Clinical Research Coordinator I will oversee multiple clinical trials, investigator-initiated studies, and quality improvement projects within the department of Neurology, 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, NIH 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 trial, 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.
-Leads and supports 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. 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
- 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 appropriate institutional review board to ensure approval of the clinical trial (renewal), approval of study documents (renewal, modification, notification) and personnel.
- Assists management with collection of updated essential documents and certifications for site personnel and sends these to 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.
Qualifications
- 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. Preferred
The position will be primarily based at the Moses campus, with occasional travel to other Montefiore locations as needed.