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Manager Clinical Research Informatics Jobs in Indiana

BioTalent

We are seeking an experienced Senior Clinical Research Associate (CRA) to independently manage and monitor clinical trial sites throughout the full study lifecycle, from start-up through close-out.

IU Health

Clinical Informaticist

Muncie, IN · On-site

Manager - Information Services Direct reports: None Shift: Full time, Monday - Friday; hybrid ... This role supports clinical informatics operations across assigned sites, including: * Serving as a ...

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Senior Clinical Research Associate

On-site

BioTalent
See more jobs at BioTalentexternal

Other

Posted 15 days ago

Job description


We are seeking an experienced Senior Clinical Research Associate (CRA) to independently manage and monitor clinical trial sites throughout the full study lifecycle, from start-up through close-out. This is a highly autonomous, field-based role requiring an experienced monitor who can take ownership of site activities with minimal supervision while ensuring the highest standards of compliance, data quality, and site performance.


Key Responsibilities

Independently conduct:

  • Site Qualification Visits (SQVs)
  • Site Initiation Visits (SIVs)
  • Interim Monitoring Visits (IMVs)
  • Close-Out Visits (COVs)
  • Serve as the primary point of contact for assigned clinical trial sites.
  • Ensure compliance with study protocols, ICH-GCP, FDA regulations, and applicable SOPs.
  • Perform source data verification, resolve site queries, and maintain data integrity and quality.
  • Manage Investigator Site Files (ISF) and support Trial Master File (TMF) documentation to maintain inspection readiness.
  • Conduct investigational product accountability and reconciliation activities.
  • Provide ongoing site training, support, and guidance throughout the study lifecycle.
  • Complete monitoring reports, follow-up letters, and visit documentation within required timelines.
  • Identify, escalate, and support resolution of site issues and compliance risks.


Requirements

  • Bachelor's degree in Life Sciences or a related scientific discipline.
  • Minimum 5 years of CRA monitoring experience within clinical research.
  • Proven experience independently managing sites across the full clinical trial lifecycle.
  • Strong knowledge of:
  • ICH-GCP
  • FDA regulations
  • Clinical trial operations
  • eCRF and electronic data capture systems
  • Demonstrated ability to manage multiple sites and priorities simultaneously.


Contract Details

  • Valid driver's licence required.
  • Up to 100% travel required, including air and ground travel.

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