CRA Belgium

For one of our FSP models we are currently recruiting for an experienced Clinical Research Associate to cover Belgium.

Syneos Health is a prominent fully integrated biopharmaceutical solutions organization focused on driving customer success. We transform unique clinical, medical affairs, and commercial insights into outcomes to tackle modern market challenges.

At the core of our Clinical Development model lies the focus on both the customer and the patient. We are constantly seeking ways to simplify and optimize our processes to not only make working with Syneos Health more seamless, but also to make us a more attractive employer.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you will work alongside dedicated problem solvers, collaborating as a team to assist our customers in reaching their objectives. We are dynamic and motivated to accelerate the delivery of treatments because we are driven by the desire to make a positive impact on people's lives.

Discover what our 29,000 employees, spread across 110 countries, already understand: YOUR CONTRIBUTION HERE MAKES A DIFFERENCE EVERYWHERE

Why choose Syneos Health

• We are dedicated to the continuous development of our employees, offering opportunities for career growth and advancement; supportive and involved management; training in technical and therapeutic areas; peer acknowledgement and comprehensive rewards programs.
• We uphold our Total Self culture - enabling you to be your authentic self. Our Total Self culture is the common thread that binds us globally, and we are committed to nurturing our employees.
• We are consistently shaping the kind of company we all want to work for and that our clients desire to collaborate with. Why? Because by uniting a diversity of thoughts, backgrounds, cultures, and perspectives, we can create an environment where everyone feels they belong.

Job responsibilities

• Conducts site qualification, initiation, interim monitoring, site management tasks, and close-out visits (performed on-site or remotely) to ensure compliance with regulatory standards, ICH-GCP, Good Pharmacoepidemiology Practice (GPP), and the protocol. Assesses overall site performance and staff competency, providing suggestions for site-specific actions; promptly escalates critical issues to the project team and devises action plans. Possesses a proficient understanding of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes.
• Validates the informed consent process for each subject/patient has been properly executed and documented, as necessary. Demonstrates commitment to safeguarding subject/patient confidentiality. Identifies factors that could impact subject/patient safety and the integrity of clinical data at an investigator/physician site, such as protocol deviations/violations and pharmacovigilance concerns.
• In accordance with the Clinical Monitoring/Site Management Plan (CMP/SMP):
  • Evaluates site procedures
  • Conducts Review of Source Documents from the site and medical records
  • Confirms the accuracy and completeness of clinical data entered in the case report form (CRF)
  • Addresses queries both remotely and on site, and provides guidance to site staff as needed, ensuring timely query resolution
  • Leverages available tools and software to facilitate efficient management of clinical study data review and collection
  • Confirms site adherence to electronic data capture requirements
• May handle investigational product (IP) inventory, reconciliation, and oversee storage and security. Validates the dispensing and administration of IP to subjects/patients aligns with the protocol. Identifies and mitigates risks associated with blinded or randomized information pertaining to the IP.
• Applies expertise in GCP/local regulations and company procedures to ensure appropriate (re)labeling, importation, and release/return of IP.
• Regularly reviews the Investigator Site File (ISF) for accuracy, timeliness, and completeness. Aligns ISF contents with the Trial Master File (TMF). Ensures the investigator/physician site understands the necessity of archiving essential documents in compliance with local regulations.
• Documents activities through confirmation letters, follow-up correspondences, trip reports, communication logs, and other pertinent project documents following SOPs and Clinical Monitoring Plan/Site Management Plan. Supports strategies for subject/patient recruitment, retention, and awareness. Inputs data into tracking systems to monitor all findings, progress status, and assigned action items until resolution.
• Grasps project scope, budgets, and timelines for assigned tasks; oversees site-level activities/communications to meet project objectives, deliverables, and timelines. Must be adaptable to changing priorities to achieve goals/targets expeditiously.
• Acts as the primary point of contact with study site personnel, or collaborates with Central Monitoring Associate. Ensures all designated sites and project-specific site team members receive training and comply with relevant requirements.
• Prepares for and attends Investigator Meetings and/or sponsor meetings in person. Engages in global clinical monitoring/project staff meetings (inclusive of Sponsor participation, when applicable) and attends clinical training sessions as per project specifications.
• Provides guidance at the site and project levels to maintain audit readiness standards and supports audit preparation and necessary follow-up actions.
• Maintains a solid understanding of ICH/GCP Guidelines, other pertinent guidance, applicable regulations, and company SOPs/processes; completes mandated training as needed.

Qualifications

Desired Profile

• A motivated new team member
• Holds a Bachelor's degree or RN in a related field or equivalent mix of education, training, and experience
• Prior monitoring experience within Belgium
• Familiarity with Good Clinical Practice/ICH Guidelines and other relevant regulatory mandates
• Demonstrates strong computer skills and a willingness to adopt new technologies
• Excellent written and verbal communication, presentation, and interpersonal skills. Proficient in Dutch, French, and English
• Able to manage necessary travel for monitoring visits

Discover Syneos Health

Over the past half-decade, we have collaborated on 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

Irrespective of your role, you will proactively challenge conventions with us in a fiercely competitive and ever-evolving landscape. Learn more about Syneos Health.

Additional Information:
Responsibilities listed in this job description may not encompass all tasks, duties, and obligations. The Company retains the right to assign additional responsibilities at its discretion and without prior notice. Equivalent experience, skills, and/or education will also be taken into account, potentially resulting in differences from the listed qualifications. The Company reserves the authority to define what qualifies as equivalent to the described qualifications. Nothing in this description should be interpreted as establishing an employment contract. Occasionally, essential skills/experiences for jobs are summarized briefly. The language used here aims to comply fully with the legal requirements of all countries in which the Company operates, including adherence to EU Equality Directive regulations concerning employee recruitment and employment. The Company is devoted to complying with the Americans with Disabilities Act, offering reasonable accommodations, where appropriate, to aid employees or applicants in carrying out the job's essential functions.

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