Senior Clinical Research Associate I – Home-Based, France
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization committed to accelerating customer success. We leverage unique clinical, medical affairs, and commercial insights to achieve outcomes that address modern market realities.
Our Clinical Development model puts the customer and the patient at the heart of everything we do. We are always striving to simplify and streamline our operations to make Syneos Health easier to work with and a better place to work for our employees.
Whether you join us in a Functional Service Provider partnership or in a Full-Service environment, you’ll collaborate with passionate problem-solvers, innovating together to help our customers reach their goals. We are agile and committed to delivering therapies that change lives.
At Syneos Health, we are dedicated to developing our people. We offer career progression opportunities, supportive line management, training in technical and therapeutic areas, peer recognition, and a comprehensive rewards program. Our Total Self culture fosters an environment where you can be your authentic self, and we take pride in creating a place where everyone feels they belong.
Site Management & Monitoring:
Conduct site qualification, initiation, interim monitoring, and close-out visits (on-site or remotely), ensuring compliance with ICH-GCP, Good Pharmacoepidemiology Practice (GPP), and study protocols. Assess site performance, provide recommendations for improvement, and escalate serious issues to the project team with action plans.
Informed Consent & Patient Safety:
Ensure informed consent is properly obtained and documented. Safeguard patient confidentiality and assess site compliance to protocols, identifying risks related to protocol deviations, pharmacovigilance issues, and patient safety.
Clinical Data & Source Document Review:
Review and verify source documents and clinical data entered in case report forms (CRFs), ensuring accuracy and completeness. Apply query resolution techniques to address data issues and guide site staff to closure within agreed timelines.
Investigational Product (IP) Management:
Oversee IP inventory, storage, and security, ensuring IP is dispensed according to protocol and relevant regulations. Ensure proper labeling, importation, and release/return procedures of IP.
Site File Maintenance & Documentation:
Ensure the Investigator Site File (ISF) is complete and up to date. Reconcile the ISF with the Trial Master File (TMF) and ensure sites comply with archiving requirements according to local regulations.
Project Coordination & Communication:
Manage site-level activities to meet project objectives, timelines, and deliverables. Adapt to changing priorities and communicate effectively with project site personnel, the Central Monitoring Associate, and project teams.
Audit Readiness & Compliance:
Maintain readiness for audits, assist in preparation, and ensure follow-up actions are taken.
Mentorship & Training:
Provide mentorship and training to junior CRAs and may be involved in training and sign-off visits for new CRA staff. Potential to lead clinical operations tasks under supervision.
Real World Late Phase (RWLP) Responsibilities:
As the Senior CRA I, act as the Senior Site Management Associate I, supporting the site throughout its lifecycle—from identification to close-out. Responsibilities include:
Over the last five years, Syneos Health has worked on 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and conducted more than 200 studies across 73,000 sites, with over 675,000 trial patients. Join us to take initiative, challenge the status quo, and make a meaningful impact in the healthcare and pharmaceutical industry.
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 | 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 | 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 |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 |New South Wales :
Sydney |Queensland :
Queensland |Republic of Western Australia :
Nedlands |Hubei :
Wuhan |Republic of China :
Beijing |Tokiyo :
Tokyo | Osaka |Republic of Colombia :
Bogota |Zagreb :
Zagreb |Republic of Egypt :
Cairo |United Kingdom :
Harlow | London | Salt Lake City |Republic of Ireland :
Limerick | Dublin |Israel :
Kfar Saba | Tel Aviv |Republic of Korea :
Seoul |Capital of Netherland :
Amsterdam |Remote :
Remote | Switzerland | Remote - Europe | Remote, USA |Makkah :
Jeddah | Riyadh | Najran | Khulais | Rabigh |Catalonia :
Barcelona |Republic of Thailand :
Bangkok |