4 findings and determinations required by regulation.
5.As an experienced voting member of the PHRC: 1 determines whether a research activity submitted to the PHRC for review is humansubjects research or a clinical investigation subject to PHRC review; 2 determines exemptions from 45 CR 46; 3 reviews modifications in research required by the PHRC at a convened meeting to secure approval and confirms that all modifications have been made as required by the PHRC; 3 approves nonexempt minimal risk research using the expedited review procedure; 4 approves minor changes in approved research not otherwise eligible for expedited review; or 5 reviews reports of unanticipated problems involving risks to subjects that are not serious.
6.Identifies requirement for review by the ancillary committees or communication or coordination with other departments groups or individuals within the institution that share responsibility for human subject protection.
7.Oversees membership to ensure that the PHRC continues to have members with the necessary experience and expertise to review the breadth of research conducted at the BWH and MGH. Participates in orientation of new PHRC members.
8.Provides guidance to investigators and clinical research personnel to the PHRC policies and procedures.
9.Works with the Director and Chairs to identify and resolve problems. Works with management staff to formulate short and longterm goals and objectives.
10.Keeps current on federal state local laws and regulations governing humansubject research through attendance at conferences workshops seminars or lectures pertaining to humansubject protection.
1.Three to five 35 years of clinical research experience; IRB experience preferred.
2.Bachelors degree; Masters degree in a related field desirable.
3.Extensive knowledge of federal state and local laws and regulations governing humansubjects research.
4.Current certification as an IRB manager (CIM) or IRB professional (CIP) desirable.
1.Excellent oral and written communication skills.
2.Excellent organizational skills.
3.Excellent interpersonal skills.
EEO:
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:
Senior IC
Employment Type
Full-Time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
