Study Start Up Clinical Research Associate

IQVIA Romania is looking for talented and motivated team member to join our Sponsor dedicated team as Study Start Up Clinical Research Associate. At this position you would be responsible of site preparation and early identification of real site needs and issues and close handover to execution CRA

Your responsibilities will include:

• Performing site selection verification of the elegibility for studies from phase I-IV.
• Acts as the main contact for trial sites during site selection, study start-up and IRB/IEC and HA submission preparation.
• Collects submission-related site-specific documents for all relevant site personnel within agreed timelines (e.g., FD, CV, GCP certificates, DSL, etc.)
• Collaborates with the other team members of start up in timelines and deliverables are met according to country commitments.
• Evaluating the quality and integrity of site practices in accordance with regulatory requirements, i.e., Good Clinical Practice and International Conference on Harmonization guidelines
• Managing progress by tracking regulatory submissions, recruitment, case report form completion, and data query resolutions
• Collaborating with experts at study sites and with client representative

Your Profile

• University degree in scientific discipline or health care
• Experience in Submissions, Site Identification, issue management and risk identification.
• Very good computer skills including MS Office
• Excellent command of Romanian English language. Romania based.
• Organizational, time management and problem-solving skills
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients
• Flexibility to travel
• Driver’s license class B

What you can expect:

• Resources that promote your career growth
• Leaders that support flexible work schedules
• Programs to help you build your therapeutic knowledge
• Excellent working environment in a stabile, international, reputable company
• Company car, mobile phone and attractive benefits packaging

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com