Job Title
Clinical Research Associate II (CRA II)
Company
Fortrea
Location
Bangalore, India
Employment Type
Full-time / Clinical Operations
Role Overview
The Clinical Research Associate II (CRA II) is responsible for independent site monitoring and clinical trial oversight across assigned studies. The role ensures patient safety, protocol compliance, and data integrity through on-site and remote monitoring activities in accordance with ICH-GCP guidelines, local regulations, and sponsor requirements.
This position supports full lifecycle site management, including pre-study, site initiation, routine monitoring, and close-out visits, with increasing responsibility for leadership tasks such as acting as Lead CRA when assigned.
Key Responsibilities
1. Site Monitoring & Management
Conduct all types of monitoring visits:
Pre-study visits
Site Initiation Visits (SIV)
Routine monitoring visits
Close-out visits
Ensure compliance with:
Study protocol
ICH-GCP guidelines
Fortrea SOPs
Sponsor requirements
2. Patient Safety & Protocol Compliance
Verify informed consent process is properly conducted
Ensure eligibility criteria and protocol adherence
Protect subject safety throughout study conduct
Track and follow up on Serious Adverse Events (SAEs)
3. Data Integrity & Source Verification
Perform Source Document Review (SDR) and Source Data Verification (SDV)
Identify missing, inconsistent, or incorrect data
Generate and resolve data queries in clinical systems
Ensure accuracy, completeness, and consistency of clinical trial data
4. Regulatory & Study Documentation
Ensure Investigator Site Files (ISF) and eTMF documents are complete and up to date
Verify site regulatory compliance throughout the study lifecycle
Maintain inspection and audit readiness at site level
5. Investigational Product (IP) Management
Monitor IP accountability and inventory
Ensure proper storage, dispensing, and reconciliation per protocol
Track shipments and study supplies as needed
6. Reporting & Communication
Prepare timely and accurate trip reports after site visits
Participate in:
Investigator meetings
Project team meetings
Teleconferences
Communicate site status and risks to study teams
7. Study Support Activities
Assist with site selection and investigator recruitment (if applicable)
Support preparation of monitoring plans and SIV materials
Contribute to training of site staff and new CRA team members
Perform co-monitoring and mentoring tasks when required
8. System & Process Management
Use clinical trial systems such as:
CTMS (Clinical Trial Management Systems)
eCRF platforms
eTMF systems
Maintain accurate tracking of study activities and documentation
Required Qualifications
Education
University or college degree in:
Life Sciences
Nursing
Allied health profession
OR equivalent clinical research experience
Experience
Minimum 2 years of clinical monitoring experience (CRA or equivalent role)
Experience in independent site monitoring is required
Knowledge of clinical trial processes and documentation
Required Skills & Competencies
Clinical Research Skills
Strong understanding of:
ICH-GCP guidelines
Clinical trial monitoring processes
Regulatory requirements
Experience with SAE reporting and follow-up
Analytical & Operational Skills
Strong attention to detail
Ability to identify and resolve protocol deviations
Problem-solving and decision-making ability
Ability to manage multiple sites and timelines
Communication Skills
Strong verbal and written communication skills
Ability to work in global, matrix environments
Effective interaction with investigators and site staff
Work Style
Independent working ability with minimal supervision
Strong organizational and planning skills
Ability to travel extensively (~60%)
Ability to work under pressure and meet deadlines
Preferred Qualifications
Phase I monitoring experience
Life sciences or nursing background
Familiarity with Fortrea SOPs and systems
Exposure to medical devices or pharmacology concepts (if applicable)
Work Environment
Combination of office, remote, and hospital/site visits
High travel requirement (~60%)
Exposure to clinical and investigator site environments
Risk of extended computer-based work (data review, reporting)
Company Overview
Fortrea is a global Contract Research Organization (CRO) specializing in clinical development and trial management services across multiple therapeutic areas. The company focuses on delivering high-quality clinical research solutions while maintaining regulatory compliance and patient safety standards.
Role Summary
The CRA II role at Fortrea involves independent clinical site monitoring, ensuring compliance, patient safety, and data integrity across global clinical trials. The position requires strong clinical research knowledge, regulatory expertise, and the ability to manage multiple investigator sites while maintaining high-quality monitoring standards.
Uttar Pradesh :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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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 :
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Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
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Hebron | Nebraska City |Hawaii :
Hilo | Honolulu |Tennessee :
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Madison | Wausau |Republic of Mexico :
Mexico |northeastern :
New Hampshire |Oklahoma :
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Washington |Delaware :
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Mitte |Mecklenburg Vorpommern :
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Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
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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 :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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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 :
Mississauga | Uxbridge | North York | Australia | Richmond Hill | Renfrew |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 :
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Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
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Italy |Lombardy :
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Jakarta |East Java :
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Saitama | Japan |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
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Bangkok |Israel :
Kfar Saba | Netanya | Tel Aviv | Be'Er Sheva | Yavne |Remote :
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Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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Sofia |Sweden :
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Taipei |Mazovia :
Warsaw |
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