Clinical Research Associate (Level I) - Netherlands, client dedicated

Overview

Clinical Research Associate (Level I) in a client-dedicated FSP team in the Netherlands, performing clinical monitoring and site management for sponsor trials.

What you'll do

• Monitor investigator sites using a risk-based monitoring approach, applying root cause analysis to identify site process failures and corrective/preventive actions.
• Ensure data accuracy through SDR, SDV and CRF review during on-site and remote monitoring.
• Assess investigational product through physical inventory and records review.
• Document observations in reports and letters in a timely manner using approved business writing standards.
• Escalate observed deficiencies and issues to clinical management and follow all issues through to resolution.
• Maintain regular contact between monitoring visits to confirm protocol adherence, resolution of identified issues and timely data recording.
• Conduct monitoring tasks in accordance with the approved monitoring plan.
• Participate in the investigator payment process.
• Share responsibility with project team members for issue and finding resolution; investigate and follow up on findings as applicable.
• Provide trial status tracking and progress update reports to the Clinical Team Manager (CTM).
• Ensure study systems such as the CTMS are updated per agreed study conventions and perform QC checks of CTMS-generated reports where required.
• Participate in investigator meetings as necessary.
• Identify potential investigators in collaboration with the client company and ensure acceptability of qualified investigative sites.
• Initiate clinical trial sites according to relevant procedures, ensuring compliance with the protocol, regulatory and ICH GCP obligations.
• Ensure trial close-out and retrieval of trial materials.
• Ensure required essential documents are complete and in place per ICH-GCP and applicable regulations; conduct on-site file reviews per project specifications.
• Contribute to project publications/tools and share ideas with team members.
• Perform additional study tasks as assigned by the CTM.
• Facilitate communication between investigative sites, the client company and the project team through written, oral and/or electronic contacts.
• Respond to company, client and applicable regulatory requirements, audits and inspections.
• Complete administrative tasks such as expense reports and timesheets in a timely manner.
• Contribute to process improvement initiatives as required.

What you'll need

• Bachelor's degree in a life sciences related field, or a Registered Nursing certification or equivalent, and relevant formal academic/vocational qualification.
• Previous experience comparable to 6 months to 1 year as a clinical research monitor.
• Valid full driver's licence.
• Effective clinical monitoring skills.
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.
• Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents.
• Well-developed critical thinking skills, including critical mindset, in-depth investigation for root cause analysis and problem solving.
• Ability to manage Risk Based Monitoring concepts and processes.
• Effective oral and written communication skills, with the ability to communicate effectively with medical personnel.
• Customer focus through good listening skills, attention to detail and ability to perceive customers' underlying issues.
• Effective interpersonal skills.
• Strong attention to detail.
• Effective organizational and time management skills.
• Ability to remain flexible and adaptable in a wide range of scenarios.
• Ability to work in a team or independently as required.
• Good computer skills: proficient knowledge of Microsoft Office and ability to learn appropriate software.
• Good Dutch, French and English language and grammar skills.
• Good presentation skills.

Details

• Work schedule: standard, Monday to Friday.
• Conducts remote or on-site visits.
• Location: Netherlands.