Syneos Health, Inc.
Clinical Research Associate België
Syneos Health, Inc., Sauk Trail Beach, Wisconsin, United States
Updated:
January 9, 2026 Location:
BEL-Remote Job ID: 25104952
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything we do. We continuously seek ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full‑Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate about changing lives.
Why Syneos Health
We are passionate about developing our people through career development and progression, supportive line management, technical and therapeutic area training, peer recognition and a total rewards program.
We are committed to our Total Self culture – where you can authentically be yourself. Our culture unites us globally and we are dedicated to taking care of our people.
We continuously build the company we all want to work for and our customers want to work with. By bringing together diverse thoughts, backgrounds, cultures and perspectives, we create a place where everyone feels they belong.
Job Responsibilities For one of our single‑sponsor partnerships, we are looking for an additional Clinical Research Associate to support the team in Belgium.
Performs site qualification, site initiation, interim monitoring, site management activities and close‑out visits (performed on‑site or remotely) ensuring regulatory, ICH‑GCP and/or Good Pharmacoepidemiology Practice (GPP), and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site‑specific actions; immediately communicates/escalates serious issues to the project team and develops action plans.
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting confidentiality of each subject/patient and assesses factors that might affect safety and data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
Assesses site processes per the Clinical Monitoring/Site Management Plan (CMP/SMP), conducts source document review of appropriate site source documents and medical records, verifies required clinical data entered on the case report form (CRF) is accurate and complete, applies query resolution techniques remotely and on site, and drives query resolution to closure within agreed timelines.
Mays perform investigational product (IP) inventory, reconciliation and reviews of storage and security. Verifies IP has been dispensed and administered to subjects/patients per protocol and assesses risks associated with blinded or randomized information related to IP.
Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness, reconciles contents of the ISF with the Trial Master File (TMF) and ensures the site is aware of archiving requirements in accordance with local guidelines and regulations.
Documents activities via confirmation letters, follow‑up letters, trip reports, communication logs and other required project documents as per SOPs and monitoring plan. Supports subject/patient recruitment, retention and awareness strategies and enters data into tracking systems to monitor all observations and action items.
Understands project scope, budgets and timelines; manages site‑level activities and communication to ensure project objectives, deliverables and timelines are met and adapts quickly to changing priorities.
Mays act as primary liaison with study site personnel or in collaboration with Central Monitoring Associate, ensuring all assigned sites and project‑specific site team members are trained and compliant with applicable requirements.
Prepares for and attends investigator meetings and/or sponsor face‑to‑face meetings. Participates in global clinical monitoring/project staff meetings (including sponsor representation, as applicable) and attends clinical training sessions according to project requirements.
Provides guidance at the site and project level toward audit readiness standards and supports preparation for audit and required follow‑up actions.
Maintains knowledge of ICH‑GCP Guidelines and other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required.
Qualifications
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.
Previous monitoring experience.
Good computer skills and ability to embrace new technologies.
Fluency in Dutch, French and English.
Excellent communication, presentation and interpersonal skills.
Ability to manage required travel for monitoring visits.
Get to Know Syneos Health Over the past 5 years, we have worked with 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.
No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever‑changing environment.
Summary Roles within Clinical Monitoring/CRA are responsible for overseeing and ensuring the integrity of clinical research studies by monitoring data and processes from a centralized location. This includes conducting remote monitoring of trial sites to verify compliance with regulatory requirements and clinical protocols, utilizing data analytics and risk‑based monitoring techniques to identify potential issues and trends, and collaborating with site teams to develop and implement tools, procedures and processes that enhance quality monitoring and support the overall success of clinical trials.
Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties or job responsibilities. Equivalent experience, skills and/or education will also be considered, and qualifications of incumbents may differ from those listed. The Company will determine what constitutes equivalence to the qualifications described above. This description does not create an employment contract. All language herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including implementation of the EU Equality Directive. The Company is committed to compliance with the Americans with Disabilities Act by providing reasonable accommodations when appropriate.
Equal Opportunity Statement Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against.
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January 9, 2026 Location:
BEL-Remote Job ID: 25104952
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything we do. We continuously seek ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full‑Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate about changing lives.
Why Syneos Health
We are passionate about developing our people through career development and progression, supportive line management, technical and therapeutic area training, peer recognition and a total rewards program.
We are committed to our Total Self culture – where you can authentically be yourself. Our culture unites us globally and we are dedicated to taking care of our people.
We continuously build the company we all want to work for and our customers want to work with. By bringing together diverse thoughts, backgrounds, cultures and perspectives, we create a place where everyone feels they belong.
Job Responsibilities For one of our single‑sponsor partnerships, we are looking for an additional Clinical Research Associate to support the team in Belgium.
Performs site qualification, site initiation, interim monitoring, site management activities and close‑out visits (performed on‑site or remotely) ensuring regulatory, ICH‑GCP and/or Good Pharmacoepidemiology Practice (GPP), and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site‑specific actions; immediately communicates/escalates serious issues to the project team and develops action plans.
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting confidentiality of each subject/patient and assesses factors that might affect safety and data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
Assesses site processes per the Clinical Monitoring/Site Management Plan (CMP/SMP), conducts source document review of appropriate site source documents and medical records, verifies required clinical data entered on the case report form (CRF) is accurate and complete, applies query resolution techniques remotely and on site, and drives query resolution to closure within agreed timelines.
Mays perform investigational product (IP) inventory, reconciliation and reviews of storage and security. Verifies IP has been dispensed and administered to subjects/patients per protocol and assesses risks associated with blinded or randomized information related to IP.
Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness, reconciles contents of the ISF with the Trial Master File (TMF) and ensures the site is aware of archiving requirements in accordance with local guidelines and regulations.
Documents activities via confirmation letters, follow‑up letters, trip reports, communication logs and other required project documents as per SOPs and monitoring plan. Supports subject/patient recruitment, retention and awareness strategies and enters data into tracking systems to monitor all observations and action items.
Understands project scope, budgets and timelines; manages site‑level activities and communication to ensure project objectives, deliverables and timelines are met and adapts quickly to changing priorities.
Mays act as primary liaison with study site personnel or in collaboration with Central Monitoring Associate, ensuring all assigned sites and project‑specific site team members are trained and compliant with applicable requirements.
Prepares for and attends investigator meetings and/or sponsor face‑to‑face meetings. Participates in global clinical monitoring/project staff meetings (including sponsor representation, as applicable) and attends clinical training sessions according to project requirements.
Provides guidance at the site and project level toward audit readiness standards and supports preparation for audit and required follow‑up actions.
Maintains knowledge of ICH‑GCP Guidelines and other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required.
Qualifications
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.
Previous monitoring experience.
Good computer skills and ability to embrace new technologies.
Fluency in Dutch, French and English.
Excellent communication, presentation and interpersonal skills.
Ability to manage required travel for monitoring visits.
Get to Know Syneos Health Over the past 5 years, we have worked with 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.
No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever‑changing environment.
Summary Roles within Clinical Monitoring/CRA are responsible for overseeing and ensuring the integrity of clinical research studies by monitoring data and processes from a centralized location. This includes conducting remote monitoring of trial sites to verify compliance with regulatory requirements and clinical protocols, utilizing data analytics and risk‑based monitoring techniques to identify potential issues and trends, and collaborating with site teams to develop and implement tools, procedures and processes that enhance quality monitoring and support the overall success of clinical trials.
Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties or job responsibilities. Equivalent experience, skills and/or education will also be considered, and qualifications of incumbents may differ from those listed. The Company will determine what constitutes equivalence to the qualifications described above. This description does not create an employment contract. All language herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including implementation of the EU Equality Directive. The Company is committed to compliance with the Americans with Disabilities Act by providing reasonable accommodations when appropriate.
Equal Opportunity Statement Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against.
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