CRA II / Senior CRA – Remote (Lithuania) – Single Sponsor
syneoshealth · LTU-Remote
Darbo aprašymas
About the role
Syneos Health is seeking an experienced Clinical Research Associate (CRA II) or Senior CRA to support a single‑sponsor, Functional Service Provider (FSP) study. This home‑based position in Lithuania will involve remote and on‑site monitoring activities across the study lifecycle.
Key responsibilities
- Perform site qualification, initiation, interim monitoring, management and close‑out visits, ensuring compliance with regulatory, ICH‑GCP and protocol requirements.
- Conduct source document review, verify data entry in CRFs, and resolve queries both remotely and on‑site.
- Manage investigational product inventory, reconciliation, storage, and dispensing according to protocol.
- Maintain Investigator Site Files, reconcile with Trial Master Files, and support audit readiness.
- Provide training, mentorship, and supervision to junior CRA staff as needed.
- Participate in investigator meetings, sponsor interactions, and global monitoring team meetings.
Required profile
- Bachelor’s degree or RN in a related field, or equivalent experience.
- Strong knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements.
- Excellent communication, presentation and interpersonal skills.
- Willingness to travel up to 75% of the time, including on‑site visits.
Required skills
- Good Clinical Practice (GCP) and ICH‑GCP compliance.
- Experience with electronic data capture (EDC) systems.
- Source document review and query resolution techniques.
- Investigational product (IP) handling and inventory management.
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Baigia galioti 1 mėnuo nuo dabar
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syneoshealth
LTU-Remote
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