Clinical Research Associate Level 2 (CRA 2) - Biotech

About the role

IQVIA Biotech in the Czech Republic is looking for a CRA 2 to perform monitoring and site management work so that study sites carry out their studies and report data as required by the protocol, regulations, guidelines and sponsor requirements. The role is based in Prague.

Key responsibilities

• Carry out site monitoring visits (selection, initiation, monitoring and close-out) in line with the contracted scope of work and GCP and ICH requirements.
• Work with sites to adapt, drive and track the subject recruitment plan to make it more predictable.
• Administer protocol and study training, keep regular contact with sites and escalate quality issues.
• Track regulatory submissions and approvals, recruitment and enrollment, CRF completion and submission, and data queries.
• Ensure site documents are available for the Trial Master File and that the Investigator's Site File is kept according to GCP and local rules.
• Produce visit reports, follow-up letters and other study documentation, and liaise with the study team.
• If applicable, support the site-level recruitment plan and site financial management and invoice retrieval under the clinical trial agreement.

Required profile

• Bachelor's degree in a scientific discipline or health care; equivalent education, training and experience may be accepted.
• At least 1 year of on-site monitoring experience.
• Good knowledge of GCP and ICH guidelines and good therapeutic and protocol knowledge.
• Written and verbal communication skills, including good command of Czech and English.
• Organizational, problem-solving, time and financial management skills, and ability to build working relationships with colleagues, managers and clients.

Required skills

• Microsoft Word, Excel and PowerPoint
• Laptop, iPhone and iPad (where applicable)