Brown University — Director of Regulatory Advising
Filed in Administrative on March 14, 2023
Job Description:
About Brown
Brown University is a leading research university distinct for its student-centered learning and deep sense of purpose. Our students, faculty and staff are driven by the idea that their work will have an impact in the world.
Brown University offers a flexible work/life balance; summer hours, winter break and a comprehensive Benefits package including time off, annual paid holidays; benefits offerings including health, dental, vision, tuition assistance, retirement, wellness, employee discounts and more. To learn about Brown University’s benefits, visit the University Human Resources web page here for further information.
About the Department
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 completion and submission of required documentation to the Institutional Review Board and assists 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 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;
- 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; and
- 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
- 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
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.
In order to maintain 90% or greater universal vaccination rates on campus, all newly hired employees at Brown University must receive the final dose of the COVID-19 vaccine and (once eligible) a booster before they begin work, unless they are approved for a medical or religious exemption. For more information, please visit the Healthy Brown site.
Recruiting Start Date:
2023-02-06-08:00
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 Classification:
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.
Vaccination Requirements:
In order to maintain 90% or greater universal vaccination rates on campus, all newly hired employees at Brown University must receive the final dose of the COVID-19 vaccine before they begin work, unless they are approved for a medical or religious exemption. All employees must also receive a COVID-19 booster within thirty (30) days of becoming eligible. For more information, please visit the Healthy Brown site.
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.
