About Syneos Health
Syneos Health® is a fully integrated life sciences services organization focused on accelerating customer success across the drug development and commercialization continuum. The company partners with innovators to navigate complexity, anticipate change, and drive progress in healthcare.
Key Highlights
25,000+ global employees
Worked with:
94% of novel FDA-approved drugs (last 5 years)
95% of EMA-authorized products
Experience across:
200+ studies
73,000 sites
675,000+ trial patients
Role Overview
Position: CRA II / Sr. CRA I (Oncology)
Function: Clinical Monitoring / Clinical Research
This role focuses on monitoring clinical trials to ensure compliance with regulatory standards, data integrity, and patient safety. The position requires strong oncology expertise and the ability to manage site activities, both remotely and on-site.
Key Responsibilities
1. Clinical Monitoring & Site Management
Conduct:
Site qualification visits
Site initiation visits
Interim monitoring visits
Close-out visits
Perform both remote and on-site monitoring
Ensure compliance with:
Protocol requirements
Regulatory guidelines
ICH-GCP standards
2. Data Integrity & Compliance
Review source documents and medical records
Verify accuracy and completeness of Case Report Forms (CRFs)
Perform query resolution and ensure timely closure
Ensure compliance with electronic data capture systems
3. Patient Safety & Ethics
Verify proper informed consent process
Protect subject confidentiality
Identify and escalate:
Protocol deviations/violations
Pharmacovigilance issues
Assess risks affecting patient safety and data integrity
4. Investigational Product (IP) Management
Manage IP inventory, storage, and reconciliation
Ensure proper dispensing and administration per protocol
Monitor risks related to blinded/randomized studies
Ensure compliance with labeling, import, and return processes
5. Documentation & Reporting
Maintain:
Investigator Site File (ISF)
Trial Master File (TMF) alignment
Document activities via:
Trip reports
Follow-up letters
Communication logs
Ensure completeness and audit readiness
6. Site Support & Study Execution
Support patient recruitment and retention strategies
Track study progress and action items
Ensure site staff training and compliance
Act as liaison with site personnel and stakeholders
7. Collaboration & Meetings
Attend:
Investigator meetings
Sponsor meetings
Clinical project team meetings
Collaborate with:
Sponsors
Medical Science Liaisons
Local country teams
8. Audit & Quality Readiness
Ensure audit readiness at site and project level
Support audits and follow-up actions
9. Additional Responsibilities
Train junior staff (if required)
Identify out-of-scope activities and escalate
Suggest potential sites based on local insights
Support real-world late-phase studies (if applicable)
Perform chart abstraction and data collection
Qualifications
Education
Bachelor’s degree or Registered Nurse (RN) in a related field
Equivalent combination of education and experience accepted
Experience
5+ years of clinical monitoring experience
Strong oncology experience (mandatory)
Experience with global clinical trials and site management
Technical Knowledge
Good Clinical Practice (GCP)
ICH Guidelines
Regulatory requirements
Clinical trial processes and monitoring plans
Skills & Competencies
Strong communication and interpersonal skills
Good presentation abilities
Proficiency in computer systems and new technologies
Strong analytical and problem-solving skills
Ability to adapt to changing priorities
Travel Requirement
Up to 75% travel required
Role Summary
Clinical Monitoring professionals are responsible for ensuring the integrity and quality of clinical trials. This includes:
Monitoring data and processes
Using risk-based and data-driven approaches
Ensuring compliance with regulatory and clinical standards
Supporting trial success through collaboration and oversight
Work Culture & Benefits
Strong focus on career development and progression
Supportive management and training programs
Inclusive and diverse workplace culture
Recognition and total rewards programs
Purpose-driven mission: “Driven to Deliver”
Additional Information
Responsibilities may evolve based on business needs
Equivalent qualifications and experience may be considered
Committed to global employment regulations and diversity standards
Provides reasonable accommodations where required
Call to Action
Apply directly or join the Talent Network to explore future opportunities
Uttar Pradesh :
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Delhi | India | New Delhi | PAN-India |Assam :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | Mount Arlington | Newark | New Brunswick | 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 | Westfield | West Orange | Wharton | Whippany |Ohio :
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Baton Rouge | Monroe | New Orleans |Washington :
Bellevue | Bothell | Friday Harbor | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Tacoma | Vancouver |Oregon :
Bend | Coquille | Corvallis | Eugene | Florence | Grants Pass | John Day | Lake Oswego | Lakeview | Portland | Reedsport | Roseburg | Salem | Springfield | Woodburn |Wyoming :
Big Piney | Cokeville |Alabama :
Birmingham |Virginia :
Blacksburg | Charlottesville | Falls Church | Mechanicsville |Indiana :
Bloomington | West Lafayette |Florida :
Boca Raton | Brooksville | Clearwater | Cooper City | Coral Gables | Coral Springs | Daytona Beach | Florida | Gainesville | Hollywood | Jacksonville | Maitland | Marsa | Miami | Naples | North Miami Beach | Orlando | Pembroke Pines | Plantation | Port St. Lucie | Rueil-Malmaison | Saint Petersburg | Sarasota | Stuart | Tallahassee | Tampa | West Palm Beach | Winter Haven |Idaho :
Boise |Colorado :
Boulder | Denver | Westminster |Connecticut :
Bridgeport | Bristol | Enfield | Groton | Hartford | New Haven | Newtown | South Windsor | Stamford | Storrs | West Hartford |North Caroline :
Carolina Beach | Chapel Hills | Durham | Holly Springs | Morrisville | Philippines | Raleigh | Rocky Mount | Sanford | Scottsdale |Arizona :
Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |South Carolina :
Charleston |Kansas :
Chengdu | Garden city | Kansas City | Lawrence | McPherson |North Carolina :
Concord | Lumberton | North Carolina |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
Edgewood | Ft MItchell | Louisville | Shelbyville |Arkansas :
Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
Hebron | Nebraska City |Hawaii :
Hilo | Honolulu |Tennessee :
Knoxville | Memphis | Nashville |Louisiana :
Lake Charles | Shreveport |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
Lebanon | Macon | Manchester |Portugal :
Lisbon | Oeiras | Portugal |WI :
Madison | Wausau |Republic of Mexico :
Mexico |northeastern :
New Hampshire |Oklahoma :
Oklahoma City |Puerto Rico :
San Juan |Albama :
Tuscaloosa |D.C :
Washington |Delaware :
Wilmington |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Munich :
Bavaria |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
Gottingen | Hannover | Leipzig |Saxony Anhalt :
Halle |Rotherbaum :
Hamburg |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Schleswig Holstein :
Kiel |Berlin :
Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
Ballydine |Cork :
Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
Breda |Noord Holland :
Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Uxbridge | Australia | North York | Renfrew | Mississauga | Richmond Hill |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Sao paulo | Brazil |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
Almaty |Republic of Thailand :
Bangkok |Israel :
Kfar Saba | Tel Aviv | Yavne | Be'Er Sheva | Netanya |Remote :
Medan | Riga | Remote - Europe | Zaragoza | Castlebar | Green Way | Lenexa | Thailand | Regulatory Labeling Manager (NA and LATAM Only) | Remote | Minnesota | Bishop | Ireland | Belgium | Remote, USA | Slovakia | Melbourne | Hungary | Remote - Middle East | Manipal | Lousiana | Xzagreb | Leinster | Blue Bell | Bountiful | Victoria | McFarland | Texas | Hammond | Nairobi | Switzerland | French | Remote - Africa | Tulsa | Faridabad | Remote - South America (Latin Americal) | Springville |Republic of Colombia :
Bogota |Williamson :
Brentwood |Bucharest :
Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
Cairo |Mexico :
New Mexico | Ciudad de México |Dubai :
Dubai |Makkah :
Rabigh | Khulais | King Abdullah Economic City | Najran | Riyadh | Jeddah |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
Sweden |Taipei :
Taipei |Mazovia :
Warsaw |
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