Cra Ii/ Sr Cra I (Mumbai Location, Client Based) (Oncology)

Syneos Health

0-2 years

Not Disclosed

India

10 Oct. 4, 2025

Job Description

Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

🧑‍💼 Position Title:

CRA II / Sr CRA I (Oncology, Mumbai – Client-based)

🌍 Location:

Mumbai, India (Client-based)

🆔 Job ID:

25101933

🎯 Job Overview:

Responsible for monitoring clinical trial sites in Oncology (and related therapeutic areas) to ensure compliance with regulatory requirements, ICH-GCP, and protocol guidelines. Supports site initiation, monitoring, and close-out activities, while maintaining data integrity, patient safety, and regulatory adherence.

🌟 Key Responsibilities:

🔹 Site Management & Monitoring

Conduct site qualification, initiation, interim monitoring, management, and close-out visits (on-site or remote).
Evaluate site performance and staff; escalate serious issues and develop action plans.
Verify informed consent, confidentiality, and protocol compliance for subjects/patients.
Assess factors affecting patient safety and clinical data integrity (protocol deviations, pharmacovigilance issues).
Source Document Review (SDR) and verification of clinical data entered in CRFs.
Apply query resolution techniques remotely and on-site.

🔹 Investigational Product (IP) Oversight

Monitor IP inventory, reconciliation, storage, and security.
Ensure IP dispensation and administration per protocol.
Verify blinded/randomized IP processes and regulatory compliance.

🔹 Documentation & Compliance

Review and maintain Investigator Site File (ISF) for accuracy and completeness; reconcile with Trial Master File (TMF).
Document activities via trip reports, confirmation/follow-up letters, communication logs.
Support patient recruitment, retention, and awareness strategies.
Track site observations, statuses, and action items using tracking systems.
Ensure audit readiness and support sponsor/internal audits.

🔹 Collaboration & Training

Act as liaison with site personnel and Central Monitoring Associate.
Train junior staff and provide guidance on project-specific requirements.
Attend investigator meetings, sponsor meetings, and clinical monitoring project staff meetings.
Support Real World Late Phase studies: site identification, chart abstraction, and local requirements.
Collaborate with sponsor affiliates, medical science liaisons, and local staff.

🔹 Project Management & Reporting

Manage site-level activities to meet project scope, budgets, timelines, and deliverables.
Identify and communicate out-of-scope activities to Lead CRA/Project Manager.
Suggest potential sites based on local treatment patterns and patient advocacy networks.

🎓 Qualifications & Requirements:

Bachelor’s degree or RN in a related field (or equivalent education/experience).
Minimum 3–5 years of clinical monitoring experience.
Experience in Oncology, Hematology, Cardiology, Neuropsychiatry, Rare Diseases, or Immunology.
Pharma industry background.
Knowledge of ICH/GCP guidelines and applicable regulatory requirements.
Proficient in computer skills; comfortable with new technologies.
Excellent communication, presentation, and interpersonal skills.
Ability to manage up to 75% travel regularly.
US-only compliance note: provide personal/medical info if required for site access.

🌐 Why Syneos Health:

Inclusive Total Self culture promoting diversity, belonging, and professional growth.
Work across 29,000 employees in 110 countries.
Participate in FDA-approved and EMA-authorized studies.

📌 Summary:

CRA II / Sr CRA I monitors clinical trial sites to ensure compliance with regulatory, protocol, and GCP requirements. Supports site initiation, management, and close-out, oversees IP handling, provides guidance to site teams, and contributes to audit readiness. Acts as a key liaison between sites, sponsors, and project teams while mentoring junior staff and enhancing trial quality through proactive monitoring and reporting.

Recommended Jobs

Pharma Jobs in India

Gujarat :

Maharashtra :

Haryana :

Andra Pradesh :

Tamil Nadu :

Himachal Pradesh :

Baddi | Solan |

Rajasthan :

Karnataka :

Punjab :

Madhya Pradesh :

Odisha :

Bhubaneswar | Rourkela |

Chhattisgarh :

Bilaspur | Eot Municipality | Raipur |

Uttarakhand :

Delhi :

Delhi | India | New Delhi | PAN-India |

Assam :

Dibrugarh | Diburghar | Guwahati |

West Bengal :

Digha | Kolkata | Mukundapur |

Uttar Pradesh :

Goa :

Goa | Panaji | Verna |

Bihar :

Hajipur | Patna |

Kerala :

Pondicherry (Puducherry) :

Pondicherry (Puducherry) |

Jharkhand :

Ranchi |

Sikkim :

Rangpo |

India :

Siliguri |

Pharma Jobs in United States

Illinois :

Maryland :

Texas :

California :

New York :

New Mexico :

Albuquerque | Farmington | Santa Fe | Tucumcari |

Pennsylvania :

Alaska :

Massachusetts :

Wisconsin :

United states :

Georgia :

Atlanta | Augusta | Rome |

Maine :

Bangor | Brewer |

New Jersey :

Ohio :

LA :

Baton Rouge | Monroe | New Orleans |

Washington :

Oregon :

Wyoming :

Big Piney | Cokeville |

Alabama :

Birmingham |

Virginia :

Blacksburg | Charlottesville | Falls Church | Mechanicsville |

Indiana :

Bloomington | West Lafayette |

Florida :

Idaho :

Boise |

Colorado :

Boulder | Denver | Westminster |

Connecticut :

North Caroline :

Arizona :

South Carolina :

Charleston |

Kansas :

North Carolina :

Concord | Lumberton | North Carolina |

Michigan :

Detroit | Houghton Lake | Macomb | Southfield |

North Dakota :

Dickinson |

Minnesota :

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 |

Pharma Jobs in Germany

North Rhine Westphalia :

Munich :

Bavaria |

Bavaria :

Brandenburg :

Berlin |

Baden-Wurttemberg :

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 |

Pharma Jobs in Europe

Switzerland :

Basel | Zurich |

Serbia :

Belgrade | Serbia |

Hungary :

Budapest |

BULGARIA :

Bulgaria | Vedant |

Denmark :

Copenhagen | Denmark |

Europe :

Finland :

Finland |

Istanbul :

Istanbul | Turkey |

Norway :

Norway | NOrway |

Romania :

Romania |

Belgium :

Wavre |

Pharma Jobs in Ireland

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 |

Pharma Jobs in China

Republic of China :

Beijing |

China :

China | Quarry Bay |

Liaoning :

Dalian |

Zhejiang :

Hangzhou |

Tokiyo :

Osaka | Tokyo |

Shanghai Sai :

Shanghai Shi |

Hubei :

Wuhan |

Pharma Jobs in Netherland

Capital of Netherland :

Amsterdam |

North Brabant :

Breda |

Noord Holland :

Haarlem |

South Holland :

Leiden |

Netherlands :

Netherlands |

Pharma Jobs in Australia

Remote Australia :

Arkansas | Remote Australia |

New South Wales :

Ballina | Sydney |

Republic of Western Australia :

Nedlands |

Queensland :

Queensland |

Melbourne :

South Yarra |

Pharma Jobs in United Kingdom

Surrey :

Chessington | Pirbright |

Antrim :

Larne |

Cheshire :

Runcorn |

Hertfordshire :

Welwyn |

Pharma Jobs in England

United Kingdom :

North Yorkshire :

Harrogate |

South Yorkshire :

Sheffield |

Oxfordshire :

Witney |

Pharma Jobs in Canada & Belgium & South America & Greece & New Zealand & Austria & Spain & Philippines & Croatia & Estonia & Vietnam & Italy & Indonesia & Japan & Finland & Korea & Kazakhstan & Thailand & Israel & Remote & Colombia & Tennessee & Romania & Argentina & Egypt & Mexico & United Arab Emirates & Saudi Arabia & malaysia & Ukraine & Peru & France & South Afrcia & Serbia & Czechia & Chile & Bosnia and Herzegovina & Singapore & Bulgaria & Sweden & Taiwan & Poland

Ontario :

Canada :

Canada |

Quebec :

Montreal |

Brussels :

Brussels |

Antwerp :

Heist op den Berg |

Flemish Brabant :

Zaventem |

South America :

Argentina | Peru |

Brazil :

Sao paulo | Brazil |

Attica :

Koropi | Athens |

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 :

Hà Nội | Hanoi |

Ho Chi Minh :

Ho Chi Minh City |

Italy :

Italy |

Lombardy :

Rho |

Jakarta :

Jakarta |

East Java :

Surabaya |

Japan :

Saitama | Japan |

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 :

Remote :

Republic of Colombia :

Bogota |

Williamson :

Brentwood |

Bucharest :

Bucharest |

Buenos Aires :

Buenos Aires |

Republic of Egypt :

Cairo |

Mexico :

Ciudad de México | New Mexico |

Dubai :

Dubai |

Makkah :

Kuala Lumpur :

Kuala Lumpur |

Kyiv Oblast :

Kyiv |

Lima Region :

Lima |

France :

Paris | Lyon |

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 |

Welcome Back

Create Account

Cra Ii/ Sr Cra I (Mumbai Location, Client Based) (Oncology)

Job Description

Recommended Jobs

Site Contract Specialist (Hyderabad)

Analyst -Reporting Solutions

Principal Statistician

Irt Clinical Supplies Specialist - Operations

Insurance Verification Representative

Officer

Ctt Specialist - I (Post Graduates - 2026 Passouts)

Cra (Level I, Level Ii And Sr Cra)

Centralized Study Spec I

Clinical Data Review Associate (Mumbai) - Entry/ Experienced Nurses Wanted