Experienced CRA - Denmark

IQVIA LLC; København; On-site; DKK 500,000 - 700,000; Full time

Job summary

IQVIA LLC is seeking an Experienced CRA to Denmark to perform site monitoring and study management duties in accordance with GCP, ICH, and sponsor requirements. You will lead monitoring visits, support recruitment planning, and ensure regulatory and TMF/ISF documentation is maintained across assigned sites.

The role requires a Bachelor’s degree in a scientific or healthcare field and at least 2 years of on-site monitoring experience, with strong Danish and English communication skills.

Qualifications

• Bachelor's Degree in scientific discipline or health care preferred.
• At least 2 years of on-site monitoring experience.
• Equivalent combination of education, training and experience may be accepted.
• Good knowledge of GCP and ICH guidelines.
• Proficiency in Microsoft Word, Excel and PowerPoint; comfortable using a laptop and mobile devices.
• Written and verbal communication in Danish and English.
• Strong organizational, problem-solving, time and financial management skills.
• Ability to establish and maintain effective working relationships.

Responsibilities

• Perform site monitoring visits (initiation, routine monitoring, and close-out) per scope and GCP.
• Drive and track subject recruitment plans in line with project needs.
• Administer protocol training to sites and maintain regular communication.
• Evaluate site practices for protocol adherence and regulatory compliance.
• Track submissions, recruitment, CRF completion, data queries; support startup as needed.
• Maintain TMF and ISF documentation per regulatory requirements.
• Collaborate with study team for project execution and site support.
• Support site financial management and invoicing where applicable.

Skills

On-site monitoring

GCP/ICH knowledge

MS Office proficiency

Danish & English language

Education

Bachelor's Degree in scientific discipline or health care

Tools

Microsoft Word

Excel

PowerPoint

Job description

Experienced CRA - Denmark Job Overview Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Qualifications

• Bachelor's Degree Degree in scientific discipline or health care preferred.
• Requires at least 2 years of year of on-site monitoring experience.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.
• i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Good therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Written and verbal communication skills including good command of Danish and English language.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

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 IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.