Sr. Clinical Research Associate (Poland)
HybridWarsaw, Mazovia, Poland
Job Summary
Independently conduct onsite and remote site monitoring, qualification, and close-out visits while ensuring data consistency with source documents and resolving queries. Coordinate clinical supply shipments, manage Investigator meetings, and oversee TMF and ISF accuracy for protocol and regulatory compliance. Act as the primary liaison between Alimentiv and investigative sites, providing guidance to CRA I and II, and support site recruitment and setup activities. Participate in routine study progress meetings, audits, and inspections as required. Home-based position with up to 40-60% travel; requires fluent English, ICH-GCP knowledge, and proficiency in EDC and eTMF systems.
Required Qualifications
- 4 - 6 years of related experience
- (Honors) Bachelor's degree
- Fluent in written and verbal English
- Thorough knowledge of ICH-GCP and local regulatory requirements
- Holder of a valid driver's license
- Ability to travel up to 40-60%, depending on project assignment and geographic location of sites
- Great communication and organizational skills
- Detailed orientation
- Sense of urgency
Desired Qualifications
- 7 – 9 years of related experience
- Master's degree
- Health Sciences, Life Sciences, Pharmacy or Nursing degree
- Sr.CRA and/or ACRP Certification/Designation
- Experience with Phase I–IV clinical trials
- Proficient in using EDC systems (e.g., Medidata Rave, Oracle InForm), IRT, eTMF, CTMS, and Microsoft Office Suite
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