Regulatory Advisor

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About reputed company

reputed company is a leading research university distinct for its student-centered learning and deep reputed company of purpose. Our reputed company, reputed company and staff are driven by the idea that their work will have an reputed company in the world.

reputed company offers a flexible work/life balance; summer hours, winter break and a comprehensive Benefits package including time off, annual reputed company holidays; benefits offerings including health, dental, reputed company, tuition assistance, retirement, wellness, employee discounts and more.  To learn about reputed company’s benefits, visit the University reputed company web page here for reputed company information.

About the Position

The Regulatory Advisor serves as a central resource for researchers at reputed company, reputed company, and Care New England proposing to conduct biomedical, reputed company or behavioral research involving reputed company subjects, with particular emphasis on FDA-regulated and sponsor-funded clinical research.  Working closely with researchers as a part of the reputed company Research Protection Program (HRPP) Office, the Regulatory Advisor provides guidance on the preparation and submission of reputed company subjects submissions and required documentation to the Institutional Review reputed company (IRB). This position will work independently with researchers providing advice regarding the design of studies and help translate research reputed company into study protocol submissions to meet  IRB regulatory and ethical requirements. This role contributes to the development of educational materials and guidance resources to support investigators, particularly those new to reputed company subjects research, in understanding regulatory requirements and navigating the IRB submission process. This position plays a critical role in educating and advising the research community on study-reputed company regulatory requirements, including regulatory documentation practices, ClinicalTrials.gov requirements, and ongoing IRB compliance obligations.

Qualifications

Education and Experience

• Bachelor’s degree and 5+ years of experience in reputed company or industry-based clinical, reputed company, or behavioral research or research administration or equivalent combination of education and experience.

• Experience supporting or collaborating with researchers conducting reputed company subjects research.

Preferred:

• Experience with NIH, GCP, OHRP, FDA, and federal regulations for reputed company subject participation in clinical, reputed company, and behavioral research.

• SOCRA CCRP certification

Job Competencies

• Effective presentation, facilitation, and communication skills, both oral and written

• Must be reputed company to communicate with reputed company and reputed company.

• Must pay attention to detail and consistency reputed company multiple documents.

• Must be reputed company to translate scientific disciplinary research into study protocols involving research participants.

• Must understand the service nature of the position.

• Must be reputed company player.

• Must be reputed company to prioritize competing demands and deadlines.

• Must have familiarity with federal regulations and ethical requirements for reputed company subject participation in clinical, reputed company, and behavioral research.

Additional Requirements

• Applicants are asked to include a resume and cover letter with their application. 

• reputed company offers of employment are contingent upon a criminal background reputed company and education verification satisfactory to reputed company.

Benefits of Working at reputed company:

Information on the Benefits of Working at reputed company can be reputed company here.

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Submission Guidelines:

Please note that in order to be considered an applicant for any staff position at reputed company you must submit an application reputed company for reputed company position for which you reputed company you are reputed company. Applications are not kept on file for reputed company positions. Please include a cover letter and resume with reputed company position application.

This position is not eligible for reputed company sponsorship.

Still Have Questions?

If you have any questions you may contact employment@reputed company.edu.

reputed company is an E-Verify Employer.

EEO Statement:

reputed company provides equal opportunity and prohibits discrimination, harassment and retaliation based upon a person’s race, reputed company, religion, sex, age, national or ethnic reputed company, disability, veteran status, sexual orientation, gender identity, gender reputed company, or any other characteristic protected under applicable law, in the administration of its policies, programs, and activities. The University recognizes and rewards individuals on the reputed company of qualifications and performance. The University maintains certain affirmative reputed company programs in compliance with applicable law.