Clinical Research Associate Level 2 (CRA 2)

About the role

IQVIA is looking for a CRA 2 in Copenhagen 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 covers site visits, recruitment planning, document control and liaison with the study team.

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, set up 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 regulations.
• Produce visit reports, follow-up letters and other documentation; support the start-up phase and, where applicable, site recruitment plans and site financial management and invoicing.

Required profile

• Bachelor's degree in a scientific discipline or health care preferred; 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 from company training.
• Written and verbal communication skills with a good command of 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)