Program Manager Clinical Research

Montefiore Mount Vernon; New York (NY); Vor Ort; USD 84.000 - 105.000; Vollzeit

Zusammenfassung

Montefiore Medical Center is seeking a Clinical Research Program Manager to provide compliance and QA reviews for the Cancer Clinical Trials Office. The role oversees monitoring activities (patient cases, pharmacy, regulatory reviews) to ensure adherence to GCP and DSMP, with CAPA and committee administration responsibilities.

The candidate will work under the Director of Quality Assurance, ensuring FDA and OHRP regulatory alignment and efficient, compliant trial operations across

Qualifikationen

• Bachelor’s degree required; master’s degree preferred.
• Minimum of 3 years of experience in clinical research.
• 5 years of work experience required.
• CCRP/CCRC Certification preferred.
• Prior experience with internal audits and/or FDA inspection preparations.
• Knowledge of federal (FDA, OHRP, GCP) and other regulatory standards for clinical research.
• Strong knowledge of ongoing monitoring techniques and CAPA.
• Ability to manage multiple projects and meet deadlines.
• Excellent written and verbal communication.

Aufgaben

• Provide compliance and quality assurance reviews for Montefiore Einstein Cancer Clinical Trials Office.
• Perform ongoing monitoring: patient case reviews, pharmacy reviews, regulatory reviews.
• Determine if compliance concerns warrant formal action.
• Serve as Administrator for MECC Data and Safety Monitoring Committee.
• Develop and support eligibility review processes for patients enrolled on cancer studies.

Kenntnisse

Quality assurance

Regulatory knowledge

Clinical research

Project management

CAPA

FDA inspections

GCP/SOPs

Data and safety monitoring

Ausbildung

Bachelor’s degree

Master’s degree

CCRP/CCRC Certification

Jobbeschreibung

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 ResearchProgramManager, 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 ResearchProgramManager- 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.

The Clinical ResearchProgramManager will:

• 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.