Montefiore Einstein Technology · 2 weeks ago
Clinical Research Coordinator I
3319 Rochambeau Avenue
Full-time
Onsite
New Grad, Entry Level
$53K/yr - $66K/yrMontefiore Einstein Technology is a healthcare organization seeking a Clinical Research Coordinator I to oversee multiple clinical trials. The role involves coordinating activities among various departments, ensuring compliance with protocols, and managing patient interactions and data collection throughout the clinical trial process.
Information Technology & Services
Responsibilities
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
Developing 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
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
Investigates opportunities for Subject recruitment, screening 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
Qualification
Required
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
Company
Montefiore Einstein Technology
Montefiore Einstein Technology began a cultural transition from a provider of IT services and support to an integral component of Montefiore Medical Center/Systems and its affiliates located in the Bronx, Westchester, and Rockland Counties, with our focus on Customer Service and meeting Montefiore’s Health Systems Mission, Vision, and Values.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase