Senior Clinical Research Associate

This is a fully remote position, open to applicants in Denmark.

📋 Description

• Initiate, oversee, and conclude study sites both on-site and remotely during the course of the study.

• Provide unmasked Clinical Research Associate support for designated clinical studies.

• Manage accountability for investigational products and supervise unblinded site activities.

• Ensure compliance with protocols as per study requirements and relevant regulations.

• Collaborate with study teams, investigative sites, and sponsors to guarantee timely study deliverables, maintain study blinding, and ensure data quality.

• Monitor clinical trials in line with company or sponsor SOPs, GCP, ICH guidelines, and applicable regulations.

• Conduct monitoring activities to evaluate subject safety, data integrity, and quality.

• Confirm informed consent procedures and adherence to protocols.

• Review electronic or paper CRFs and source documents for validity and accuracy.

• Document findings from monitoring visits, report actions taken, and update tracking systems while escalating issues as necessary.

• Provide sites with identified challenges and action items.

• Deliver site documents to the eTMF or paper TMF.

• Ensure proper maintenance of the Investigator Site File.

• Update CTMS and other project systems with accurate site information.

• Engage in audit and inspection preparation as well as follow-up activities.

• Order, ship, and reconcile clinical investigative supplies when needed.

• Assist Clinical Research or Project Managers with project tracking, monitoring plans, report reviews, and CRA resource management.

• Conduct Assessment Site Visits upon request.

• Mentor CRAs and develop training for therapeutic areas.

• Take part in capabilities presentations.

⛳️ Requirements

• Bachelor’s Degree, preferably in life sciences or nursing, or an equivalent qualification.

• Over 5 years of independent on-site monitoring experience.

• Minimum of 1 year of experience as an unmasked monitor.

• At least 1 year of experience in Ophthalmology preferred, ideally within a retina indication.

• Familiarity with basic medical terminology and scientific concepts related to assigned drugs and therapeutic areas.

• Knowledge of Good Clinical Practice regulations and ICH guidelines.

• Ability to operate independently as well as within a team matrix organization.

• Exceptional written and verbal communication skills.

• Proficient in English and the local language.

• Strong organizational abilities.

• Tech-savvy with proficient software and computer skills.

• Capability to thrive in a fast-paced environment with shifting priorities.

• Experience managing complex or early-phase studies.

• Willingness and ability to travel 60–80%, including overnight and international trips if necessary.

• Self-awareness, determination, adaptability, collaborative attitude, proactivity, analytical mindset, attention to detail, coachability, motivation, facilitation, and diplomacy.

• Ability to take ownership of assigned responsibilities.

🏝️ Benefits

• Competitive compensation package.

• Comprehensive benefits.

• Opportunities for personal and professional growth.

• A collaborative and innovative work environment.

• The chance to make a meaningful impact in patients’ lives.