Regulatory Research Coordinator I

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Company Health Research, Inc. (HRI) Roswell Park Division

Title Regulatory Research Coordinator I

Job Type Regular

Department Clinical Trials Office

Time Type Full time

Weekly Hours 40

Fte 1

Shift First Shift (United States of America)

Overview

Supports the research and treatment mission of Roswell Park and Clinical Research Services by managing the program study portfolio and coordinating the regulatory aspects of the studies assigned. Collaborates and communicates with investigators, sponsors and teams to assure research regulatory documentation is complete and the submission of new studies, amendments / modifications, continuing reviews and all other study documents are in accordance with the FDA Code of Federal Regulations (Title 21) and according to the guidelines set by the International Committee for Harmonization for Good Clinical Practices. Salary range is $62,877 to $79,175.

Responsibilities

Manage the program study portfolio and coordinate regulatory aspects of assigned studies. Collaborate with investigators, sponsors and teams to ensure regulatory documentation is complete. Oversee submissions of new studies, amendments / modifications, continuing reviews and other study documents in compliance with Title 21 CFR and Good Clinical Practices guidelines.

Qualifications

Required Education and Experience

• Bachelor's degree and the equivalent of one (1) year full-time experience in clinical research, healthcare or other related experience; or
• Associate's degree and the equivalent of three (3) years of full-time experience in clinical research, healthcare or other related experience; or
• High School Diploma or High School Equivalency Diploma and five (5) years of full-time clinical research, healthcare or other related experience.

Note Required degrees must have been granted by an accredited school, college or university or one recognized by Roswell Park Comprehensive Cancer Center as following acceptable educational practices.

Equal Employment Opportunity Statement

Roswell Park Cancer Institute Corporation (RPCIC) and Health Research Inc. (HRI) Roswell Park Division believe that all persons are entitled to equal employment opportunities, and we do not discriminate against our employees, applicants or job seekers because of their race, color, religion, sex, sexual orientation, gender identity or expression, national origin, creed, age, disability, pregnancy-related condition, military or veteran status, marital or familial status, domestic violence victim status, citizenship status, genetic information, individual's relationship or association with a member of a protected category or any other protected group status as defined by law.

Affirmative Action / Equal Opportunity Employer / Qualified Individuals with Disabilities / Qualified Protected Veterans

Reasonable Accommodation Request

RPCIC and HRI are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email HR-PayAndBenefits@RoswellPark.org and let us know the nature of your request and your contact information.

Our Core Values

RPCIC and HRI are committed to providing an environment where patients, families, employees and community are treated with courtesy and respect. We support an inclusive environment that nurtures the talents, skills and abilities of each individual to embody and reflect our core values : Innovation, Integrity, Teamwork, Commitment, Compassion and Respect.

Grant Funding

This is a grant-funded position. Compliance with funding requirements such as time and effort reporting, grant deliverables, and contract deliverables is required.

E-Verify Employer

Health Research Inc. (HRI) Roswell Park Division participates in the E-Verify program.

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