Montefiore Einstein Technology · 1 month ago
Program Manager Clinical Research
111 East 210th Street
Full-time
Onsite
Mid, Senior Level
$80K/yr - $100K/yr
5+ years expMontefiore Einstein Technology is seeking a Clinical Research Program Manager to oversee compliance and quality assurance for the Cancer Clinical Trials Office. This role involves monitoring clinical trials, conducting reviews, and ensuring adherence to regulatory standards and guidelines.
Information Technology & Services
Responsibilities
Monitor, under the supervision of the Director of Quality Assurance, will provide compliance and quality assurance reviews for the Montefiore Einstein Cancer Clinical Trials Office
Responsible for all ongoing monitoring activities -patient case reviews, pharmacy reviews, regulatory reviews for Montefiore Einstein Cancer Center Investigator Initiated Trials
Provide routine reviews and determine if there are compliance concerns that warrant a formal of the trials
Execute duties 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
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
Qualification
Required
Bachelor's degree requires
5 years of work experience required
Minimum of 3 years of experience in clinical research
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
Preferred
Master's degree preferred
CCRP/CCRC Certification preferred
Company
Montefiore Einstein Technology
Montefiore Einstein Technology began a cultural transition from a provider of IT services and support to an integral component of Montefiore Medical Center/Systems and its affiliates located in the Bronx, Westchester, and Rockland Counties, with our focus on Customer Service and meeting Montefiore’s Health Systems Mission, Vision, and Values.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase