Clinical Research Associate

IUVO BIOSCIENCE OPERATIONS, LLC

Yonkers, NYFull-timePosted Apr 30, 2026

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Qualifications

  • •Timely completion, review, and understanding of iuvo SOPs, work instructions and guidelines, and any sponsor-specific requirements
  • •Ability to work across multiple trials as needed

Responsibilities

  • •The Clinical Research Associate (CRA) is responsible for the monitoring of clinical research activities at research sites that are actively conducting clinical trials
  • •Perform site qualification, initiation, interim monitoring, and close-out visits per study-specific plans/requirements
  • •Review for regulatory and protocol compliance
  • •Review and verify informed consent forms and informed consent process
  • •Assess PI oversight of study activities
  • •Confirm accuracy and data integrity by reviewing eCRFs/CRFs, site source documents and other sources of study-specific site documents as applicable
  • •Complete timely and comprehensive site visit reports and associated correspondence per the trial-specific Monitoring Plan
  • •Adhere to trial-specific monitoring visit report submission, finalization, and associated correspondence timelines
  • •Identify and report protocol deviations and risks to subject safety/data integrity
  • •Generate queries and work towards query resolution with site personnel
  • •Perform investigational product and/or device, ancillary supplies, and equipment review/accountability as applicable
  • •Evaluate performance of and adherence to study protocol at the site level
  • •Evaluate overall performance of site and site staff, provide recommendations, and elevate issues as needed
  • •Provide initial site training and re‑training as needed
  • •Monitor trial participant recruitment activities and progress
  • •Reconcile and facilitate adverse event and serious adverse event reporting and documentation as needed
  • •Review essential regulatory documents and compare them to study TMF to confirm completeness and accuracy
  • •Verify site study supply inventory is adequate as applicable
  • •Participate in the identification and selection of investigators and sites as applicable
  • •Serve as a liaison and resource for Investigators, Institutions, and Sites, providing support during the conduct of the clinical trial
  • •Attend internal and external team calls to stay informed of current study status and provide feedback/updates as needed
  • •Attend internal and external trial-level, line manager/department-level, and company-level meetings as applicable
  • •Provide In‑House CRA and Site Start‑up and Essential Document Specialist support for assigned sites as needed inclusive of but not limited to:
  • •Data line listing review/data cleaning activities prior to data locks, eTMF document workflow processing and maintenance of regulatory trackers
  • •Complete timely entry of data for assigned sites within trial level electronic tracking system as applicable (e.g., CTMS)
  • •Action Items, Site Visit status, Monitoring Visit Report and site correspondence, and PDs
  • •Maintain timely trial-level calendar updates for monitoring visits, travel, and out of office time, as applicable
  • •Promptly submit time and expense reports within specified electronic system and adhere to trial-level budget requirements
  • •Escalate issues as needed
  • •Maintain a working knowledge of ICH/GCP Guidelines, medical terminology, and relevant FDA regulations
  • •May mentor other internal study‑team members
  • •May assist with development of study manuals, plans, CRFs, and other study‑specific tools/templates
  • •May present at Investigator and other trial‑specific…
  • •30 more items(s)
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