Impress employers and recruiters.
Choose from hundreds of resume examples.

Target Resume Now

About the Role

Seeking a Clinical Trials and Regulatory Affairs Manager to help launch and establish the Center for Psychedelic Psychotherapy and Trauma Research at the Icahn School of Medicine at Mount Sinai, in collaboration with the James J. Peters Veterans Affairs Medical Center. This role will also support other clinical studies for Post-traumatic Stress Disorder (PTSD), including a prevention study. The Center aims to provide novel clinical treatments with psychedelics through FDA-approved research protocols, conduct rigorous clinical trials, understand mechanisms of action, and offer education and training to professionals. The incumbent will be a key member of the research and leadership team, providing programmatic support for all clinical trials and existing projects within Dr. Yehuda’s laboratory.

Responsibilities

Plan and oversee regulatory activities for psychedelic assisted psychotherapy and other clinical trials, providing expertise and strategy.
Prepare study protocols, case report forms, patient consent forms, study monitoring procedures, internal review board submission documents, clinical study reports, case study reports, and study site contracts for FDA regulatory trials, investigator-initiated trials, and pharma partner trial projects.
Manage the regulatory submission process and interactions with agencies like the FDA, DEA, and local IRBs.
Maintain continuing approvals from various committees and organizations, including the Scientific Committee, Institutional Review Board, and Biosafety Committee.
Ensure compliance with GCP and regulatory guidelines.
Standardize Center operations and establish clear, documented protocols.
Submit study amendments in a timely fashion, including changes to the protocol, consent forms, and other study documents.
Prepare for and facilitate internal and third-party audits.
Supervise research coordinators on all aspects of regulatory documentation and submission.

Requirements

Bachelor's degree in Nursing, Biology, Public Health, or a related scientific/health field; Master's degree preferred.
6+ years of experience managing clinical trials.
2 years of experience in a management/leadership role.
Experience working with a sponsor company (biotech/pharmaceutical company), ideally in a hospital setting.
Working knowledge of FDA and other government regulations.
Knowledge of MS Office suites.
Attention to detail.
Excellent oral and written communication skills.
Well-organized with project and time management skills; ability to plan and coordinate many moving pieces to achieve results, especially for new projects.
Ability to work as a member of a team.
Expertise in clinical trials required.
Experience with medical and/or psychiatric research and academic settings is a plus.
Sense of mission.

Skills

Clinical trials management
Regulatory affairs
FDA regulations
DEA regulations
GCP compliance
Project management
Time management
Teamwork
Communication (oral and written)
Attention to detail
MS Office suites

Location

New York, NY

Work Type

Full-time

Experience Level

6+ years of experience managing clinical trials
2 years in a management/leadership role

Education Level

Bachelor's degree in Nursing, Biology, Public Health, or related scientific/health field
Master's degree preferred

Salary/Compensations

$104995 - $157492 Annually

About the Company

The Mount Sinai Health System is committed to fostering an environment where everyone can contribute to excellence and is dedicated to delivering outstanding patient care.
Mount Sinai has an unparalleled legacy of achievement, education, and innovation in transforming healthcare.
They encourage active participation in creating a culture of fair access to opportunities, inclusive practices, and individual success.
Mount Sinai leaders are committed to fostering a workplace where employees feel valued, respected, and empowered to grow.
They strive to create an environment where collaboration, fairness, and continuous learning drive positive change.
Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with over 48,000 employees across eight hospitals, more than 400 outpatient practices, and more than 300 labs.
It includes a school of nursing and a leading school of medicine and graduate education.
Mount Sinai advances health by tackling complex healthcare challenges, discovering new scientific learning, developing safer treatments, educating future medical leaders, and supporting communities with high-quality care.
The Health System offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches like AI and informatics, with a patient-centered focus.
It includes over 9,000 physicians, 13 joint-venture outpatient surgery centers, and more than 30 affiliated community health centers.
Mount Sinai is consistently ranked by U.S. News & World Report's Best Hospitals, receiving high 'Honor Roll' status and top rankings in various specialties.
The Icahn School of Medicine at Mount Sinai is ranked No. 11 nationwide in NIH funding.
Newsweek's 'The World's Best Smart Hospitals' ranks The Mount Sinai Hospital as No. 1 in New York and in the top five globally.

Equal Opportunity

The Mount Sinai Health System is an equal opportunity employer, complying with all applicable federal civil rights laws.
They do not discriminate, exclude, or treat individuals differently based on race, color, national origin, age, religion, disability, sex, sexual orientation, gender, veteran status, or any other characteristic protected by law.
They are committed to fostering an environment where all faculty, staff, students, trainees, patients, visitors, and the communities served feel respected and supported.
Their goal is to create a healthcare and learning institution that actively works to remove barriers, address challenges, and promote fairness in all aspects of the organization.