Clinical Research Associate: Site Monitoring & Study Mgmt

IQVIA; København; On-site; DKK 480,000 - 600,000; Full time

Job summary

IQVIA LLC in Denmark seeks a Site Monitoring Specialist to ensure study sites conduct and report data per protocol, GCP/ICH guidelines, and sponsor requirements. You will perform monitoring visits, support site start-up, and maintain high-quality study conduct across assigned sites.

On-site in the Copenhagen region, you will coordinate subject recruitment plans, ensure TMF/ISF documentation, and manage CRF submissions and data queries, applying strong organizational and communication skills to

Qualifications

• Bachelor's degree in scientific discipline or health care preferred.
• Requires at least 1 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., GCP and ICH).
• Good therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in 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 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.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., GCP and ICH guidelines
• 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, 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 TMF and verify that 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.

Skills

Communication skills

GCP/ICH knowledge

Microsoft Office

Time & financial management

Education

Bachelor's degree in scientific discipline or health care

Tools

Word

Excel

PowerPoint

Job description

IQVIA LLC in Denmark seeks a Site Monitoring Specialist to ensure study sites conduct and report data per protocol, GCP/ICH guidelines, and sponsor requirements. You will perform monitoring visits, support site start-up, and maintain high-quality study conduct across assigned sites.

On-site in the Copenhagen region, you will coordinate subject recruitment plans, ensure TMF/ISF documentation, and manage CRF submissions and data queries, applying strong organizational and communication skills to