Senior Clinical Research Associate I
Location: Home-Based
Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization committed to accelerating customer success. We transform clinical, medical affairs, and commercial insights into impactful outcomes, tackling the challenges of today’s healthcare environment.
Our Clinical Development model centers on the customer and the patient. We continually strive to simplify processes, ensuring Syneos Health is not only easier to work with, but also a better place to work for our team members. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll work with passionate individuals, innovating as a team to help our customers achieve their goals. We are driven to deliver therapies faster because we are dedicated to improving lives.
At Syneos Health, we’re committed to developing our people through career growth, supportive management, technical and therapeutic training, and peer recognition. Our Total Self culture fosters authenticity and inclusivity, uniting us across countries, and helping to build a workplace where everyone feels valued.
Site Management & Monitoring:
Conduct site qualification, initiation, interim monitoring, and close-out visits (on-site or remotely), ensuring compliance with regulatory standards, ICH-GCP, GPP, and protocol. Use judgment to evaluate site performance and escalate critical issues to the project team, developing corrective action plans.
Informed Consent & Patient Safety:
Verify that informed consent is obtained and documented for each subject/patient as required. Safeguard patient confidentiality and assess factors affecting patient safety and data integrity, addressing protocol violations or pharmacovigilance issues.
Data Review & Compliance:
Perform Source Document Reviews, ensuring data accuracy in case report forms (CRFs) and resolving data queries within agreed timelines. Ensure site compliance with data capture and reporting requirements.
Investigational Product (IP) Management:
Oversee IP inventory, reconciliation, security, and dispensation. Verify IP handling, labeling, and storage procedures, ensuring compliance with blinded or randomized information protocols.
Documentation & Reporting:
Maintain timely and accurate documentation such as confirmation letters, trip reports, and communication logs. Track project observations, actions, and outcomes to resolution.
Project Coordination:
Ensure the achievement of project timelines and objectives by managing site-level communication and activities. Adapt to changing priorities to meet goals.
Liaison & Training:
Act as the primary liaison for site personnel, ensuring that training and compliance are met. Attend Investigator Meetings, sponsor meetings, and clinical training sessions.
Audit Readiness & Compliance:
Assist sites in meeting audit standards and help with preparation for audits and follow-up actions.
Mentorship & Leadership:
Provide training and mentorship to junior CRAs and may assist with training and sign-off visits for junior staff. May also assist in clinical operations lead tasks under supervision.
Real World Late Phase (RWLP) Responsibilities:
Support sites throughout the study lifecycle. Contribute to data collection and chart abstraction activities. Work closely with affiliates, medical science liaisons, and local staff to improve study efficiency.
Additional RWLP duties include:
Over the past five years, Syneos Health has partnered with 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products, conducting over 200 studies across 73,000 sites, involving over 675,000 trial patients.
At Syneos Health, you'll take initiative to challenge the status quo in a dynamic, fast-paced environment. Your contributions will make a meaningful impact in global healthcare.
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 :
Groton | Storrs |D.C :
Washington |Florida :
Clearwater | 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 | Gaithersburg | Rockville |Massachusetts :
Boston | Cambridge | Devens | Medford and Somerville | Rockland |Michigan :
Detroit |Minnesota :
Minneapolis and St. Paul, Minnesota. |Missouri :
Fulton | St. Louis |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | 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 :
Cincinnati | Cleveland | 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 |Germany :
Germany | GErmany |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 |Romania :
Romania |Serbia :
Belgrade |Switzerland :
Basel | Zurich |Hubei :
Wuhan |Republic of China :
Beijing |Shanghai Sai :
Shanghai Shi |Tokiyo :
Osaka | Tokyo |Buenos Aires :
Buenos Aires |New South Wales :
Sydney |Queensland :
Queensland |Republic of Western Australia :
Nedlands |Ontario :
North York | Richmond Hill |Quebec :
Montreal |Republic of Colombia :
Bogota |Zagreb :
Zagreb |Republic of Egypt :
Cairo |United Kingdom :
Salt Lake City | Harlow | London |Jakarta :
Jakarta |County Dublin :
Swords |Republic of Ireland :
Waterford | Limerick | Dublin |Israel :
Netanya | Kfar Saba | Be'Er Sheva | Tel Aviv |Tokyo :
Otemachi |Republic of Korea :
Seoul |Capital of Netherland :
Amsterdam |Noord Holland :
Haarlem |Remote :
Remote, USA | Remote - Europe | Remote | Switzerland |Makkah :
Khulais | Riyadh | Najran | Rabigh | Jeddah |Catalonia :
Barcelona |Republic of Thailand :
Bangkok |