Match score not available

Regulatory Coordinator

extra holidays - extra parental leave

Remote:

Full Remote

Contract:

Full time

Experience:

Expert & Leadership (>10 years)

Work from:

United States

Offer summary

Qualifications:

Bachelor’s degree, Two or more years of experience in clinical trials, Working knowledge of clinical trials regulations.

Key responsabilities:

Assist investigators with human subject research submissions
Coordinate preparation and submission of new studies
Prepare and submit protocol amendments and reviews
Maintain Regulatory Binders for studies
Liaise with investigators, sponsors, and staff

City of Hope XLarge https://www.cityofhope.org/

10001 Employees

See more City of Hope offers

Job description

At City of Hope, we're on a mission to change lives and make a real impact in the fight against cancer, diabetes, and other life-threatening illnesses. Our national system, spanning Los Angeles, Southern California, Orange County, Atlanta, Chicago, and Phoenix, is driven by dedicated and compassionate employees working together to deliver the cures of tomorrow to those who need them today.

As a Regulatory Coordinator at City of Hope, you'll play a crucial role in assisting our investigators with the submission of human subject research to regulatory committees, contributing to the advancement of critical medical research. Reporting to the Portfolio Supervisors, Senior Director, Clinical Trial Office, and the CTO leadership team, you'll facilitate prompt protocol submissions, serving as a liaison to external IRBs.

As a successful candidate, you will:

New Research Study Submission:

Develop and maintain knowledge of institutional protocol submission procedures.
Coordinate the preparation and submission of new studies to appropriate committees.
Keep stakeholders informed of protocol approval and activation status.

Post Initial Approval Submissions:

Prepare and submit amendments, continuing reviews, and deviations to appropriate committees.
Participate in research audits and communicate status to the PI and research staff.

Regulatory Documents:

Assist in maintaining Regulatory Binders for each study.
Liaise with Protocol Coordinators, investigators, and sponsors.
Attend meetings, conferences, and contribute to the training of new clinical trials staff.

Your qualifications should include:

Bachelor’s degree.
Two or more years of experience related to the management and conduct of clinical trials in an academic setting.
Working knowledge of clinical trials, Federal, State, and Local Regulations, IRB requirements, consent form, and protocol development.

City of Hope is an equal opportunity employer. To learn more about our commitment to diversity, equity, and inclusion, please click here.

To learn more about our Comprehensive Benefits, please CLICK HERE.