About Syneos Health
Syneos Health® is a leading integrated biopharmaceutical solutions organization focused on accelerating customer success. We translate clinical, medical affairs, and commercial insights into impactful outcomes, addressing the complexities of modern healthcare.
Our Clinical Development model places both customers and patients at the center of our work. We are committed to simplifying processes to enhance collaboration and drive the delivery of life-changing therapies.
Why Syneos Health?
Development Opportunities: We are dedicated to fostering professional growth through career development, supportive management, technical training, and peer recognition.
Inclusive Culture: Our Total Self culture encourages you to be your authentic self, creating a diverse environment where everyone feels they belong.
Global Impact: Join our team of 29,000 employees across 110 countries and discover how your work can make a difference.
Role Overview
As a Senior Clinical Research Associate I (SCRA I), you will oversee monitoring and site management for Phase I-IV clinical research projects. Your responsibilities will ensure that clinical trials are conducted according to protocols, standard operating procedures (SOPs), ICH-GCP guidelines, and all applicable local and federal regulations.
Key Responsibilities
Site Management: Conduct site qualification, initiation, interim monitoring, and close-out visits (both on-site and remotely) to ensure compliance with regulatory standards and protocols. Use your expertise to assess site performance, recommend actions, and escalate serious issues as necessary.
Informed Consent Verification: Ensure that the informed consent process is thoroughly executed and documented while safeguarding patient confidentiality and assessing factors affecting safety and data integrity.
Monitoring Activities: Execute tasks in line with the Clinical Monitoring/Site Management Plan (CMP/SMP), including:
Investigational Product Oversight: Manage investigational product (IP) inventory, ensuring compliance with protocols for dispensing, labeling, and storage.
Documentation and Reporting: Maintain accurate records through confirmation letters, trip reports, and communication logs, while supporting patient recruitment and data tracking.
Project Coordination: Understand project scope, budgets, and timelines, ensuring site-level communications meet project objectives. Adapt quickly to changing priorities as necessary.
Liaison Role: Act as the primary contact with site personnel, ensuring training and compliance with project requirements.
Meeting Participation: Prepare for and attend Investigator Meetings and project staff meetings, and may lead discussions with supervision.
Audit Readiness: Provide guidance on audit preparedness and support necessary follow-up actions.
Mentorship: May train and mentor junior CRAs, providing guidance and oversight as needed.
Real World Late Phase (RWLP) Responsibilities: When acting as a Senior Site Management Associate I, support sites throughout the study lifecycle, conduct chart abstractions, and collaborate with local teams. Identify operational efficiencies and contribute to bid defense meetings.
Qualifications
Get to Know Syneos Health
In the last five years, we have collaborated on 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products, conducting over 200 studies across 73,000 sites with more than 675,000 trial patients. Join us in a dynamic and competitive environment and make a meaningful impact in the world of clinical research.
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 :
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Coral Gables | Gainesville | Jacksonville | Naples | Orlando | Rueil-Malmaison | Tallahassee | Tampa | West Palm Beach |Georgia :
Atlanta |Hawaii :
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Abbott Park | Champaign | Chicago | Deerfield | Lombard | Naperville | Round Lake |Indiana :
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Lawrence |LA :
Monroe | New Orleans |Maryland :
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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 :
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Mexico |Tennessee :
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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 :
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Montreal |Republic of Colombia :
Bogota |Zagreb :
Zagreb |Republic of Egypt :
Cairo |United Kingdom :
Salt Lake City | London | Harlow |Jakarta :
Jakarta |Republic of Ireland :
Limerick | Dublin |Israel :
Kfar Saba | Tel Aviv | Netanya |Republic of Korea :
Seoul |Capital of Netherland :
Amsterdam |Noord Holland :
Haarlem |Remote :
Remote, USA | Remote - Europe | Switzerland | Remote |Makkah :
Jeddah | Rabigh | Najran | Khulais | Riyadh |Catalonia :
Barcelona |Republic of Thailand :
Bangkok |