Clinical Research Coordinator I

Montefiore Health System • New York, NY

18d • $53,040 - $66,300 • Onsite

About The Position

The Clinical Research Coordinator I will oversee multiple clinical trials, investigator-initiated studies, and quality improvement projects within the department of Neurology. This role serves as a point person for patients, their family members, and the clinical study team. The position involves working with various departments across the hospital and forging new partnerships to ensure the completion of trial-related activities. The clinical research coordinator I 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, NIH, and the FDA. Under general supervision, duties will include directing the seamless flow of daily trial-related activities, recruitment, and clinical assessments of study subjects. This role also involves directing strict adherence to study protocols and sponsor, FDA, and other regulatory authority requirements. The coordinator will design and implement workflows for clinical trials, including reminders and updates to the clinical team, and coordinate team members to complete both clinical and non-clinical assessments per protocol. This includes developing workflows for patient care, such as assigning secretaries to schedule patients, developing workflows with ancillary departments (e.g., radiology, advanced imaging, pathology, pharmacy), and assigning appropriate clinical team members (e.g., doctors) to complete clinical tasks like reviewing adverse events, or assigning non-clinical team members to complete non-clinical tasks such as administering questionnaires. The role also includes executing IRB submissions (event reporting, study status changes, etc.), executing patient billing in multiple databases including the patient's electronic medical record, and developing action plans for ensuring all study tasks are completed as required per the protocol, including developing subsequent corrective action plans if errors are made. Additionally, the coordinator will lead and support manuscript preparation, including drafting abstracts and manuscripts, coordinating co-author input, and preparing study data for presentation and submission to peer-reviewed journals. The Clinical Research Coordinator I will be trained to be highly specialized in clinical trials assigned to them and is expected to manage clinical trial projects independently after sufficient training is completed.

Requirements

• BS Required
• OHS Annual Assessment Required
• OHS Fit Test Required
• CITI Good Clinical Practice Certification, CITI Research with Biomedical Drugs and Devices Certification, CITI Dangerous Goods and Biospecimen Handling Certification.
• Experience in clinical research, clinical trials and/or any medical-related profession.

Nice To Haves

• The position will be primarily based at the Moses campus, with occasional travel to other Montefiore locations as needed.

Responsibilities

• Escalates issues related to clinical trial conduct to PI and senior research staff.
• Assigns training to the PI and other research team members for protocol amendments and any other study-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.
• Develops and executes multifaceted recruitment strategies by blending creative patient outreach with technical workflow integration and cross-departmental partnerships to optimize subject identification and enrollment.
• Oversees the quality of data provided to sponsor, escalates quality issues to the site manager.
• Maintains accurate records of study participants while safeguarding the confidentiality of subjects, as necessary.
• Maintains essential documents per FDA, Regulatory bodies, and sponsor requirements in the Regulatory Binder. This includes preparation of essential documents for the assigned clinical study.
• Provides ready access to patient binders and regulatory binders to the PI, Sponsor and/or Regulatory Authorities for assigned clinical trials.
• Coordinates and carries out monitoring visits and audits for assigned clinical trial.
• Collaborates with the appropriate institutional review board to ensure approval of the clinical trial (renewal), approval of study documents (renewal, modification, notification), and personnel.
• Assists management with the collection of updated essential documents and certifications for site personnel and sends these to the sponsor as requested.
• Participates in Site Initiation Visit.
• 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 dependent on the nature of the clinical trial.

Benefits

• An assortment of insurance products and discount programs through Voluntary Benefits.
• Comprehensive benefits available to you when you join our outstanding team!

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level