Part‑time Clinical Research Associate (0.5 FTE) – Remote in Lithuania
syneoshealth · LTU-Remote
Darbo aprašymas
About the role
Syneos Health is seeking a part‑time Clinical Research Associate to support site activities for real‑world late‑phase studies. The role is home‑based in Lithuania and involves both remote and on‑site monitoring tasks.
Key responsibilities
- Perform site qualification, initiation, interim monitoring, management and close‑out visits, ensuring compliance with regulatory, ICH‑GCP and Good Pharmacoepidemiology Practice guidelines.
- Review informed consent processes, protect patient confidentiality, and assess safety and data integrity issues.
- Conduct source document reviews, verify CRF data accuracy, and manage query resolution.
- Handle investigational product inventory, reconciliation, storage, and dispensing according to protocol.
- Maintain Investigator Site File accuracy, reconcile with Trial Master File, and support archiving requirements.
- Document activities via letters, reports, and logs; support recruitment, retention and tracking of observations.
- Act as liaison with site personnel, ensure training compliance, and prepare for audits.
- Participate in investigator meetings, global monitoring meetings and training sessions.
Required profile
- Bachelor’s degree or RN in a related field, or equivalent experience.
- Knowledge of Good Clinical Practice, ICH guidelines and relevant regulatory requirements.
- Excellent communication, presentation and interpersonal skills.
- Ability to manage up to 75% travel when required.
Required skills
- Proficiency with electronic data capture systems and related software.
- Strong computer skills and ability to adopt new technologies.
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Paskelbta prieš 6 valandas
Baigia galioti 1 mėnuo nuo dabar
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syneoshealth
LTU-Remote
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