Senior Clinical Research Associate (Senior CRA)
Location: Mumbai, Maharashtra, India
Company: Bristol Myers Squibb (BMS)
Employment Type: Full-Time
Role Summary
The Senior Clinical Research Associate (Senior CRA) serves as the primary site-facing representative responsible for ensuring the quality, integrity, compliance, and successful execution of clinical trials across all study phases. The role involves site qualification, initiation, monitoring, close-out activities, risk-based monitoring, regulatory compliance, investigator management, and patient safety oversight.
As a senior member of the Clinical Operations team, the Senior CRA acts as a subject matter expert in clinical trial conduct, ICH-GCP compliance, risk-based quality management (RBQM), root cause analysis, and CAPA management while supporting cross-functional collaboration and mentoring junior team members.
Key Responsibilities
Clinical Trial Monitoring & Site Management
Conduct:
Site Qualification Visits (SQV)
Site Initiation Visits (SIV)
Routine Monitoring Visits
Close-Out Visits (COV)
Ensure study execution aligns with:
Protocol Requirements
Site Monitoring Plans
BMS SOPs
ICH-GCP Guidelines
Local Regulatory Requirements
Monitor study progress and site performance throughout the clinical trial lifecycle.
Data Quality & Source Data Verification
Verify clinical trial data within:
Electronic Data Capture (EDC) Systems
Source Documents
Paper Records (where applicable)
Ensure:
Data Accuracy
Completeness
Consistency
Traceability
Support maintenance of ALCOA principles:
Attributable
Legible
Contemporaneous
Original
Accurate
Regulatory Compliance & GCP Oversight
Monitor site compliance with:
ICH-GCP
Local Regulatory Requirements
Sponsor Procedures
Ethical Standards
Support:
Sponsor Audits
Regulatory Inspections
Health Authority Inspections
Participate in development and implementation of CAPAs.
Ensure ongoing inspection readiness across assigned sites.
Investigator & Site Relationship Management
Develop and maintain strong relationships with:
Principal Investigators
Site Staff
Study Coordinators
Vendors
Internal Stakeholders
Serve as the primary sponsor representative at the site level.
Support investigator engagement and site performance improvement initiatives.
Motivate sites to achieve:
Enrollment Targets
Retention Goals
Study Milestones
Risk-Based Monitoring & Quality Management
Apply:
Risk-Based Monitoring (RBM)
Centralized Monitoring Principles
Targeted Monitoring Strategies
Remote Monitoring Techniques
Identify, assess, prioritize, and mitigate study risks.
Utilize risk indicators and operational metrics to adjust monitoring strategies.
Support proactive issue identification and resolution.
Site Feasibility & Study Start-Up Support
Assess investigator and site suitability for clinical trials.
Participate in:
Site Selection
Feasibility Assessments
Investigator Identification
Evaluate site resources, infrastructure, and study capabilities.
Support study start-up and activation activities.
Study Drug & Investigational Product (IMP) Oversight
Review and reconcile:
Investigational Product (IP)
Study Drug Accountability Records
Inventory Documentation
Ensure proper storage, dispensing, return, and destruction procedures.
Support label translation activities where required.
Verify compliance with protocol and regulatory requirements.
Ethics Committee & Regulatory Support
Assist with:
Ethics Committee (EC) Submissions
Institutional Review Board (IRB) Documentation
Informed Consent Form (ICF) Reviews
Collect and maintain regulatory documentation.
Ensure essential documents remain current and compliant.
Database Lock & Study Closeout Activities
Support site readiness for:
Database Lock
Query Resolution
Study Closure
Coordinate final data review and site documentation activities.
Ensure timely completion of closeout procedures and deliverables.
Audit, Inspection & CAPA Management
Participate in:
Internal Audits
Sponsor Audits
Regulatory Inspections
Lead site-level CAPA development and implementation.
Conduct root cause investigations for compliance and quality issues.
Ensure timely resolution of audit findings.
Leadership, Training & Mentorship
Serve as a mentor and subject matter expert for junior CRAs.
Deliver:
Monitoring Training
GCP Training
RBQM Training
Process Improvement Sessions
Support onboarding and competency assessments.
Share best practices and lessons learned across teams.
Cross-Functional Collaboration
Collaborate with:
Clinical Trial Managers (CTMs)
Medical Monitors
Data Management Teams
Regulatory Affairs
Pharmacovigilance
Vendors
Support effective study execution and issue resolution.
Escalate complex study issues to leadership as appropriate.
Required Qualifications
Education
Bachelor’s Degree in:
Life Sciences
Pharmacy
Biotechnology
Nursing
Medicine
Related Healthcare or Scientific Discipline
Experience
5–8+ years of experience in:
Clinical Research
Clinical Trial Monitoring
Site Management
CRO or Pharmaceutical Industry
Experience monitoring Phase I–IV clinical trials.
Experience in oncology trials is highly desirable.
Prior experience as an independent Clinical Research Associate required
Uttar Pradesh :
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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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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
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Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Geelong Vic | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | Whitesboro | Winston-Salem |Georgia :
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Bangor | Brewer |New Jersey :
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Birmingham |Virginia :
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Bloomington | West Lafayette |Florida :
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Boise |Colorado :
Boulder | Denver | Westminster |Connecticut :
Bridgeport | Bristol | Enfield | Groton | Hartford | New Haven | Newtown | South Windsor | Stamford | Storrs | West Hartford |North Caroline :
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 :
Charleston |Kansas :
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 :
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China | Quarry Bay |Liaoning :
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Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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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 :
Uxbridge | Richmond Hill | Australia | Renfrew | North York | Mississauga |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
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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 :
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Jakarta |East Java :
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Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
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Ciudad de México | New Mexico |Dubai :
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Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
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Sweden |Taipei :
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