Clinical Research Coordinator II

Introduction To heal, to teach, to discover and to advance the health of the communities we serve. For more about the “Montefiore Difference” – who we are at Montefiore and all that we have to offer our associates, please click here. Overview City/State: Bronx, New York Grant Funded: Yes Department: Urology - Research Work Shift: Day Work Days: MON-FR Scheduled Hours: 8:30 AM-5 PM Scheduled Daily Hours: 7.5 HOURS Pay Range: $52,000.00-$65,000.00 Job Summary Clinical Research Coordinator II will oversee multiple clinical trials, serving as a point person for patients, their family members and the clinical study team. The position consists of working with various departments across the hospital, including forging new partnerships with departments to ensure completion of trial‑related activities. The coordinator will direct participants and study team members to adhere to the study protocol and rules and regulations as governed by regulatory bodies including Institutional Review Boards and the FDA. oversee daily operations of clinical trials, recruitment, and clinical assessments of study subjects direct strict adherence to study protocols, sponsor, FDA and other regulatory authority requirements develop workflows for clinical trial, including reminders/updates to the clinical team delegate team members to complete both clinical and non‑clinical assessments per protocol, including coordinating patient care, radiology, imaging, pathology, pharmacy, and clinical staff assist with training of new team members via didactic and shadowing routes oversee the work of less experienced clinical research staff execute IRB submissions, finance/budget review and participant compensation The Clinical Research Coordinator II is expected to leverage exceptional working knowledge of good clinical practice (GCP) and ICH regulatory instructions for their trials. They should manage a higher number of clinical trial projects and handle more complex trials, such as early feasibility trials. Responsibilities Assist with the planning and project setup of new trials and financial closeout of existing trials. Assist with quality assessment across trials. Escalate issues related to clinical trial conduct to PI and senior research staff. Assign training to the PI and other research team members for protocol amendments and other required training. Screens and consents patients and ensures the scheduling and completion of assessments for ongoing study visits as dictated by the protocol. Collects required data and imaging and ensures data entry into EDCs/Databases and image upload to imaging portals. Mentors, trains, and educates less experienced research coordinators and technicians regarding trial conduct. Investigates opportunities for subject recruitment, screening, and enrollment. Oversees data collection, storage, and entry from less experienced staff. Oversees the quality of data provided to sponsor, escalates quality issues to the site manager, and assists in identifying opportunities to improve training, execution, and quality control across the clinical team. Maintains accurate records of study participants while safeguarding confidentiality. Maintains essential documents per FDA, regulatory bodies, and sponsor requirements in the regulatory binder, including preparation and review of essential documents. Provides ready access to patient binders and regulatory binders to the PI, sponsor and/or regulatory authorities for assigned clinical trials. Prepares and carries out monitoring visits and audits for assigned clinical trials; assists and supervises site monitoring visit preparation by junior staff. Collaborates with the appropriate institutional review board to ensure approval of the clinical trial (initial and renewal), study documents, and personnel. Assists management with collection of updated essential documents and certifications for site personnel; sends these to sponsor as requested. Participates in Site Initiation Visit, assists with feasibility questionnaire and site qualification visits. Processes, packages, stores and ships clinical specimens as required by the protocol. Responsible for device accountability, ordering and storage of investigational products and/or lab kits. Performs other duties as assigned depending on the nature of the clinical trial. Qualifications BS Required Experience in Clinical Trial Management Required 1-3 years experience (minimum 2 years) Required CITI Good Clinical Practice Certification CITI Research with Biomedical Drugs and Devices Certification CITI Dangerous Goods and Biospecimen Handling Certification 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. Requirements BS Required Experience in Clinical Trial Management Required 1-3 years experience (minimum 2 years) Required CITI Good Clinical Practice Certification CITI Research with Biomedical Drugs and Devices Certification CITI Dangerous Goods and Biospecimen Handling Certification #J-18808-Ljbffr