Remote CRA II – Site Monitoring & Management

Syneos Health, Inc.; Poland; Remote; PLN 90,000 - 150,000; Full time

Job summary

Syneos Health, Inc. in a remote Poland location is seeking a CRA II/SMA II to monitor and manage clinical sites across trials. You will lead monitoring visits, ensure regulatory compliance, manage IP inventory, and collaborate with global teams to maintain data integrity.

The role requires up to 75% travel, strong knowledge of ICH/GCP, and the ability to work across cross-functional teams in a dynamic environment.

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
• Must demonstrate good computer skills and be able to embrace new technologies
• Excellent communication, presentation and interpersonal skills
• Ability to manage required travel of up to 75% on a regular basis

Responsibilities

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.
• Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records.
• May perform investigational product (IP) inventory, reconciliation and reviews storage and security.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness.

Skills

Communication skills

GCP knowledge

Computer skills

Regulatory knowledge

Education

Bachelor’s degree or RN in a related field

Job description

Syneos Health, Inc. in a remote Poland location is seeking a CRA II/SMA II to monitor and manage clinical sites across trials. You will lead monitoring visits, ensure regulatory compliance, manage IP inventory, and collaborate with global teams to maintain data integrity.

The role requires up to 75% travel, strong knowledge of ICH/GCP, and the ability to work across cross-functional teams in a dynamic environment.