City/State:
Bronx, New York Grant Funded:
Yes Department:
Neuro - Research/Clinical Work Shift:
Day Work Days:
MON-FRI Scheduled Hours:
8:30 AM-5 PM Scheduled Daily Hours:
7.5 HOURS Pay Range:
$53,040.00-$66,300.00
Clinical Research Coordinator I will oversee multiple clinical trials, investigator-initiated studies, and quality improvement projects within the Department of Neurology and support the Department's programs, 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 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 and the FDA.
Under general supervision duties will include:
• Directing seamless flow of daily trial-related activities, recruitment and clinical assessments of the study subjects
• Directing strict adherence to the study protocols, as well as sponsor, FDA and other regulatory authority requirements.
• Designs and implements workflows for clinical trials, including reminders/updates to the clinical team
• Coordinating team members to complete both clinical and non-clinical assessments per protocol. This includes developing workflow for patient care such as assigning secretaries to schedule patients, developing workflow with ancillary departments (such as radiology, advanced imaging, pathology, pharmacy), and assigning appropriate clinical team members such as doctors to complete clinical tasks such as reviewing adverse events versus assigning non-clinical team members to complete non-clinical tasks such as administering questionnaires to a patient.
• Executing IRB submissions (event reporting, study status change etc.)
• Executing patient billing in multiple databases including the patient's electronic medical record.
• Developing action plans for ensuring all study tasks are completed as required per the protocol and developing subsequent corrective action plans if any errors are made.
• Coordinating appointments, procedures, and related services, and supporting financial activities.
The Clinical Research Coordinator I will be trained to be highly specialized in clinical trials assigned to them. The Clinical Research Coordinator I is expected to be able to manage clinical trial projects independently after sufficient training is completed.
Essential Functions
• 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.
• Schedules and coordinates appointments, procedures, and related services; records documentation, communications, and related information in the electronic medical record and other systems.
• Serves as a point of contact for patients, providers, sponsors, vendors, and other internal and external parties.
• 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,…