Senior CRA, Global Pharma FSP – Remote Romania

Syneos Health, Inc.; Ro; Remote; EUR 60,000 - 90,000; Full time

Job summary

Syneos Health is seeking a Sr CRA - FSP with homebased role based in Romania to support global pharma projects. You will perform site qualification, initiation, monitoring and close-out visits, ensuring ICH-GCP compliance and accurate data capture across sites, remotely or on-site as required.

The role requires strong GCP knowledge, excellent communication skills, and the ability to manage travel up to 75%.

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 and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
• Verifies informed consent process and protects confidentiality; assesses safety and data integrity factors at investigator sites.
• Per CMP/SMP: assesses site processes, conducts source document review, ensures CRF data accuracy and timeliness; drives query resolution.
• May perform IP inventory, reconciliation and storage/labeling checks per protocol.
• Reconciles ISF with TMF and ensures archiving per local regulations.
• Documents activities and supports subject recruitment and data tracking; maintains project records.

Skills

Bachelor’s degree or RN

ICH-GCP knowledge

Good computer skills

Excellent communication skills

Willingness to travel

Education

Bachelor’s degree or RN in a related field

Job description

Syneos Health is seeking a Sr CRA - FSP with homebased role based in Romania to support global pharma projects. You will perform site qualification, initiation, monitoring and close-out visits, ensuring ICH-GCP compliance and accurate data capture across sites, remotely or on-site as required.

The role requires strong GCP knowledge, excellent communication skills, and the ability to manage travel up to 75%.