Clinical Research Associate Denmark

Overview

Syneos Health is recruiting an experienced Clinical Research Associate to join its multi-sponsor business unit in Denmark, focused on monitoring clinical studies in Denmark, with cross-border monitoring in the Nordics possible.

What you'll do

• Perform site qualification, site initiation, interim monitoring, site management activities and close-out visits, on-site or remotely, ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
• Evaluate overall site and site staff performance and recommend site-specific actions; immediately escalate serious issues to the project team and develop action plans.
• Verify that informed consent has been adequately performed and documented for each subject/patient, and protect subject/patient confidentiality.
• Assess factors that might affect subject/patient safety and clinical data integrity, such as protocol deviations/violations and pharmacovigilance issues.
• Per the Clinical Monitoring/Site Management Plan, assess site processes, conduct source document review of site source documents and medical records, and verify CRF data is accurate and complete.
• Apply query resolution techniques remotely and on site, guide site staff as necessary, and drive query resolution to closure within agreed timelines.
• Use available hardware and software to support clinical study data review and capture, and verify site compliance with electronic data capture requirements.
• Perform investigational product (IP) inventory, reconciliation and storage/security review where applicable, and verify IP dispensing and administration per protocol.
• Verify issues or risks associated with blinded or randomized information related to IP, and ensure IP is appropriately (re)labelled, imported and released/returned.
• Routinely review the Investigator Site File (ISF) for accuracy, timeliness and completeness, reconcile it with the Trial Master File (TMF), and ensure sites archive essential documents per local guidelines and regulations.
• Document activities via confirmation letters, follow-up letters, trip reports, communication logs and other required project documents per SOPs and the Clinical Monitoring Plan/Site Management Plan.
• Support subject/patient recruitment, retention and awareness strategies, and enter data into tracking systems to track observations, status and action items to resolution.
• Understand project scope, budgets and timelines for assigned activities, and manage site-level activities and communication to meet project objectives, deliverables and timelines.
• Quickly adapt to changing priorities to achieve goals and targets.
• Act as primary liaison with study site personnel, or in collaboration with a Central Monitoring Associate.
• Ensure all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
• Prepare for and attend Investigator Meetings and/or sponsor face-to-face meetings, participate in global clinical monitoring/project staff meetings, and attend clinical training sessions per project requirements.
• Provide guidance at site and project level toward audit readiness standards and support audit preparation and required follow-up actions.
• Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes, and complete assigned training.

What you'll need

• Bachelor's degree or RN in a related field, or equivalent combination of education, training and experience.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Good computer skills and ability to embrace new technologies.
• Previous monitoring experience.
• Excellent communication, presentation and interpersonal skills.
• Fluency in Danish and English.
• Ability to manage required travel of up to 75% on a regular basis.

Nice to have

• A good understanding of Swedish and Norwegian.

Details

• Location: Denmark, with cross-border monitoring in the Nordics possible.
• Work mode: remote (location line listed as DNK-Remote).
• Travel of up to 75% on a regular basis.