[Hiring] Senior Clinical Research Associate @Thermo Fisher Scientific

Role Description

Join Us as a (Senior) Clinical Research Associate in our client dedicated FSP team - Belgium – Make an Impact at the Forefront of Innovation. As part of our global team, you’ll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Senior Clinical Research Associate (Level I), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation.

• Manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.).
• Ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs.
• Ensure audit readiness and develop collaborative relationships with investigational sites.
• Conduct monitoring tasks in accordance with the approved monitoring plan.
• Participate in the investigator payment process.
• Provide trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
• Facilitate effective communication between investigative sites, the client company, and the PPD project team.
• Maintain & complete administrative tasks such as expense reports and timesheets in a timely manner.

Qualifications

• Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic/vocational qualification.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as a clinical research monitor).
• Valid full driver's licence.

Requirements

• Fluency in Dutch, English, and French.
• 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 in-depth investigation for appropriate root cause analysis and problem solving.
• Ability to manage Risk Based Monitoring concepts and processes.
• Effective oral and written communication skills.
• Strong attention to detail and effective organizational and time management skills.
• Ability to work in a team or independently as required.
• Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software.
• Good presentation skills.

Benefits

• Flexible working conditions (fully remote or hybrid/office based).
• Opportunity to work with top pharmaceutical companies and biotechs.
• Exposure to a variety of clinical trials across multiple countries.

Working Conditions and Environment

• Work is performed in an office/laboratory/clinical/and/or home office environment with exposure to electrical office equipment.
• Frequent drives to site locations and travel, generally 60-80%.
• May include extended overnight stays.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Must comply with specific sponsor/client/site requirements.