Montefiore Einstein

Hospital and health care provider

Clinical Research Program Manager

Clinical Research OperationsConfirmed live in the last 24 hours

Full-timeBronx, NY, USA$84k - $105kIn-person

About the Job

Requirements

A bachelor's degree is required.
At least 5 years of work experience is required.
At least 3 years of clinical research experience is required.
Prior experience with internal audits and/or FDA inspection preparations is required.
Demonstrated knowledge of and adherence to federal (FDA, OHRP, GCP, etc.), state, and other regulatory standards, requirements, and guidelines related to clinical research.
Working knowledge of ongoing monitoring techniques, including criteria development and trending.
Working knowledge of quality management principles, tools, and risk management techniques.
Analytical and critical thinking skills to recognize trends.
Ability to manage projects by prioritizing, identifying barriers, and meeting deadlines.
Ability to prioritize, organize, plan, and implement services, and handle multiple projects and problems simultaneously.
Communication, leadership, and team-building skills, including effective problem solving, appropriately confronting issues, motivating individuals and groups, and planning, organizing, and directing others' activities.
Ability to work with minimal supervision.
Effective written and verbal communication.

Responsibilities

Provide compliance and quality assurance reviews for the Montefiore Einstein Cancer Clinical Trials Office.
Conduct ongoing monitoring activities, including patient case reviews, pharmacy reviews, and regulatory reviews for Montefiore Einstein Cancer Center investigator-initiated trials where clinicians are Sponsor Investigators or IND holders.
Provide routine reviews and determine whether compliance concerns warrant formal review of the trials.
Execute duties in accordance with Good Clinical Practice guidelines, Standard Operating Procedures, the Montefiore Einstein Cancer Center Data and Safety Monitoring Plan, and other applicable regulatory requirements.
Work under the Director of Quality Assurance and provide ongoing feedback on findings and evaluations of instituted Corrective and Preventive Action Plans.
Serve as the administrator for the MECC Data and Safety Monitoring Committee.
Work with the Director of Quality Assurance to develop and support an eligibility review process for all patients enrolled in cancer clinical studies.

Desired Qualifications

A master's degree is preferred.
CCRP or CCRC certification is preferred.

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

TheClinical 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 ResearchProgramManagerwill:

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.

About the Company

Montefiore Einstein

Hospital and health care provider

Montefiore Einstein is a major hospital-and-healthcare network in the Bronx that provides medical care through its hospital and outpatient facilities. It combines clinical services with education and research through its affiliation with the Albert Einstein College of Medicine, offering inpatient and outpatient care, diagnostics, specialty treatments, and community health programs. Its care model centers on teams of doctors, nurses, and other clinicians using integrated systems to diagnose, treat, and manage patients. The partnership with Einstein differentiates it by linking patient care with medical teaching and research, enabling clinical trials and innovations to flow from the lab to the bedside. The goal is to deliver comprehensive, high-quality health care, advance medical knowledge through research and education, and improve health outcomes for the communities it serves.

Company size: 1,001-5,000
Company stage: Not listed
Total funding: $4.9M
Headquarters: New York City, New York
Founded: Not listed

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