Job Title
Initiation Clinical Research Associate I (iCRA I)
Company
Parexel
Location
Bengaluru, India
Employment Type
Clinical Research / Full-time
Role Overview
The Initiation Clinical Research Associate I (iCRA I) is responsible for managing and driving clinical trial startup, Pre-SIV (Site Initiation Visit), and site activation activities. The role acts as a primary point of contact for investigator sites during the startup phase and supports regulatory submissions, site readiness, documentation management, and study activation processes.
The iCRA ensures compliance with ICH-GCP, local regulations, sponsor requirements, and Parexel SOPs while supporting efficient study startup and maintenance activities from site identification through study closeout.
Key Responsibilities
1. Study Startup & Site Activation
(From Site Identification through Site Activation)
Site Management & Communication
Serve as Parexel’s primary contact for assigned sites during startup
Build and maintain relationships with:
Investigators
Site staff
Study stakeholders
Support country-specific feasibility and site qualification activities
Regulatory & Startup Documentation
Prepare, negotiate, and facilitate:
Confidentiality Agreements (CDAs)
Clinical Site Agreements (CSAs)
Regulatory documents
Configure, collect, review, and approve:
Site Greenlight documents
Essential regulatory documentation
Site SIV readiness documentation
Informed Consent Form (ICF) Management
Customize and review country/site-specific ICFs
Coordinate translations and amendment reviews
Ensure compliance with:
Local regulations
Sponsor requirements
Country-specific guidelines
IRB/IEC & Regulatory Submissions
Prepare and submit applications to:
IRB/IEC
Ministry of Health (MoH)
Regulatory Authorities (RA)
Resolve submission issues and manage follow-up until final approvals are received
TMF & CTMS Management
Submit all study documentation to:
Trial Master File (TMF)
Clinical Trial Management Systems (CTMS)
Ensure:
First Time Quality (FTQ)
Timely documentation updates
Accurate clinical system entries
Startup Planning & Risk Management
Forecast and manage:
Site activation timelines
Regulatory approval plans
Startup strategies
Identify and escalate risks related to:
Activation delays
Recruitment issues
Training deficiencies
Data quality concerns
Protocol non-compliance
Study Systems & Training
Support site access to study systems
Ensure completion of required training before study start
Facilitate compliance with project-specific system requirements
2. Study Maintenance Activities
(From Initiation through Closeout)
Support ongoing ICF updates and amendments
Prepare and submit additional IRB/IEC and regulatory applications
Maintain ongoing regulatory approvals and documentation
Ensure timely submission of updated documents to TMF
3. End-to-End Site Management
(From Site Identification through Closeout)
Clinical Systems & Documentation
Maintain and review data in:
CTMS
Site Information Systems (SIS)
eTMF systems
Ensure:
High-quality data entry
Ongoing document maintenance
Inspection readiness
Compliance & Quality
Ensure compliance with:
ICH-GCP
International and local regulations
Parexel SOPs
Sponsor procedures
Maintain audit and inspection readiness for assigned sites
Project Coordination
Collaborate with cross-functional teams to meet project goals
Support project planning and efficient delivery
Ensure understanding of:
Study milestones
Timelines
Budgets
Deliverables
Teamwork & Leadership
Work effectively within global and matrix teams
Support team collaboration and performance culture
Act as mentor and role model where appropriate
Required Skills
Clinical Research & Startup Skills
Strong understanding of:
Clinical trial startup processes
Site activation
Regulatory submissions
Clinical trial documentation
Knowledge of:
CTMS
eTMF
Clinical systems
MS Office tools
Problem-Solving & Decision-Making
Strong analytical and problem-solving skills
Ability to make decisions in ambiguous situations
Ability to prioritize multiple tasks and timelines independently
Communication & Collaboration
Excellent:
Written communication
Verbal communication
Presentation skills
Ability to work across cultures and global teams
Client-focused communication approach
Work Style & Professional Skills
Self-driven and proactive work style
Attention to detail
Strong time management skills
Ability to work effectively in virtual team environments
Flexible and adaptable to changing priorities
Required Experience
Substantial startup experience or equivalent clinical research experience
Understanding of:
Clinical trial methodology
Regulatory requirements
Clinical trial terminology
Educational Requirements
Degree in:
Biological Sciences
Pharmacy
Health-related discipline
OR equivalent nursing qualification
OR equivalent relevant experience
Success Profile
Ideal candidates demonstrate:
Communication skills
Attention to detail
Organizational ability
Problem-solving mindset
Flexibility and adaptability
Self-motivation and accountability
Work Environment
Global clinical research environment
Cross-functional and matrix-based teams
Combination of remote collaboration and site-focused activities
Fast-paced, compliance-driven clinical operations setting
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak | Shivalik |Punjab :
amritsar | Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Punjab | Rajpura |Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Kakinada | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Tamil Nadu :
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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Madhya Pradesh :
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Bhubaneswar | Rourkela |Chhattisgarh :
Bilaspur | Eot Municipality | Raipur |Uttarakhand :
Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
Digha | Kolkata | Mukundapur |Goa :
Goa | Panaji | Verna |Bihar :
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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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 :
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Boise |Colorado :
Boulder | Denver | Westminster |Connecticut :
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Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |South Carolina :
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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 :
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 :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |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 :
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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Ciudad de México | New Mexico |Dubai :
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King Abdullah Economic City | Najran | Khulais | Rabigh | 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 :
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