Sr CRA
Remote · Germany
Job Summary
Sr CRA responsibilities include site qualification, initiation, interim monitoring, site management and close-out visits (on-site or remote); verify informed consent; ensure regulatory and GCP/GPP adherence; perform source document review and CRF data verification; apply IP inventory controls and archiving for ISF/TMF; drive query resolution and ensure audit readiness; support site recruitment, retention and awareness strategies; collaborate with Sponsor teams and provide training/mentorship as needed. Qualifications require a Bachelor’s degree or RN in a related field, knowledge of GCP/ICH and strong communication skills. Roles may involve significant travel and may be titled Sr. Site Management Associate I for Real World Late Phase assignments.
Required Qualifications
- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Excellent communication, presentation and interpersonal skills
- Basic level of critical thinking skills; ability to travel up to 75%
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