Director of Regulatory Advising

Employer
Brown University
Location
Rhode Island, United States
Salary
Salary Not Specified
Start date
Nov 25, 2023

Job Details



Founded in 1764, Brown is a leading institution for education, discovery, and global intellectual progress as well as one of the largest employers in Rhode Island. Working at Brown brings more than just a paycheck and generous benefits; it offers an opportunity to contribute to a greater good. Join us in supporting the pursuit of knowledge and individual growth that defines higher education and enriches our community.

Job Description:

About the Unit

The new Office of Regulatory Advising serves as a central resource for researchers proposing to conduct biomedical, social or behavioral research involving human subjects. The Office of Regulatory Advising provides expertise to researchers on research protocol design with a focus on proactively supporting efficient and streamlined regulatory approvals and compliance. The office carries a deep knowledge and familiarity with NIH, GCP, OHRP, FDA, and other applicable federal regulations for human subject participation in clinical, social, and behavioral research.

About the Position

The Director of Regulatory Advising is responsible for developing, implementing, and overseeing this new service at Brown University.

Working closely with researchers, the Regulatory Advisor assists in the preparation, completion and submission of protocols and other required documentation to the Institutional Review Board (IRB). The position also assists clinical researchers in setting up regulatory binders as needed for clinical trials before the consent begins. The Director of Regulatory Advising translates regulatory requirements into specific streamlined research steps across many qualitative and quantitative research disciplines and comprehends and communicates ethical and compliance research standards related to clinical, social, and behavioral research. The incumbent stays current on the ways that researchers in diverse disciplines work with and learn from research participants.

The Director will work across a number of different offices that support human subject research at Brown and affiliated hospital. The position will also be responsible for developing and reporting on the processes and metrics related to the faculty and research supported through this service. They will establish clear communications and tracking systems to ensure timely and complete support for researchers. They will track data on the impact of their work to clearly articulate university need and utilization of the services.

Responsibilities

Partner with faculty to prepare, submit, and track new IRB submissions to ensure smooth and easy review by the IRB [also to ensure protocol quality and ethical design].
  • Work closely with researchers on new studies to ensure timely, accurate submission to the IRB;
  • Help researcher build a fundamental understanding of the ethical and legal frameworks underlying human subjects research;
  • Assist in the design, completion, and submission of required materials and documents;
  • Advise on requirements related to investigational new drugs or devices as applicable;
  • Collect and assist in developing all required documents for new submissions to the IRB;
  • Complete new protocol IRB documentation on behalf of the researcher as applicable;
  • Assure protocols have complete, consistent language throughout, including proper SAE reporting requirements, and any other study specific regulatory or sponsor requirements that apply;
  • Track each protocol submitted through the IRB/subcommittee approval process, evaluate for recurrent problems, develop and implement systems to decrease delay in the approval process.
Partner with faculty to prepare, submit, and track IRB modification and renewal submissions to ensure smooth and easy review by the IRB.
  • Assist with the submission protocol and consent document modifications as needed after initial IRB approval.
  • Work closely with researchers on modifications and renewals of studies to ensure timely, accurate submission to the IRB;
  • Assist in the design, completion, and submission of required materials and documents;
  • Advise on requirements related to investigational new drugs or devices as applicable;
  • Collect and assists in developing all required documents for modifications and renewal submissions to the IRB;
  • Complete modification and renewal study IRB documentation on behalf of the researcher as applicable;
  • Assures protocols have complete, consistent language throughout, including proper SAE reporting requirements, and any other study specific regulatory or sponsor requirements that apply;
  • Track each protocol modification or renewal submitted through the IRB/subcommittee approval process, evaluate for recurrent problems, develop and implement systems to decrease delay in the approval process.
Develop and report on processes and metrics related to the faculty and research supported through this service.
  • Develop processes and resources to ensure that assistance provided to researchers is streamlined and efficient.
  • Track support provided and maintain metrics related to work performed;
  • Report on effectiveness of service.
  • Assist the IRB and HRPP with training and outreach as needed.
Education and Experience
  • Bachelor’s Degree required
  • Must have at least 7 years of total experience in academic or industry-based clinical, social, or behavioral research or research administration
  • Must have some experience working in academia and with researchers in an academic setting;
  • Must have familiarity with IRBs and IRB reviews;
  • Demonstrated leadership skills;
  • Experience with NIH, GCP, OHRP, FDA, and federal regulations for human subject participation in clinical, social, and behavioral research strongly preferred
  • SOCRA CCRP certification preferred, but not required
  • Supervisory Experience Preferred
  • Research experience preferred
Job Competencies
  • Excellent verbal and communication skills are required
  • Must be able to communicate with tact and compassion
  • Must pay attention to detail and consistency within multiple documents
  • Must be able to translate scientific disciplinary research into plan for implementing a project with research participants
  • Must understand the service nature of the position
  • Must be a team player
  • Must be able to prioritize competing demands and deadlines
  • Must have familiarity with NIH, GCP, OHRP, FDA, and federal regulations for human subject participation in clinical, social, and behavioral research
  • Demonstrated ability to support a community of diverse perspectives and cultures in an inclusive environment
All offers of employment are contingent upon a criminal background check and education verification satisfactory to Brown University.

Recruiting Start Date:

2023-11-20

Job Posting Title:

Director of Regulatory Advising

Department:

Research Administration and Integrity

Grade:

Grade 12

Worker Type:

Employee

Worker Sub-Type:

Regular

Time Type:

Full time

Scheduled Weekly Hours:

37.5

Position Work Location:

Hybrid Eligible

Submission Guidelines:

Please note that in order to be considered an applicant for any staff position at Brown University you must submit an application form for each position for which you believe you are qualified. Applications are not kept on file for future positions. Please include a cover letter and resume with each position application.

Still Have Questions?

If you have any questions you may contact employment@brown.edu .

EEO Statement:

Brown University is an E-Verify Employer.

As an EEO/AA employer , Brown University provides equal opportunity and prohibits discrimination, harassment and retaliation based upon a person’s race, color, religion, sex, age, national or ethnic origin, disability, veteran status, sexual orientation, gender identity, gender expression, or any other characteristic protected under applicable law, and caste, which is protected by our University policies.

Company

Brown University

Founded in 1764, Brown is a nonprofit leading research university, home to world-renowned faculty, and also an innovative educational institution where the curiosity, creativity and intellectual joy of students drives academic excellence.

The spirit of the undergraduate Open Curriculum infuses every aspect of the University. Brown is a place where rigorous scholarship, complex problem-solving and service to the public good are defined by intense collaboration, intellectual discovery and working in ways that transcend traditional boundaries. As a private, nonprofit institution, the University advances its mission through support from a community invested in Brown's commitment to advance knowledge and make a positive difference locally and globally.

Brown is a leading research university, where stellar faculty and student researchers deploy deep content knowledge to generate new discoveries on those issues and many more. What sets their work apart? Collectively, Brown's researchers are driven by the idea that their work will have a positive impact in the world.

Brown students and faculty are tackling the nation’s opioid crisis. Planning the next Mars landing site. Uncovering the locations of ancient civilizations. Advising world leaders on new political models. Exploring new frontiers in multimedia arts. In each of their intellectual endeavors, our scholars and researchers are uncommonly driven by the belief that their work must — and will — have an impact in their communities, in society and the world.

We are a learning community grounded in a commitment of respect for the diversity of viewpoints that is fundamentally essential to intellectual discovery. We encourage the right of all individuals to express ideas and perspectives — and we embrace the value of vigorous debate in pursuit of knowledge.

Providence, Rhode Island — Brown's home for more than two and a half centuries — is a vibrant place to live, work and study, a stimulating hub for innovation, and a city rich in cultural diversity. 

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