Clinical Research Associate

2+ years

Not Disclosed

Mumbai

10 Jan. 15, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Clinical Research Associate

Job ID: REQ-10036180
Location: Mumbai, India
Posted on: January 14, 2025
Employment Type: Full-time, Regular

Role Summary:

As a Clinical Research Associate (CRA), you will manage site relationships to ensure sustainable trial execution. This includes performing on-site and remote monitoring activities for Phase I-IV Global Drug Development (GDD) trials while adhering to International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)/Good Clinical Practice (GCP), local regulations, and Standard Operating Procedures (SOPs).

Key Responsibilities:

Act as the primary liaison between Novartis and study sites, ensuring successful collaboration and deliverables.
Manage assigned study sites and oversee Phase I-IV protocols per Monitoring Plan and company procedures.
Conduct Site Initiation Visits, training site personnel on all trial-related aspects, and provide ongoing re-training as needed.
Perform continuous site monitoring activities (on-site and remote), ensuring compliance with protocols, regulations, and company standards.
Advocate for adherence to ethical and compliance standards, emphasizing human subject protection and trial result reliability.
Execute Site Closeout activities in accordance with SOPs and regulations, including follow-up and archiving requirements.
Collaborate with Site & Study Operations (SSO) Clinical Project Managers, CRA Managers, and other team members to optimize recruitment, site development, and data quality.
Participate in audit preparation and inspection readiness activities for site-related tasks.

Role Requirements:

Minimum Requirements:
- Degree in a scientific or healthcare discipline.
- At least 2 years of pharmaceutical industry experience or relevant field experience.
- Experience with central/in-house or field monitoring.
- Knowledge of international standards such as GCP/ICH, FDA, and EMA.
- Understanding of CRA responsibilities including patient safety, data integrity, PI oversight, and compliance.

Why Novartis?

Novartis strives to reimagine medicine and improve lives, driven by a vision to become the most valued and trusted medicines company in the world. This mission is supported by a community of passionate and innovative individuals who work together to achieve breakthroughs that change lives.

What We Offer:

Comprehensive benefits outlined in the Novartis Life Handbook.
A culture of diversity and inclusion that values professional growth and collaboration.
Opportunities to work with and learn from driven, like-minded individuals.

Commitment to Diversity and Inclusion

Novartis is dedicated to fostering an inclusive work environment that reflects the diverse communities and patients we serve.

Accessibility:
For reasonable accommodations due to medical conditions or disabilities, contact diversityandincl.india@novartis.com with the job requisition number and your details.

Join the Novartis Network:

Not the right role? Stay connected by joining the Novartis Talent Network for updates on future opportunities.

Division: Development
Business Unit: Innovative Medicines
Functional Area: Research & Development
Location: Mumbai (Head Office)
Company/Legal Entity: Novartis Healthcare Private Limited

Ready to create a brighter future together? Apply Now

Latest Jobs

Asst/Assoc/Full Professor Of Clinical Geo, Department Of Internal Medicine, Division Of Rheumatology

Cincinnati Children's Hospital

Cincinnati

Inpatient Pharmacist

Dayton Children's Hospital

Lebanon

Business Manager / Business Administrator, Division Of Hematology/Oncology

Cincinnati Children's Hospital

Cincinnati

Pharmacist - Outpatient

Dayton Children's Hospital

Franklin

Specialty Pharmacy Oncology Clinical Pharmacist

St. Elizabeth Physicians

Edgewood

Associate Consultant - Fmso - Goso

Lilly

Bangalore

Drug Safety Specialist

Barrington James

Remote

Pharma Jobs in India

Andra Pradesh :

Assam :

Dibrugarh | Diburghar | Guwahati |

Bihar :

Hajipur | Patna |

Chhattisgarh :

Bilaspur | Eot Municipality | Raipur |

Delhi :

Delhi | India | New Delhi | PAN-India |

Goa :

Goa | Panaji | Verna |

Gujarat :

Haryana :

Himachal Pradesh :

Baddi | Solan |

India :

Siliguri |

Jharkhand :

Ranchi |

Karnataka :

Kerala :

Madhya Pradesh :

Maharashtra :

Odisha :

Bhubaneswar | Rourkela |

PAN-India :

Panjab :

Punjab :

Rajasthan :

Sikkim :

Rangpo |

Tamil Nadu :

Uttar Pradesh :

Uttarakhand :

Dehradun | Nainital | Rishikesh |

West Bengal :

Digha | Kolkata | Mukundapur |

Pharma Jobs in United States

Alabama :

Birmingham |

Alaska :

Albama :

Tuscaloosa |

Arizona :

Arkansas :

Fort Smith |

California :

Colorado :

Boulder | Denver | Westminster |

Connecticut :

D.C :

Washington |

Delaware :

Wilmington |

Florida :

Georgia :

Atlanta | Rome |

Hawaii :

Hilo | Honolulu |

Idaho :

Boise |

Illinois :

Indiana :

Bloomington | West Lafayette |

Kansas :

Garden city | Kansas City | Lawrence | McPherson |

Kentucky :

Edgewood | Ft MItchell | Louisville | Shelbyville |

Kington :

Frank Scottile Blvd |

LA :

Baton Rouge | Monroe | New Orleans |

Louisiana :

Lake Charles | Shreveport |

Maine :

Bangor | Brewer |

Maryland :

Massachusetts :

Michigan :

Detroit | Houghton Lake |

Minnesota :

Missouri :

Fulton | Milan | St. Louis |

Nebraska :

Hebron | Nebraska City |

Nevada :

Las Vegas | Tonopah | Tonopsh |

New Hampshire :

Lebanon | Manchester |

New Jersey :

New Mexico :

Farmington | Santa Fe | Tucumcari |

New York :

North Carolina :

Concord | Lumberton | North Carolina |

North Caroline :

North Dakota :

Dickinson |

northeastern :

New Hampshire |

Ohio :

Oklahoma :

Oklahoma City |

Oregon :

Pennsylvania :

Portugal :

Lisbon | Portugal |

Puerto Rico :

San Juan |

Republic of Mexico :

Mexico |

South Carolina :

Charleston |

Tennessee :

Memphis | Nashville |

Texas :

United states :

fairmont | Georgia | United States |

United States :

Hawai | Sylmar |

Virginia :

Blacksburg | Charlottesville | Falls Church |

Washington :

WI :

Madison | Wausau |

Wisconsin :

Portage |

Wyoming :

Big Piney | Cokeville |

Pharma Jobs in Germany

Baden-Wurttemberg :

Bavaria :

Berlin :

Mitte |

Brandenburg :

Berlin |

Germany :

Germany | GErmany |

Hesse :

Darmstadt | Marburg |

Hessen :

Frankfurt | Harveysburg |

Lower Saxony :

Gottingen | Hannover | Leipzig |

Mecklenburg Vorpommern :

Rostock |

Munich :

Bavaria |

North Rhine Westphalia :

Rhineland Palatinate :

Ingelheim am Rhein | Mainz |

Rotherbaum :

Hamburg |

Saarland :

Saarbrucken |

Saxony Anhalt :

Halle |

Schleswig Holstein :

Kiel |

Pharma Jobs in Europe

BULGARIA :

Bulgaria |

Denmark :

Copenhagen | Denmark |

Europe :

Latvia | Leuven | Poland | Spain |

Finland :

Finland |

Hungary :

Budapest |

Istanbul :

Istanbul | Turkey |

Norway :

Norway | NOrway |

Romania :

Romania |

Serbia :

Belgrade | Serbia |

Switzerland :

Basel | Zurich |

Pharma Jobs in China

China :

China |

Hubei :

Wuhan |

Liaoning :

Dalian |

Republic of China :

Beijing |

Shanghai Sai :

Shanghai Shi |

Tokiyo :

Osaka | Tokyo |

Zhejiang :

Hangzhou |

Pharma Jobs in Australia

Melbourne :

South Yarra |

New South Wales :

Ballina | Sydney |

Queensland :

Queensland |

Remote Australia :

Remote Australia |

Republic of Western Australia :

Nedlands |

Pharma Jobs in Ireland

Cork :

Ringaskiddy |

County Dublin :

Swords |

Dún Laoghaire :

Dún Laoghaire |

Republic of Ireland :

Dublin | Limerick | Waterford |

Ulster :

Donegal |

Pharma Jobs in Netherland

Capital of Netherland :

Amsterdam |

Netherlands :

Netherlands |

Noord Holland :

Haarlem |

North Brabant :

Breda |

South Holland :

Leiden |

Pharma Jobs in United Kingdom

Antrim :

Larne |

Cheshire :

Runcorn |

Hertfordshire :

Welwyn |

Surrey :

Pirbright |

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

Buenos Aires :

Buenos Aires |

Austria :

Austria |

Vienna :

Vienna |

Antwerp :

Heist op den Berg |

Brussels :

Brussels |

Bosnia and Herzegovina :

Sarajevo |

Sofia City :

Sofia |

Canada :

Canada |

Ontario :

Quebec :

Montreal |

Chile :

Santiago |

Republic of Colombia :

Bogota |

Croatia :

Croatia |

Zagreb :

Zagreb |

Bohemia :

Prague |

Republic of Egypt :

Cairo |

South Yorkshire :

Sheffield |

United Kingdom :

Estonia :

Tartu | Estonia |

Harju County (Maakond) :

Tallinn |

Chuuk :

North Ostrobothnia :

Oulu |

Southwest Finland (Varsinais-Suomi) :

Turku |

France :

Lyon | Paris |

Attica :

Athens | Koropi |

Greece :

Greece |

East Java :

Surabaya |

Jakarta :

Jakarta |

Israel :

Italy :

Italy |

Lombardy :

Rho |

Japan :

Japan |

Tokyo :

Otemachi |

Kazakhstan :

Almaty |

Remote Korea :

Remote Korea |

Republic of Korea :

Seoul |

Kuala Lumpur :

Kuala Lumpur |

Mexico :

Ciudad de México |

Lima Region :

Lima |

Cebu Province :

Cebu City |

Philippines :

Manila |

Mazovia :

Warsaw |

Remote :

Bucharest :

Bucharest |

Makkah :

Nišava District :

Niš |

Singapore :

Singapore |

South Africa :

Midrand |

Brazil :

Sao paulo |

South America :

Argentina |

Catalonia :

Barcelona |

Madrid :

Madrid |

Sweden :

Sweden |

Taipei :

Taipei |

Williamson :

Brentwood |

Republic of Thailand :

Bangkok |

Kyiv Oblast :

Kyiv |

Dubai :

Dubai |

Hà Nội :

Hanoi | Hà Nội |

Ho Chi Minh :

Ho Chi Minh City |

Clinical Research Associate

Job Description

Clinical Research Associate

Role Summary:

Key Responsibilities:

Role Requirements:

Why Novartis?

Commitment to Diversity and Inclusion

Join the Novartis Network:

Latest Jobs

Pharmacist-Critical Care/Or

Pharmacist

Pharmacist

Asst/Assoc/Full Professor Of Clinical Geo, Department Of Internal Medicine, Division Of Rheumatology

Inpatient Pharmacist

Business Manager / Business Administrator, Division Of Hematology/Oncology

Pharmacist - Outpatient

Specialty Pharmacy Oncology Clinical Pharmacist

Associate Consultant - Fmso - Goso

Drug Safety Specialist

Pharma Jobs in India

Pharma Jobs in United States

Pharma Jobs in Germany

Pharma Jobs in Europe

Pharma Jobs in China

Pharma Jobs in Australia

Pharma Jobs in Ireland

Pharma Jobs in Netherland

Pharma Jobs in United Kingdom