Program Manager Clinical Research

Montefiore Hudson Valley Collaborative; New York (NY); On-site; USD 84,000 - 105,000; Full time

Job summary

Montefiore Hudson Valley Collaborative is looking for a dedicated Clinical Research Program Manager in Bronx, New York. This full-time position involves overseeing compliance and quality assurance for cancer clinical trials. The ideal candidate will have a strong background in regulatory standards and project management to ensure high-quality, compliant research.

Candidates must possess a Bachelor's degree and a minimum of 5 years of experience in clinical research, preferably with CCRP/CCRC certification. Exceptional communication and leadership skills are essential for success.

Qualifications

• 5 years of work experience required.
• Minimum of 3 years of experience in clinical research.
• CCRP/CCRC Certification preferred.

Responsibilities

• Provide compliance and quality assurance reviews.
• Monitor ongoing clinical research activities.
• Develop eligibility review processes for clinical studies.

Skills

Compliance and quality assurance

Regulatory standards

Analytical skills

Project management

Effective communication

Education

Bachelor's degree

Master's degree (preferred)

Job description

## Program Manager Clinical ResearchApplylocations: 111 East 210th Streettime type: Full timeposted on: Posted Todayjob requisition id: JR230073**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-$105,000.00The **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.**The Clinical Research Program Manager 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 communicationMontefiore 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.