Clinical Research Associate (CRA level I) - FSP

Overview

Clinical Research Associate (CRA level I) role within the FSP model, monitoring investigator sites for a world-leading CRO.

What you'll do

• Monitor investigator sites using a risk-based monitoring approach, applying root cause analysis, critical thinking and problem-solving to identify site process failures and corrective/preventive actions.
• Ensure data accuracy through SDR, SDV and CRF review through on-site and remote monitoring activities.
• Assess investigational product through physical inventory and records review.
• Document observations in reports and letters according to timelines using approved business writing standards.
• Escalate observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
• Maintain regular contact between monitoring visits with investigative sites to confirm protocol adherence, resolution of previously identified issues and timely data recording, as needed.
• Participate in the investigator payment process.
• Share responsibility with other project team members for issues and findings resolution, and investigate and follow up on findings as applicable.
• Participate in investigator meetings as necessary.
• Identify potential investigators in collaboration with the client company to ensure acceptability of qualified investigative sites.
• Initiate clinical trial sites according to relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted.
• Perform trial close-out and retrieval of trial materials.
• Ensure required essential documents are complete and in place according to ICH-GCP and applicable regulations.
• Conduct on-site file reviews as per project specifications.
• Provide trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
• Ensure study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).
• Contribute to the project team by assisting in preparation of project publications/tools and sharing ideas and suggestions with team members.
• Contribute to other project work and process improvement initiatives as required.

What you'll need

• University degree in a science-related field.
• Understanding of ICH-GCP, EU and FDA requirements.
• Fluency in English, French and Dutch.
• Valid driver's license.
• Proven clinical monitoring skills.
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.
• Demonstrated ability to attain and maintain working knowledge of ICH GCPs, applicable regulations and procedural documents.
• Well-developed critical thinking skills, including critical mindset, in-depth investigation for appropriate root cause analysis and problem solving.
• Ability to manage Risk Based Monitoring concepts and processes.
• Good oral and written communication skills, with the ability to communicate effectively with medical personnel.
• Ability to maintain customer focus through good listening skills, attention to detail and perceiving customers' underlying issues.
• Good organizational and time management skills.
• Effective interpersonal skills and attention to detail.
• 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: solid knowledge of Microsoft Office and ability to learn appropriate software.
• CRA with experience from all study phases from start to close-out.

Details

• Location: Remote, Belgium.
• Work schedule: Standard (Mon-Fri), office environmental conditions.
• Flexible working culture.