Experienced CRA - Denmark

About the role

iQVIA is looking for an experienced Clinical Research Associate (CRA) based in Copenhagen, Denmark. The role covers monitoring and site management so that study sites carry out their studies and report data as required by the protocol, regulations, guidelines and sponsor requirements.

Key responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) according to the contracted scope of work and Good Clinical Practice.
• Work with sites to adapt, drive and track the subject recruitment plan in line with project needs.
• 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 regulations.
• Create documentation such as visit reports, follow-up letters and action plans.
• Liaise with the study team; may support the start-up phase, site recruitment plans 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 good command of Danish and 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.