Program Manager Clinical Research

3000 Montefiore Medical Center; United States; On-site; USD 84,000 - 105,000; Full time

Job summary

Montefiore Medical Center in Bronx, NY seeks a Clinical Research Program Manager, Monitor, to perform compliance and QA reviews for the Cancer Clinical Trials Office under the Director of Quality Assurance. The role oversees monitoring activities, patient reviews, and regulatory assessments for investigator-initiated trials.

The ideal candidate has a Bachelor’s degree (master’s preferred), 5 years of work experience, and at least 3 years in clinical research, with CCRP/CCRC preferred and FDA

Qualifications

• Bachelor's degree required; master's preferred.
• Minimum 5 years of work experience.
• Minimum 3 years in clinical research.
• CCRP/CCRC certification preferred.
• Experience with internal audits or FDA inspection prep.
• Knowledge of FDA, OHRP, GCP and related regulatory standards.

Responsibilities

• Provide compliance and quality assurance reviews for Montefiore Einstein Cancer Clinical Trials Office.
• Monitor patient case reviews, pharmacy reviews, and regulatory reviews for investigator-initiated trials.
• Develop and support eligibility review processes for patients enrolled in cancer clinical studies.

Skills

Quality assurance

Regulatory knowledge

CAPA

Project management

FDA inspections

Education

Bachelor's degree

Master's degree preferred

Job description

City/State: Bronx, New York | Grant Funded: Yes | Department: Cancer Clinical Trials Office | Work Shift: Day | Work Days: MON-FRI | Scheduled Hours: 9 AM-5:30 PM | Scheduled Daily Hours: 7.5 HOURS | Pay Range: $84,000.00-$105,000.00

The Clinical Research Program Manager, under the supervision of the Director of Quality Assurance, will provide compliance and quality assurance reviews for the Montefiore Einstein Cancer Clinical Trials Office.The Clinical Research Program Manager- Monitor will be responsible for all ongoing monitoring activities – patient case reviews, pharmacy reviews, regulatory reviews for Montefiore Einstein Cancer Center Investigator Initiated Trials (trials where MECC clinicians are the Sponsor Investigators/IND Holder). The CRM will provide routine reviews and determine if there are compliance concerns that warrant a formal of the trials. The duties of this position must be executed in accordance with Good Clinical Practice (GCP) guidelines, Standard Operating Procedures (SOPs), the Montefiore Einstein Cancer Center Data and Safety Monitoring Plan (DSMP), and any other applicable regulatory requirements.

Key Responsibilities

• Work under the direction of the Director, Quality Assurance and will provide constant feedback on findings and evaluation of instituted Corrective and Preventative Action Plans (CAPA).
• Serve as the Administrator for the MECC Data and Safety Monitoring Committee.
• Work with the Director, Quality Assurance to develop and support an eligibility review process for all patients enrolled on cancer clinical studies.

Requirements

• Bachelor's degree required, master's degree preferred.
• 5 years of work experience required.
• Minimum of 3 years of experience in clinical research.
• CCRP/CCRC Certification preferred.
• Prior experience with internal audits and/or FDA inspection preparations.
• Demonstrated knowledge proficiency of and adherence to federal (FDA, OHRP, GCP, etc.), state, and other regulatory standards, requirements, and guidelines related to clinical research.
• Strong working knowledge of ongoing monitoring techniques (including criteria development and trending).
• Strong working knowledge of quality management principles, tools, and risk management techniques.
• Analytical and critical thinking skills to recognize trends.
• Demonstrated ability to manage projects: ability to prioritize, identify barriers and meet deadlines.
• Ability to prioritize, organize, plan, and implement services as well as handle multiple projects/problems simultaneously.
• Demonstrated communication, leadership, and team building skills: evidence of this should include dealing well with people, effective problem solving, appropriately confronting issues, motivating others as individuals and as groups, planning, organizing and directing the activities of others.
• Demonstrated skill in working with minimal supervision.
• Effective written and verbal communication.

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.

Since its inception in 1884, Montefiore’s mission has been to heal, to teach, to discover and advance the health of the communities we serve. Montefiore's state-of-the-art facilities include the internationally-recognized Children’s Hospital at Montefiore and our Notable Centers of Excellence - Montefiore Einstein Center for Cancer Care, Montefiore Einstein Center for Heart and Vascular Care, Montefiore Einstein Center for Transplantation. Combined with a growing number of locations for primary and specialty care throughout the Bronx and Westchester County, Montefiore is the ideal organization to apply and hone your expertise.

An assortment of insurance products and discount programs through Voluntary Benefits. Check out our comprehensive benefits available to you when you join our outstanding team!

To heal, to teach, to discover and to advance the health of the communities we serve. To be a premier academic medical center that transforms health and enriches lives.