must have at least 1 year of independent onsite monitoring
- 2 to 3 protocols
- 8 to 10 sites
- Sites will be local within driving distance or a short direct flight.
- Potential to have sites in neighboring states
- Hybrid of on-site and remote monitoring.
- No on-site metrics.
- Conduct clinical trial site visits including evaluation, initiation, monitoring and close out
- Oversee and report on the conduct of clinical trials at a site level including and on-line site visit reports and updates to electronic management systems
- Proactive site management including :
- Building and maintaining solid and professional relationships with site staff
- Facilitating subject enrolment incorporating recruitment strategies and action plans at site level
- Maintaining site audit / inspection readiness
- Ensuring appropriate safety reporting and use of on-line safety reporting / reviewing systems
- Verification of electronic case report form data against written and electronic source documentation as per study schema / monitoring plan
- Responding to site queries and escalating issues in accordance with processes and timelines
- Conducting IP accountability and reconciliation
- Facilitating implementation of new technologies and systems at clinical sites (Electronic Data Capture, eSAE reporting)
- Maintenance of site study supplies
Cra I/ii
Sites will be local – within driving distance or a short direct flight.Potential to have sites in neighboring states.Hybrid of on-site and remote monitoring.Conduct clinical trial site visits including evaluation, initiation, monitoring and close out.Oversee and report on the conduct of clinical tri...
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