Location: Belgium
Company: Syneos Health
Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization that accelerates customer success by translating clinical, medical affairs, and commercial insights into actionable outcomes. Our goal is to simplify and streamline processes while keeping the customer and patient at the center of everything we do. Join us as we innovate, collaborate, and deliver life-changing therapies.
We are seeking an experienced Senior Clinical Research Associate (CRA) to join our Belgian team. In this role, you will ensure the compliance, safety, and efficiency of clinical trials by performing site qualification, initiation, monitoring, and close-out visits. You will work closely with the clinical team and site personnel to ensure all aspects of the trial are executed effectively, in line with regulatory requirements, ICH-GCP guidelines, and protocol specifications.
Site Monitoring & Management:
Perform site qualification, initiation, monitoring, and close-out visits (either on-site or remotely). Evaluate the performance of study sites and staff, provide recommendations, and address any issues by developing action plans in collaboration with the project team.
Regulatory Compliance:
Ensure all activities are compliant with ICH-GCP, GPP, and applicable regulatory guidelines. Review informed consent procedures and confirm the confidentiality of patient data. Identify and address issues affecting patient safety and clinical data integrity.
Data Review & Source Documentation:
Conduct Source Document Review (SDR) and Source Data Verification (SDV) to ensure clinical data accuracy. Resolve any discrepancies or queries through effective communication with site staff, ensuring compliance with electronic data capture and clinical data entry requirements.
Investigational Product (IP) Management:
Oversee IP inventory, reconciliation, storage, and security. Ensure investigational product is dispensed and administered per protocol, and resolve any issues related to blinded or randomized information.
Site File Maintenance:
Regularly review the Investigator Site File (ISF) for completeness, accuracy, and timeliness, ensuring it aligns with the Trial Master File (TMF). Support sites with archiving essential documents according to local guidelines and regulations.
Training & Mentorship:
Provide guidance to junior CRAs and assist in their training and sign-off visits. Support site staff training on study requirements and audit readiness.
Project Management:
Ensure project scope, timelines, and budgets are met by managing site-level activities and communications. Adapt to changing priorities to ensure the successful delivery of clinical study goals.
Collaboration & Meetings:
Collaborate with project site personnel and participate in Investigator Meetings, Sponsor meetings, and global clinical monitoring project staff meetings. Provide audit readiness support and prepare for audits and follow-up actions.
Education:
Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
Experience:
Skills & Competencies:
At Syneos Health, we’re driven to accelerate the delivery of therapies that change lives. We are passionate about developing our people and creating a diverse, inclusive culture where everyone feels like they belong. With our global reach, we offer a collaborative and dynamic work environment that allows you to thrive both personally and professionally.
Tasks, duties, and responsibilities in this job description are not exhaustive. The company may assign additional tasks at its discretion. We are committed to compliance with all applicable laws, including the EU Equality Directive, the Americans with Disabilities Act, and other regulations related to recruitment and employment.
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 :
Harlow | Salt Lake City | London |Jakarta :
Jakarta |Republic of Ireland :
Dublin | Limerick |Israel :
Netanya | Tel Aviv | Kfar Saba |Republic of Korea :
Seoul |Capital of Netherland :
Amsterdam |Noord Holland :
Haarlem |Remote :
Remote - Europe | Remote, USA | Remote | Switzerland |Makkah :
Jeddah | Rabigh | Riyadh | Najran | Khulais |Catalonia :
Barcelona |Republic of Thailand :
Bangkok |