Position Overview
- Location Type: Remote
- Employment Type: Full Time
- Salary: Not specified
The CRA is an important member of the Alira Health Clinical team. The CRA is highly motivated and functions independently to conduct site monitoring responsibilities for clinical trials; as well as providing oversight, leadership, and guidance in the management and execution of clinical trials to ensure compliance and quality. The CRA works closely with Lead CRAs, Sr CRAs, in-house CRAs, Associate Director of Clinical Monitoring and Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues.
Responsibilities
- Provides guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements.
- Reviews monitoring visit reports, conducts co-monitoring and evaluation visits as needed.
- Ensures appropriate and timely investigator site visits.
- Coordinates with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related issues.
- Assists in development of study-specific Monitoring Plans and training presentations as required.
- Assists in set up/collection of site specific ethics documents and site contract negotiation as required.
- Provides monthly billing information to finance team as required.
- For monitoring stand-alone projects, manages study budget and acts as referent for the sponsor.
- Performs qualification, initiation, interim, and close-out visits both remotely and onsite, ensuring proper documentation of monitoring visits.
- Prepares consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status.
- Ensures integrity of CRF data through meticulous and thorough source document review and verification.
- Performs quality control and verification of documents collected at sites for eTMF/TMF.
- Conducts investigational product accountability.
- Reviews site regulatory binder for required documents.
- Maintains regular contact with study sites to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to sponsor requests.
- Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company/Sponsor SOPs.
- Participates in internal, client/sponsor, scientific, and other meetings as required.
- Facilitates adverse event reporting and ensures the reconciliation of SAE reports with source documentation and CRFs.
- Works closely with in-house CRAs/CTC and data management to resolve queries on discrepant data.
Requirements
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Company Information
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