Job Title: Sr CRA I / CRA 2 – Oncology – FSP West Region
Locations: 9 Locations (Northern CA, NV, AZ, ID, NM, OR, WA, CO)
Category: Clinical
Job ID: 254563
Job Summary:
The Senior CRA I is responsible for site monitoring and management for oncology clinical studies in the West Region. This includes ensuring protocol compliance, patient safety, data integrity, and efficient use of study resources. The role may involve acting as Local Project Coordinator or Lead CRA and participating in study planning, monitoring, and reporting.
Key Responsibilities:
1. Site Monitoring & Management:
Perform all aspects of study site monitoring, including routine monitoring, closeout visits, and maintenance of study files.
Conduct pre-study and initiation visits; liaise with vendors as needed.
Ensure study staff are properly trained and equipped to conduct the protocol.
Verify patient protection through adherence to informed consent procedures and protocol requirements.
Review source documents to ensure CRF and data collection integrity.
Monitor for missing or implausible data.
Ensure audit readiness at the site level.
Prepare accurate and timely trip reports.
Manage small projects under direction of Project Manager/Director.
2. Study Oversight & Leadership:
Serve as lead monitor for assigned protocol/project; assist in developing monitoring plans and reviewing trip reports.
Review project progress and initiate actions to achieve objectives.
Organize and present at Investigator Meetings.
Participate in protocol and CRF development.
Write clinical trial reports as assigned.
Act as contact for clinical trial supplies and vendors.
Undertake feasibility work and quality control visits when requested.
3. Regulatory & Administrative Responsibilities:
Recruit potential investigators, prepare EC submissions, notify regulatory authorities, translate study documentation, and organize study-related meetings.
Assist with study budget negotiation and legal agreements.
Track, report, and follow up on Serious Adverse Events (SAEs).
Independently perform CRF review, query generation, and resolution according to data review guidelines.
Coordinate designated clinical projects as Local Project Coordinator; may act as local client contact.
4. Mentoring & Team Support:
Assist with training, mentoring, and development of new employees through co-monitoring.
Resolve project-related problems and prioritize workload for self and team.
5. Additional Responsibilities:
Perform other duties as assigned.
Minimum Requirements:
Education:
University/college degree (Life Science preferred) or certification in allied health, nursing, medical, or laboratory technology.
Alternatively, 3+ years of relevant clinical research experience in pharmaceutical or CRO industries.
Experience:
Minimum 3 years of Clinical Monitoring experience.
Knowledge of SAE reporting, advanced site monitoring, study site management, and registry administration.
Skills:
Understanding of regulatory requirements and drug development process.
Fluent in English and local office language.
Ability to work with minimal supervision, plan and organize tasks, train and supervise junior staff.
Proficient computer skills.
Valid driver’s license.
Preferred Qualifications:
Additional 1+ year experience in related field (medical, clinical, pharmaceutical, laboratory, research, data analysis, data management, or technical writing).
Local project coordination and/or project management experience.
Physical Demands / Work Environment:
Travel: 60–80% overnight.
Target Pay Range:
$120,000 – $133,000
Additional Information:
Learn more about our EEO & Accommodations request.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tiruchirappalli | Trichy | Vellore | Yogyakarta |Himachal Pradesh :
Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Bhubaneswar | Rourkela |Chhattisgarh :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Abilene | Arlington | Austin | Boerne | Brenham | Bulverde | Carrollton | Cedar Hill | Corpus Christi | Corsicana | Dallas | Denton | El Paso | Fort Worth | Garland | Houston | Lakeway | Longview | Mcallen | North Richland Hills | Plano | Richardson | San Antonio | Seguin | Tyler | Waco |California :
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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 :
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Frank Scottile Blvd |Missouri :
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Berlin |Baden-Wurttemberg :
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Germany | GErmany |Lower Saxony :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Dún Laoghaire |Galway :
Galway |County Dublin :
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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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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 :
Uxbridge | North York | Richmond Hill | Renfrew | Mississauga | Australia |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |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 :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Japan | Saitama |Tokyo :
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New Mexico | Ciudad de México |Dubai :
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Rabigh | Jeddah | Najran | King Abdullah Economic City | Riyadh | Khulais |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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