Job Title
Clinical Study Support Associate (Clinical Systems & Study Operations)
Experience: 2–3 Years
Education: Life Sciences / Allied Health / Nursing / Medical Lab Technology
Work Area: Clinical Research Operations
Compliance: ICH-GCP and applicable regulatory guidelines
Job Overview
This role supports clinical study execution through clinical systems management, study operations support, data review, investigator payments, and documentation handling.
You will ensure smooth study conduct by managing systems, supporting study teams, maintaining compliance, and assisting in financial and regulatory processes.
Key Responsibilities
1. Clinical Systems & Access Management
Manage clinical systems and user access (e.g., CTMS, IWRS, EDC)
Perform system setup for newly awarded studies
Support system compliance management (CTMS compliance)
Manage study-related communications across platforms
2. Study Database & eTMF Support
Maintain study databases (CTMS, IWRS, EDC, etc.)
Support eTMF (electronic Trial Master File) activities
Assist in document management including:
Collection
Review
Processing
Tracking
eTMF filing
3. Data Review & Issue Management
Support study data review activities
Follow up with CRAs for resolution of:
Open issues
Action items
Assist leads with study-specific data review tasks
Ensure timely escalation and issue resolution
4. Study Reporting & Metrics
Generate study-specific reports
Track and report study metrics as per management timelines
Support study performance monitoring activities
5. Investigator Payments Management
Review EDC, contracts, and mark payment statuses in CTMS:
Ready to Pay
Screen Failure
Coordinate with project teams for:
Invoice generation
Payment batch creation
Payment approvals
Perform:
Invoice Quality Checks (QC)
Payment reconciliation during study close-out or ad hoc requests
Out-of-pocket and pass-through expense processing
6. Study Start-Up & Regulatory Support
Assist in investigator submission package preparation
Support site/regulatory submissions
Assist study start-up teams with site activation activities
Support contract review and management within timelines
7. Administrative & Operational Support
Provide administrative and technical support to internal teams
Assist in implementation of updated processes and procedures
Ensure proper management of project documentation
Perform quality checks on completed work
8. Training, Compliance & Documentation
Follow all departmental SOPs and work instructions
Complete mandatory training within timelines
Maintain compliance with ICH-GCP guidelines
Ensure proper documentation and quality standards
Qualifications
Education
University/College degree in Life Sciences preferred
OR
Allied health certification (e.g., Nursing, Medical Lab Technology)
Experience
2–3 years in clinical research or related discipline
0–3 years in other professional roles
Strong understanding of:
Clinical trial processes
ICH-GCP guidelines
Regulatory requirements
Key Skills Required
Strong organizational and communication skills
High attention to detail
Ability to work in teams effectively
Ability to deliver consistent high-quality output
Strong computer and system handling skills
Ability to multitask and manage priorities
Strong documentation and tracking ability
Work Expectations
Follow SOPs and defined processes strictly
Handle multiple tasks and priorities
Ensure timely escalation of issues
Maintain high productivity and quality standards
Support global clinical trial operations
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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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
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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 :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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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 :
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Batavia | Blue Ash | Cincinnati | Cleveland | Columbus, | Dayton | Erie | Evendale | Franklin | Hamilton | Huber Heights | Kings Mills | Macedonia | Mason | Milford | Montgomery | Norwood | Oregoina | oxford | Waynesville |LA :
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Big Piney | Cokeville |Alabama :
Birmingham |Virginia :
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Boise |Colorado :
Boulder | Denver | Westminster |Connecticut :
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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 :
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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 :
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 :
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Lake Charles | Shreveport |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
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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 :
Richmond Hill | Uxbridge | Australia | North York | Mississauga | Renfrew |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |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 :
Estonia | Tartu |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 :
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 :
Yavne | Kfar Saba | Netanya | Tel Aviv | Be'Er Sheva |Remote :
Remote - Europe | Remote | Regulatory Labeling Manager (NA and LATAM Only) | Belgium | Slovakia | Zaragoza | Blue Bell | Thailand | Lousiana | Remote - Middle East | Remote, USA | Ireland | McFarland | Hungary | Remote - South America (Latin Americal) | Lenexa | Springville | Bishop | Green Way | Tulsa | Riga | Castlebar | Medan | Leinster | Bountiful | Xzagreb | Hammond | Texas | French | Manipal | Melbourne | Remote - Africa | Minnesota | Faridabad | Switzerland | Nairobi | Victoria |Republic of Colombia :
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New Mexico | Ciudad de México |Dubai :
Dubai |Makkah :
Rabigh | Jeddah | Najran | Riyadh | Khulais | King Abdullah Economic City |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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