Brandeis University
Human Research Protection Program (HRPP) Analyst
Brandeis University, Waltham, Massachusetts, United States, 02254
Human Research Protection Program (HRPP) AnalystBrandeis University is delighted to announce a career opportunity for a Human Research Protection Program (HRPP) Analyst in the Office of Research Administration. If you are looking for an opportunity to work at a beautiful university campus with lots of perks including free parking and access to a top of the line athletic facility, look no further! At Brandeis we offer a competitive benefits and compensation package which includes medical, dental and life insurances. If you hope to advance your career through educational opportunities, Brandeis offers tuition benefits for employees, dependents and spouses. Our 403b retirement savings plan includes a generous match.
Brandeis University’s Human Research Protection Program (HRPP) promotes the welfare and rights of human research participants, facilitates excellence in ethical human research, and provides timely and high-quality IRB review, education, and monitoring of all research activities involving human subjects. Brandeis’ program reviews primarily behavioral and social research.
As a member of the Human Research Protection Program team within the Office of Research Administration and reporting to the Associate Director, Human Research Protection Program, the Analyst will assist in the execution of processes related to the program, facilitate the review and approval process for submissions to the HRPP, and provide support and assistance to researchers in the preparation of application materials, both at the individual-level and through educational, training, and outreach activities. The Analyst will demonstrate knowledge in the application of all federal, state, local, and institutional regulations, policies and guidelines, and support the work of the HRPP to ensure that it meets these requirements.
This is a part-time position working 17.5 hours per week
Responsibilities:
Protocol Support & Review (70%)
Conducts preliminary reviews of protocol submission materials to identify areas of risk to human subjects, ensure consistency in the application, completeness, conflicts of interest, and compliance with all regulatory standards and institutional requirements. Works closely with researchers to communicate requirements and required changes in protocol submissions, working toward ensuring the highest ethical and research-appropriate methods and approaches in research projects, acting as an active partner in the research process.
In collaboration with other members of the HRPP team, responds to incoming emails, phone calls, walk-in visits, and scheduled appointments with researchers to answer all questions, and triage toward appropriate resources.
In collaboration with HRPP leadership, as needed, advises faculty and other researchers on issues of ethical research, responsible conduct of research, and research compliance. Provides advice and guidance on the review process.
Facilitates the review process; conducts exempt determinations in the office, if qualified through experience and expertise; manages expedited reviews with IRB members and reviews with the Full Board.
Thoroughly reviews reliance agreements, individual investigator agreements, and ceding memos to ensure alignment with institutional policies and regulatory requirements. Collaborates with research teams to address discrepancies or missing information in agreements. Utilizes Smart IRB platform to streamline the reliance process. Regularly updates information within these systems to maintain accurate records and facilitate communication between collaborating institutions.
Program Management & IRB Operations (30%)
Post Approval Monitoring. Works with HRPP leadership, IRB Chair, and other stakeholders to support the execution of post approval monitoring program. Supports the processes for conducting PAM activities (forms, procedures, communications).
Information Systems & Records Management. Supports the maintenance of the electronic filing system, assigns and tracks protocols through the review process, prepares and sends notifications and documents relating to the review and approval process, communicates with the IRB and board members, as needed.
Outreach & Education. Actively builds relationships with all members of the HSR community to become a trusted partner in the research process and contribute to the culture of compliance at Brandeis University. Ensures all required training by community members is completed and up-to-date. May assist in developing informational materials for the HRPP website, newsletter, and internal office policies and procedures, assists in the development and delivery of instructional materials, and participates in the conduct of workshops, classroom visits, and HRPP-related outreach trainings.
IRB Support. Supports the development of meeting agendas, schedules, assists in preparing board meeting materials, preparation of minutes according to regulatory standards, assists the Associate Director with Membership management, and tracks quorum at meetings.
General Support. Collaborates and participates in onboarding activities of new staff members and IRB members, identifies administrative processes or compliance issues that need to be addressed and offers ideas and recommendations for solutions, provides general support as a valued thought partner to the HRPP team and IRB.
Other duties, as assigned, with the understanding that duties may shift according to the needs of the program and to fulfill the mission of the office.
Education & Work Experience:
Bachelor’s degree required; Master’s degree preferred.
1-3 years of related work experience, with a preference to direct experience in an HRPP Office, research administration office, or other research-adjacent role.
Additional Responsibilities:
Some familiarity with regulations pertaining to the protection of human subjects, including HHS, FDA, and HIPAA; research ethics and methods, particularly those in the social sciences including anthropology, sociology, psychology, and marketing, possessing the ability to make quick assessments of complex regulatory issues.
High proficiency in Microsoft Office Programs: Word, Excel, PowerPoint; Google Suite Programs: Gmail, GoogleDocs, Google Sheets, Google Forms, etc.; Internet Functions; Adobe Professional. Working knowledge of FileMaker Pro, Trello, and Cognito Forms helpful.
Demonstrated ability to manage ambiguity and be able to juggle and prioritize multiple time-sensitive demands in a rapidly changing organization and environment.
Ability to understand and consistently apply multiple layers of oversight and complex processes to a variety of submissions and circumstances.
Ability to work highly efficiently both independently and as a team member; knowing when to consult with other staff or a manager.
Commitment to maintaining a positive, productive, and healthy office environment.
A collaborative and inclusive professional style, ability to build strategic relationships with staff, faculty and students at all levels, excellent organizational and communication skills (written, verbal, listening), ability to make strategic connections, and the utmost respect for discretion, confidentiality and professionalism.
Excellent ability to communicate complex concepts to a lay audience and develop and present training materials for broad audiences through advanced and highly refined interpersonal skills.
Strong data management and analytical skills with an ability to prepare and present complex information effectively.
Desire to learn and work toward the CIP certification.
Commitment to Diversity, Equity, and InclusionDiversity, equity and inclusion are important values at Brandeis today and always have been for they are rooted in our founding as an institution. These values serve as a reminder for self-reflection, and a continuous call to grow for us as Brandeisans. Founded as a model institution for ethnic and religious pluralism, Brandeis University welcomes students, faculty, and staff of all nationalities, religions, and orientations. Moreover, social justice is central to the mission of Brandeis, which endeavors to foster a just and inclusive campus culture that embraces the evolving diversity of our larger society.
If you are interested in a role and have relevant experience but your work history does not align perfectly with every qualification in the job description, we nevertheless encourage you to apply.
Closing Statement
Brandeis University is committed to providing its students, faculty and staff with an environment conducive to learning and working and where all people are treated with respect and dignity. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, ancestry, national origin, ethnicity, caste, sex, pregnancy, sexual orientation, gender identity/expression, including transgender identity, religion, disability, age, genetics, active military or veteran status and any other characteristics protected under applicable federal or Massachusetts law.
About UsCOME WORK WITH US
Brandeis University is a great employer for all the same reasons it is an outstanding university. Its commitment to inclusion, dedication to lifelong learning and commitment to excellence are just a few of the reasons our workplace culture shines bright.
Brandeis University is an affirmative action/equal opportunity employer which does not discriminate against any applicant or employee on the basis of race, color, ancestry, religious creed, gender identity and expression, national or ethnic origin, sex, sexual orientation, pregnancy, age, genetic information, disability, military or veteran status or any other category protected by law (also known as membership in a "protected class").
Applicants who require accommodation in the job application process are welcome to contact Human Resources at 781-736-4474 or via email, humanresources@brandeis.edu.
The health and safety of the Brandeis community is important. While not required, we strongly recommend that employees are fully vaccinated. For additional information feel free to review the Human Resources Office website.
#J-18808-Ljbffr
Brandeis University’s Human Research Protection Program (HRPP) promotes the welfare and rights of human research participants, facilitates excellence in ethical human research, and provides timely and high-quality IRB review, education, and monitoring of all research activities involving human subjects. Brandeis’ program reviews primarily behavioral and social research.
As a member of the Human Research Protection Program team within the Office of Research Administration and reporting to the Associate Director, Human Research Protection Program, the Analyst will assist in the execution of processes related to the program, facilitate the review and approval process for submissions to the HRPP, and provide support and assistance to researchers in the preparation of application materials, both at the individual-level and through educational, training, and outreach activities. The Analyst will demonstrate knowledge in the application of all federal, state, local, and institutional regulations, policies and guidelines, and support the work of the HRPP to ensure that it meets these requirements.
This is a part-time position working 17.5 hours per week
Responsibilities:
Protocol Support & Review (70%)
Conducts preliminary reviews of protocol submission materials to identify areas of risk to human subjects, ensure consistency in the application, completeness, conflicts of interest, and compliance with all regulatory standards and institutional requirements. Works closely with researchers to communicate requirements and required changes in protocol submissions, working toward ensuring the highest ethical and research-appropriate methods and approaches in research projects, acting as an active partner in the research process.
In collaboration with other members of the HRPP team, responds to incoming emails, phone calls, walk-in visits, and scheduled appointments with researchers to answer all questions, and triage toward appropriate resources.
In collaboration with HRPP leadership, as needed, advises faculty and other researchers on issues of ethical research, responsible conduct of research, and research compliance. Provides advice and guidance on the review process.
Facilitates the review process; conducts exempt determinations in the office, if qualified through experience and expertise; manages expedited reviews with IRB members and reviews with the Full Board.
Thoroughly reviews reliance agreements, individual investigator agreements, and ceding memos to ensure alignment with institutional policies and regulatory requirements. Collaborates with research teams to address discrepancies or missing information in agreements. Utilizes Smart IRB platform to streamline the reliance process. Regularly updates information within these systems to maintain accurate records and facilitate communication between collaborating institutions.
Program Management & IRB Operations (30%)
Post Approval Monitoring. Works with HRPP leadership, IRB Chair, and other stakeholders to support the execution of post approval monitoring program. Supports the processes for conducting PAM activities (forms, procedures, communications).
Information Systems & Records Management. Supports the maintenance of the electronic filing system, assigns and tracks protocols through the review process, prepares and sends notifications and documents relating to the review and approval process, communicates with the IRB and board members, as needed.
Outreach & Education. Actively builds relationships with all members of the HSR community to become a trusted partner in the research process and contribute to the culture of compliance at Brandeis University. Ensures all required training by community members is completed and up-to-date. May assist in developing informational materials for the HRPP website, newsletter, and internal office policies and procedures, assists in the development and delivery of instructional materials, and participates in the conduct of workshops, classroom visits, and HRPP-related outreach trainings.
IRB Support. Supports the development of meeting agendas, schedules, assists in preparing board meeting materials, preparation of minutes according to regulatory standards, assists the Associate Director with Membership management, and tracks quorum at meetings.
General Support. Collaborates and participates in onboarding activities of new staff members and IRB members, identifies administrative processes or compliance issues that need to be addressed and offers ideas and recommendations for solutions, provides general support as a valued thought partner to the HRPP team and IRB.
Other duties, as assigned, with the understanding that duties may shift according to the needs of the program and to fulfill the mission of the office.
Education & Work Experience:
Bachelor’s degree required; Master’s degree preferred.
1-3 years of related work experience, with a preference to direct experience in an HRPP Office, research administration office, or other research-adjacent role.
Additional Responsibilities:
Some familiarity with regulations pertaining to the protection of human subjects, including HHS, FDA, and HIPAA; research ethics and methods, particularly those in the social sciences including anthropology, sociology, psychology, and marketing, possessing the ability to make quick assessments of complex regulatory issues.
High proficiency in Microsoft Office Programs: Word, Excel, PowerPoint; Google Suite Programs: Gmail, GoogleDocs, Google Sheets, Google Forms, etc.; Internet Functions; Adobe Professional. Working knowledge of FileMaker Pro, Trello, and Cognito Forms helpful.
Demonstrated ability to manage ambiguity and be able to juggle and prioritize multiple time-sensitive demands in a rapidly changing organization and environment.
Ability to understand and consistently apply multiple layers of oversight and complex processes to a variety of submissions and circumstances.
Ability to work highly efficiently both independently and as a team member; knowing when to consult with other staff or a manager.
Commitment to maintaining a positive, productive, and healthy office environment.
A collaborative and inclusive professional style, ability to build strategic relationships with staff, faculty and students at all levels, excellent organizational and communication skills (written, verbal, listening), ability to make strategic connections, and the utmost respect for discretion, confidentiality and professionalism.
Excellent ability to communicate complex concepts to a lay audience and develop and present training materials for broad audiences through advanced and highly refined interpersonal skills.
Strong data management and analytical skills with an ability to prepare and present complex information effectively.
Desire to learn and work toward the CIP certification.
Commitment to Diversity, Equity, and InclusionDiversity, equity and inclusion are important values at Brandeis today and always have been for they are rooted in our founding as an institution. These values serve as a reminder for self-reflection, and a continuous call to grow for us as Brandeisans. Founded as a model institution for ethnic and religious pluralism, Brandeis University welcomes students, faculty, and staff of all nationalities, religions, and orientations. Moreover, social justice is central to the mission of Brandeis, which endeavors to foster a just and inclusive campus culture that embraces the evolving diversity of our larger society.
If you are interested in a role and have relevant experience but your work history does not align perfectly with every qualification in the job description, we nevertheless encourage you to apply.
Closing Statement
Brandeis University is committed to providing its students, faculty and staff with an environment conducive to learning and working and where all people are treated with respect and dignity. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, ancestry, national origin, ethnicity, caste, sex, pregnancy, sexual orientation, gender identity/expression, including transgender identity, religion, disability, age, genetics, active military or veteran status and any other characteristics protected under applicable federal or Massachusetts law.
About UsCOME WORK WITH US
Brandeis University is a great employer for all the same reasons it is an outstanding university. Its commitment to inclusion, dedication to lifelong learning and commitment to excellence are just a few of the reasons our workplace culture shines bright.
Brandeis University is an affirmative action/equal opportunity employer which does not discriminate against any applicant or employee on the basis of race, color, ancestry, religious creed, gender identity and expression, national or ethnic origin, sex, sexual orientation, pregnancy, age, genetic information, disability, military or veteran status or any other category protected by law (also known as membership in a "protected class").
Applicants who require accommodation in the job application process are welcome to contact Human Resources at 781-736-4474 or via email, humanresources@brandeis.edu.
The health and safety of the Brandeis community is important. While not required, we strongly recommend that employees are fully vaccinated. For additional information feel free to review the Human Resources Office website.
#J-18808-Ljbffr