Location: Belgium
Company: Syneos Health
Syneos Health® is a fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We specialize in translating clinical, medical, and commercial insights into actionable outcomes. We focus on simplifying the clinical development process and putting patients and customers at the center of everything we do. By fostering collaboration and innovation, we are driven to deliver life-changing therapies and accelerate time-to-market.
Syneos Health is currently seeking a Clinical Research Associate II (CRA II) to join our team in Belgium. The CRA II will perform a variety of site management responsibilities for clinical trials, including site qualification, initiation, monitoring, and close-out visits. This role involves ensuring compliance with regulatory requirements, ICH-GCP guidelines, and study protocols while supporting site staff and managing trial progress. The CRA II will also be responsible for managing site-specific issues, providing guidance, and contributing to the overall success of clinical studies.
Site Management & Monitoring:
Conduct site qualification, initiation, interim monitoring, site management, and close-out visits (either on-site or remotely). Assess site performance and escalate issues as needed. Ensure regulatory and protocol compliance, and collaborate with the project team to develop action plans for resolution.
Regulatory & Protocol Compliance:
Ensure proper informed consent processes are followed, ensuring confidentiality and patient safety. Monitor for protocol deviations and pharmacovigilance issues, taking appropriate action to address concerns and maintain clinical data integrity.
Data Review & Source Documentation:
Perform Source Document Review (SDR) and Source Data Verification (SDV) to verify that data entered in the case report form (CRF) is accurate and complete. Resolve queries remotely or on-site and guide site staff through resolution to meet agreed timelines.
Investigational Product (IP) Management:
Oversee investigational product (IP) inventory, reconciliation, storage, and security. Ensure that IP is dispensed and administered according to protocol and resolve any issues related to blinded or randomized IP. Ensure proper labeling, importation, and return processes are followed.
Investigator Site File (ISF) Management:
Review the Investigator Site File (ISF) for completeness, accuracy, and timeliness, and ensure it is aligned with the Trial Master File (TMF). Ensure sites are aware of archiving requirements and that essential documents are maintained according to local guidelines and regulations.
Project Coordination:
Manage site-level activities to ensure study milestones, timelines, and deliverables are met. Adapt to changing priorities to achieve study goals and provide proactive communication with internal teams and site personnel.
Training & Mentorship:
Provide site-level training to ensure compliance with study protocols and regulatory requirements. Mentor junior CRAs and assist in the development and training of new site staff.
Audit Readiness & Compliance:
Ensure sites are prepared for audits by maintaining documentation and supporting audit preparation. Guide sites toward maintaining audit-ready standards throughout the study lifecycle.
Travel:
Travel up to 50% of the time to visit sites across Belgium and attend Investigator Meetings and Sponsor meetings as required.
Education:
Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
Experience:
Skills & Competencies:
Syneos Health is committed to developing our people through career progression, technical training, peer recognition, and a comprehensive rewards program. Our Total Self culture fosters an inclusive environment where you can bring your authentic self to work. We value diverse perspectives and are passionate about changing lives through innovative therapies.
Tasks, duties, and responsibilities outlined in this job description are not exhaustive. The company may assign additional tasks at its discretion. The company is committed to compliance with the Americans with Disabilities Act and local legislation related to equal employment opportunities. Reasonable accommodations will be provided as necessary to assist employees or applicants in performing essential job functions.
Andra Pradesh :
Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Visakhapatnam |Assam :
Dibrugarh | Diburghar | Guwahati |Bihar :
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Bilaspur | Eot Municipality | Raipur |Delhi :
Delhi | India | New Delhi | PAN-India |Goa :
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Ahmedabad | Baroda | Gandhinagar | Halol | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
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Baddi | Solan |India :
Siliguri |Jharkhand :
Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Mangaluru | Mysore | Udupi |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram |Madhya Pradesh :
Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Maharashtra :
Ambernath | Amravati | Aurangabad | Dhule | Jalgaon | Kolhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tarapur | Thane | Vikhroli |Odisha :
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Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Sikkim :
Rangpo |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tiruchirappalli | Trichy |Uttar Pradesh :
Gajraula | Gautam buddha Nagar | Ghaziabad | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Varanasi |Uttarakhand :
Dehradun | Nainital | Rishikesh |West Bengal :
Digha | Kolkata | Mukundapur |Alabama :
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Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Tempe | Tucson | Yuma |Arkansas :
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Alameda | Albion | Arcata | Berkeley | Brisbane | Burney | California | Carlsbad | Crescent City | Davis | Downey | El Monte | El Segundo | Emeryville | Eureka | Fortuna | Foster City | Fremont | Glendale | Hoopa | Irvine | La Jolla | Los Angeles | Martinez | McKinleyville | Menlo Park | Morgan Hill | Mountain View | Nevada | Oakland | Pacheco | Palo Alto | Pasadena | Pleasanton | Redding | Redwood City | Riverside | Sacramento | San Bernardino | San Diego | San Francisco | San Gabriel | San Jose | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | South San Francisco | Stanford | Stanton | Stockton | Temecula | Thousand Oaks | Valencia | Vallejo | West Valley City | Whittier | Willits |Colorado :
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Boca Raton | Clearwater | Coral Gables | Coral Springs | Daytona Beach | Gainesville | Jacksonville | Maitland | Miami | Naples | Orlando | Pembroke Pines | Port St. Lucie | Rueil-Malmaison | Stuart | Tallahassee | Tampa | West Palm Beach |Georgia :
Atlanta | Rome |Hawaii :
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Farmington | Santa Fe | Tucumcari |New York :
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Donegal |New South Wales :
Ballina | Sydney |Queensland :
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Amsterdam |Netherlands :
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Haarlem |South Holland :
Leiden |Buenos Aires :
Buenos Aires |Austria :
Austria |Vienna :
Vienna |Antwerp :
Heist op den Berg |Brussels :
Brussels |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
Canada |Ontario :
Mississauga | Uxbridge | Richmond Hill | North York |Quebec :
Montreal |Chile :
Santiago |Republic of Colombia :
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Croatia |Zagreb :
Zagreb |Bohemia :
Prague |Republic of Egypt :
Cairo |South Yorkshire :
Sheffield |United Kingdom :
Maidenhead | Salt Lake City | London | Harlow | Leeds | Stirling | United Kingdom |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Chuuk :
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Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |France :
Lyon | Paris |Attica :
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Greece |East Java :
Surabaya |Jakarta :
Jakarta |Israel :
Tel Aviv | Be'Er Sheva | Yavne | Netanya | Kfar Saba |Italy :
Italy |Lombardy :
Rho |Japan :
Japan |Tokyo :
Otemachi |Kazakhstan :
Almaty |Remote Korea :
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Kuala Lumpur |Mexico :
Ciudad de México |Cebu Province :
Cebu City |Philippines :
Manila |Mazovia :
Warsaw |Remote :
Remote, USA | Remote - Middle East | Remote | Switzerland | Remote - Europe |Bucharest :
Bucharest |Makkah :
Najran | Rabigh | Khulais | King Abdullah Economic City | Jeddah | Riyadh |Nišava District :
Niš |Singapore :
Singapore |South Africa :
Midrand |Brazil :
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Argentina |Catalonia :
Barcelona |Madrid :
Madrid |Sweden :
Sweden |Taipei :
Taipei |Williamson :
Brentwood |Republic of Thailand :
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Kyiv |Dubai :
Dubai |Hà Nội :
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Ho Chi Minh City |