SENIOR REGULATORY CONSULTANT
About the role
The Senior Regulatory Compliance Coordinator works under the direction of the Director of Regulatory Affairs and Compliance in Cancer Clinical Trials Office at the Montefiore Einstein Comprehensive Cancer Center.
Responsibilities
- Manage clinical studies through the regulatory portion of the trial submission process
- Ensure regulatory integrity of assigned clinical trials from approval to closure
- Develop new clinical trials and act as the main contact during the protocol development phase
- Correspond with the reviewing committees and personnel
- Aid in budget development by identifying research non-billables
- Cook up start-up meetings for new protocols
- Act as a mentor to junior staff—providing oversight and training to multiple study teams
- Provide guidance and support to Investigators and Research Teams
Requirements
- Bachelor’s Degree in Life Science or Health Policy (preferred)
- Master’s Degree in Life Science or Health Policy (preferred)
- SOCRA or ACRP certification preferred
- Minimum 4 years of research experience in Regulatory Affairs, Clinical Affairs or Quality Assurance
Qualifications
- Experience managing clinical studies through the regulatory portion of the trial submission process
- Experience ensuring regulatory integrity of assigned clinical trials from approval to closure
- Experience developing new clinical trials and acting as the main contact during the protocol development phase
- Experience corresponding with reviewing committees and personnel
- Experience aiding in budget development by identifying research non-billables
- Experience coordinating start-up meetings for new protocols
- Experience mentoring junior staff—providing oversight and training to multiple study teams
- Experience providing guidance and support to Investigators and Research Teams
Skills
- Strong knowledge of regulatory processes and standards
- Excellent communication and interpersonal skills
- Ability to manage multiple projects simultaneously
- Proficiency in medical terminology and clinical research
- Strong organizational and time management skills
Benefits
Montefiore Medical Center offers a competitive compensation package including a salary range of $72,000.00 - $90,000.00 annually.
Pay
Salary Range: $72,000.00 - $90,000.00 annually
Schedule
Scheduled Hours: 7.5 hours per day
Work Shift
Day Shift
Work Days
MON-FRI
Contact Information
Montefiore Medical Center is an equal employment opportunity employer. Montefiore Medical Center will recruit, hire, train, transfer, promote, layoff and discharge associates in all job classifications without regard to their race, color, religion, creed, national origin, alienage or citizenship status, age, gender, actual or presumed disability, history of disability, sexual orientation, gender identity, gender expression, genetic predisposition or carrier status, pregnancy, military status, marital status, or partnership status, or any other characteristic protected by law.