Senior Contract CRA - Remote Clinical Research Expert

Lotus Clinical Research, LLC; Northern (KY); Hybride; USD 110 000 - 140 000; Temps partiel

Résumé du poste

Lotus Clinical Research, LLC is seeking a Contract Senior Clinical Research Associate to oversee site monitoring for multiple clinical trials. You will ensure adherence to protocol, SOPs, FDA regulations, ICH guidelines, and GCP while working remotely with study sites across the US.

The role requires up to 100% travel, independent site evaluation, training on CRF completion, and timely data exchange with the study team.

Qualifications

• Bachelor's degree or equivalent in life sciences; 5+ years CRA field experience.
• Mastery of CRA II responsibilities and regulatory knowledge.
• Valid driver’s license and US work authorization as contractor.

Responsabilités

• Monitor and manage site activities for clinical studies.
• Perform site qualification, initiation, interim monitoring and close-out visits.
• Ensure protocol, SOPs, FDA, ICH-GCP compliance; maintain audit-ready files.
• Communicate with sites and study team; train on CRF completion and data flow.

Connaissances

Clinical monitoring

Regulatory compliance

GCP / ICH knowledge

Site management

Travel up to 100%

Formation

Bachelor's degree in life sciences

Master's degree preferred

Outils

eCRF platforms

Description du poste

Lotus Clinical Research, LLC is seeking a Contract Senior Clinical Research Associate to oversee site monitoring for multiple clinical trials. You will ensure adherence to protocol, SOPs, FDA regulations, ICH guidelines, and GCP while working remotely with study sites across the US.

The role requires up to 100% travel, independent site evaluation, training on CRF completion, and timely data exchange with the study team.