Title: Clinical Research Project Manager

Location: Upper East Side

Org Unit: Cardiac Research

Work Days: Monday-Friday

Exemption Status: Exempt

Salary Range: $92,200.00 - $105,200.00

*As required under NYC Human Rights Law Int 1208-2018 - Salary range for this role when Hired for NYC Offices

Position Summary

The Clinical Research Project Manager supervises the Clinical Research Project Team and oversees all aspects of study coordination and study conduct for multisite investigator-initiated studies with a focus on large, pragmatic clinical trials. This key role will serve as the expert in project operations including study design, study conduct, data management, and quality assurance.

Job Responsibilities

• Supervise the Clinical Research Project Team working on disease-related project portfolio.

• Serves as point person to manage the communications and reporting to the funding agency.

• Strategizes with the WCM Principal Investigator (PI) to ensure target recruitment goals are achieved. Develop subject recruitment assets and community outreach and engagement initiatives.

• Aligns w/ key stakeholders, both internal & external to manage all study coordination & conduct activities for multisite investigator-initiated studies in accordance w/ relevant regulations, Standard Operating Procedures (SOP), & study specific procedures.

• Serves as the primary contact for external subsites on all project related operational matters.

• Collaborates with WCM PI on project design and development of study protocol and informed consent form (ICF).

• Completes all WCM regulatory submissions including Protocol Review and Monitoring Committee (PRMC), Institutional Review Board (IRB), Data Safety Monitoring Committee (DSMC), and other regulatory agencies as required.

• Coordinates with Clinical Research Subsite Navigators to ensure timely dissemination of new and revised project documents to participating subsites.

• Creates the electronic data capture (EDC) system in collaboration with the developers on protocol-specific database design. Ensures the user interface is intuitive for study team use.

• Generates subsite data completion metrics for distribution to subsite PIs and study teams.

• Develops and implements a project-specific monitoring plan. Performs remote monitoring visits to review data timeliness and accuracy.

• Issues queries for missing data elements or those requiring follow-up. Ensures timely resolution of pending data entry and queries.

• Plans subsite Site Initiation Visits (SIV). Develops presentations, training, and educational materials to ensure successful subsite start up. Provides ongoing training and subsite study team support throughout the course of the project.

• Prepares and presents study metrics, progress, and long-term goals at Steering Committee meetings. Leads project-specific study coordinator meetings.

• Provides ongoing updates and reporting to subsite study teams, WCM PI and internal collaborators. Streamlines and facilitates communications with subsites.

• Performs other related duties as assigned

Education

• Bachelor's Degree

Experience

Approximately 5 or more years of related research experience in clinical trial management.

Knowledge, Skills and Abilities

• Knowledge of FDA regulations, IRB requirements, Good Clinical Practice, and clinical research databases.

Licenses and Certifications

Working Conditions/Physical Demands

Weill Cornell Medicine is a comprehensive academic medical center that is committed to excellence in patient care, scientific discovery, and the education of future physicians and scientists in New York City and around the world. Our doctors and scientists - faculty from Weill Cornell Medical College, Weill Cornell Graduate School of Medical Sciences, and the Weill Cornell Physician Organization - are engaged in world-class clinical care and cutting-edge research that connect patients to the latest treatment innovations and prevention strategies. Located in the heart of the Upper East Side's scientific corridor, Weill Cornell Medicine's powerful network of collaborators extends to its parent university Cornell University; to Qatar, where an international campus offers a U.S. medical degree; and to programs in Tanzania, Haiti, Brazil, Austria and Turkey. Our medical practices serve communities throughout New York City, and our faculty provide comprehensive care at NewYork-Presbyterian Hospital/Weill Cornell Medical Center, NewYork-Presbyterian/Lower Manhattan Hospital, NewYork-Presbyterian Hospital/Brooklyn Methodist Hospital, NewYork-Presbyterian Hospital/Westchester Behavioral Health Center, and NewYork-Presbyterian/Queens. At Weill Cornell Medicine, we work together to treat each individual, not just their conditions or illnesses, as we strive to deliver the finest possible care for our patients - the center of everything we do. Weill Cornell Medicine is an Equal Employment Opportunity Employer. Weill Cornell Medicine provides equal employment opportunities to all qualified applicants without regard to race, sex, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, or genetic information.