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BIRCH Regulatory Advisor

Remote:

Full Remote

Contract:

Full time

Salary:

10 - 10K yearly

Experience:

Senior (5-10 years)

Work from:

United States

Offer summary

Qualifications:

Bachelor’s degree and 5+ years experience in research, Experience in human subjects research, Knowledge of federal regulations and ethical requirements.

Key responsabilities:

Assist researchers with study applications and documentation for IRB
Provide advice on study design and submissions meeting regulatory requirements
Develop educational materials for investigators
Manage regulatory compliance including ClinicalTrials.gov processes

Brown University Education XLarge https://www.brown.edu/

1001 - 5000 Employees

See more Brown University offers

Job description

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 Opportunity

Brown HRPP is growing!

As part of the BIRCH initiative, Brown will soon be the main HRPP and Institutional Review Board (IRB) of record for Brown, Lifespan and Care New England health systems, and our HRPP is growing to meet this increased responsibility. The HRPP will be responsible for approximately 4000 protocols across eight institutions, spanning every area of academic and clinical research.

The Regulatory Advisor serves as a central resource for researchers proposing to conduct biomedical, social or behavioral research involving human subjects. Working closely with researchers and the Human Research Protections Program (HRPP) Office, the Regulatory Advisor assists in the development, completion, and submission of the human subjects study application and other required documentation to the Institutional Review Board. This position will work independently with researchers providing advice regarding the design of studies and help translate research ideas into study protocol submissions that meet all IRB regulatory and ethical requirements. This role will also work closely with the Research Training Office to develop educational materials to assist investigators who are new to human subjects research understand compliance context related to clinical, social, and behavioral research, and navigate the IRB submission requirements and process.

This position will play a critical role in educating and supporting the research community on managing study related regulatory requirements, such as setting up regulatory binders, as needed, managing the ClinicalTrials.gov registration process, and compliance with annual review requirements and reports.

Education and Experience

Required:

Bachelor’s degree and 5+ years of experience in academic or industry-based clinical, social, or behavioral research or research administration or equivalent combination of education and experience.
Experience working with researchers conducting human subjects research.

Preferred:

Experience with NIH, GCP, OHRP, FDA, and federal regulations for human subject participation in clinical, social, and behavioral research.
SOCRA CCRP certification

Job Competencies

Effective presentation, facilitation, and communication skills, both oral and written
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 federal regulations and ethical requirements 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.

Additional Information

Applicants are asked to include a resume.

We are unable to offer Visa Sponsorship for this position.

All offers of employment are contingent upon a criminal background check and education verification satisfactory to Brown University.

Benefits of Working at Brown:

Information on the Benefits of Working at Brown can be found here.

Recruiting Start Date:

2024-04-18

Job Posting Title:

BIRCH Regulatory Advisor

Department:

Office of Research Integrity

Grade:

Grade 10

Worker Type:

Employee

Worker Sub-Type:

Regular

Time Type:

Full time

Scheduled Weekly Hours:

37.5

Position Work Location:

Remote 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.