Location: Belgium
Company: Syneos Health
Syneos Health® is a leading global biopharmaceutical solutions organization that accelerates customer success by translating clinical, medical, and commercial insights into impactful outcomes. We are dedicated to simplifying and streamlining the clinical development process to make it easier for our customers and employees. Our Clinical Development model places both customers and patients at the center of everything we do. We foster a collaborative, innovative, and agile environment to help deliver life-changing therapies faster.
Discover why Syneos Health is a company where working matters everywhere.
We are seeking a Clinical Research Associate II (CRA II) to join our team in Belgium. In this role, you will be responsible for managing clinical trial sites from start-up through to close-out. You will ensure compliance with regulatory requirements, ICH-GCP guidelines, and study protocols, while supporting sites in delivering high-quality data. As a CRA II, you will perform site qualifications, monitor trial progress, manage site performance, and contribute to the overall success of clinical studies.
Site Management:
Perform site qualification, initiation, interim monitoring, site management, and close-out visits (on-site or remotely). Evaluate site performance and escalate any serious issues to the project team, developing corrective action plans as needed.
Regulatory Compliance:
Ensure informed consent is obtained appropriately, protecting patient confidentiality, and monitor for protocol deviations and pharmacovigilance issues that may impact patient safety or data integrity.
Clinical Monitoring:
Investigational Product (IP) Management:
Oversee IP inventory, reconciliation, and storage. Ensure IP is dispensed and administered per the protocol and verify compliance with GCP and local regulations related to blinded or randomized information.
Documentation & Tracking:
Review and reconcile Investigator Site File (ISF) contents with the Trial Master File (TMF). Ensure essential documents are archived in compliance with local regulations. Document activities such as trip reports, follow-up letters, and communication logs.
Project Coordination:
Ensure project deliverables and timelines are met for site-level activities, adjusting to changes in priorities as necessary. Provide proactive communication to manage site expectations and deliverables.
Training & Mentorship:
Ensure sites and team members are trained on protocol requirements. Mentor junior CRAs and assist in the development of new team members.
Audit Readiness:
Prepare for site audits and ensure sites maintain audit-ready standards. Support preparation for audits and follow-up actions as required.
Travel Requirements:
This position requires up to 50% travel across Belgium to visit clinical trial sites.
Education:
Bachelor’s degree in a related field, or RN, or an equivalent combination of education, training, and experience.
Experience:
Skills & Competencies:
At Syneos Health, we are passionate about career development and progression. We offer supportive management, technical training, mentorship opportunities, and a Total Self culture that encourages you to bring your authentic self to work. We value diversity and inclusion, and we believe that together, we can create a workplace where everyone feels they belong.
The tasks and responsibilities in this job description are not exhaustive. The company may assign additional tasks and duties as required. Syneos Health is committed to equal employment opportunities and complies with local regulations, including those related to the Americans with Disabilities Act and the EU Equality Directive.
Andra Pradesh :
Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Tirupathi | Visakhapatnam |Assam :
Dibrugarh | Diburghar | Guwahati |Bihar :
Hajipur | Patna |Chhattisgarh :
Bilaspur | Raipur |Delhi :
Delhi | India | New Delhi | PAN-India |Goa :
Goa | Panaji |Gujarat :
Ahmedabad | Baroda | Gandhinagar | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
Ambala | Hisar | Kurukshetra | Panchkula | Rohtak |Himachal Pradesh :
Solan |Jharkhand :
Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Mangaluru | Mysore | Udupi |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram |Madhya Pradesh :
Dewas | Gwalior | Indore | Khandwa | Khargone | Ujjain |Maharashtra :
Ambernath | Amravati | Aurangabad | Jalgaon | Kolhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tarapur | Thane |PAN-India :
Panjab :
Punjab :
Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
Banasthali | Jaipur | Pilani | Udaipur |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | 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 :
Kolkata | Mukundapur |Alabama :
Birmingham |Alaska :
Anchorage | Barrow | Bethel | Juneau | Wrangell |Arizona :
Chandler | Kingman | Lake Havasu City | Peridot | Phoenix | Tempe | Tucson | Yuma |California :
Brisbane | Crescent City | Davis | El Monte | Emeryville | Foster City | Fremont | Irvine | La Jolla | Los Angeles | Martinez | Mountain View | Nevada | Oakland | Pacheco | Palo Alto | Pasadena | Pleasanton | Redwood City | Riverside | Sacramento | San Bernardino | San Diego | San Francisco | San Gabriel | San Jose | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | Stanford | Vallejo | West Valley City | Whittier | Willits |Colorado :
Denver |Connecticut :
Storrs |D.C :
Washington |Florida :
Coral Gables | Gainesville | Jacksonville | Naples | Orlando | Rueil-Malmaison | Tallahassee | Tampa | West Palm Beach |Georgia :
Atlanta |Hawaii :
Honolulu |Illinois :
Abbott Park | Champaign | Chicago | Deerfield | Lombard | Naperville | Round Lake |Indiana :
Bloomington | West Lafayette |Kansas :
Lawrence |LA :
Monroe | New Orleans |Maryland :
Baltimore | Elkridge | Rockville |Massachusetts :
Boston | Cambridge | Medford and Somerville | Rockland |Minnesota :
Minneapolis and St. Paul, Minnesota. |Missouri :
Fulton | St. Louis |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Mount Arlington | New Brunswick | Newark | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | West Orange | Westfield | Wharton | Whippany |New York :
Biddle | Buffalo | Hicksville | Ithaca | Morningside Heights | New York | Rensselaer | Syracuse |North Carolina :
Concord |North Caroline :
Chapel Hills | Durham | Morrisville | Philippines | Raleigh | Scottsdale |Ohio :
Columbus, |Oregon :
Bend | Corvallis | Eugene | Roseburg | Springfield |Pennsylvania :
Ambler | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | West Chester | Wyomissing |Portugal :
Lisbon |Puerto Rico :
San Juan |Republic of Mexico :
Mexico |Tennessee :
Nashville |Texas :
Austin | Dallas | Houston | Richardson |Virginia :
Blacksburg | Charlottesville | Falls Church |Washington :
Goldendale | Pullman | Seattle |WI :
Madison | Wausau |Wisconsin :
Wyoming :
Cokeville |Baden-Wurttemberg :
Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Berlin :
Mitte |Brandenburg :
Berlin |Hesse :
Marburg |Hessen :
Frankfurt |Lower Saxony :
Gottingen | Hannover | Leipzig |Mecklenburg Vorpommern :
Rostock |Munich :
Bavaria |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
Mainz |Rotherbaum :
Hamburg |Saarland :
Saarbrucken |Saxony Anhalt :
Halle |Schleswig Holstein :
Kiel |Denmark :
Copenhagen |Hungary :
Budapest |Istanbul :
Turkey |Serbia :
Belgrade |Switzerland :
Basel | Zurich |Hubei :
Wuhan |Republic of China :
Beijing |Shanghai Sai :
Shanghai Shi |Tokiyo :
Osaka | Tokyo |New South Wales :
Sydney |Queensland :
Queensland |Republic of Western Australia :
Nedlands |Quebec :
Montreal |Republic of Colombia :
Bogota |Zagreb :
Zagreb |Republic of Egypt :
Cairo |United Kingdom :
Salt Lake City | Harlow | London |Jakarta :
Jakarta |Republic of Ireland :
Dublin | Limerick |Israel :
Netanya | Kfar Saba | Tel Aviv |Republic of Korea :
Seoul |Capital of Netherland :
Amsterdam |Noord Holland :
Haarlem |Remote :
Remote - Europe | Remote | Remote, USA | Switzerland |Makkah :
Jeddah | Rabigh | Najran | Khulais | Riyadh |Catalonia :
Barcelona |Republic of Thailand :
Bangkok |