Senior Clinical Research Associate (CRA) - Romania

About the role

iQVIA is looking for a Senior CRA based in Bucharest to perform site monitoring and site management work. The goal is to make sure sites carry out the study(s) and report study data as required by the protocol, applicable regulations and guidelines, and sponsor requirements.

Key responsibilities

• Carry out site monitoring visits (selection, initiation, monitoring and close-out) in line with the contracted scope of work and Good Clinical Practice.
• Work with sites to adapt, drive and track the subject recruitment plan so that project needs are met.
• Administer protocol and related study training to assigned sites and keep regular contact to manage ongoing expectations and issues.
• Evaluate the quality and integrity of site practices, escalate quality issues as appropriate, and track regulatory submissions, recruitment, CRF completion 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 regulations.
• Create and maintain documentation such as visit reports, follow-up letters and action plans.
• Liaise with study team members; may also support site recruitment planning and site financial management and invoice retrieval where applicable.

Required profile

• Bachelor's degree in a scientific discipline or health care preferred; equivalent education, training and experience may be accepted.
• At least 2 years of on-site monitoring experience.
• Good knowledge of clinical research regulatory requirements, including GCP and ICH guidelines.
• Good therapeutic and protocol knowledge provided through company training.
• Written and verbal communication skills, including a good command of English.

Required skills

• Proficiency in Microsoft Word, Excel and PowerPoint, and use of a laptop, iPhone and iPad where applicable.
• Organizational, problem-solving, time and financial management skills.
• Ability to build effective working relationships with coworkers, managers and clients.