Job Title: (Sr.) Clinical Research Associate
Company: iHealth Labs Inc
Location: Sunnyvale, CA, USA
Employment Type: Full-Time
Salary Range: $60,000 to $100,000 per year
Benefits Offered: Dental, Life, Medical, Paid Time Off, Retirement, Vision
Position Summary:
iHealth Labs Inc is seeking a highly motivated and experienced Senior Clinical Research Associate (CRA) to join their team. The (Sr.) Clinical Research Associate will play a critical role in performing site management activities for clinical studies, ensuring adherence to protocols and regulations. The role requires experience in clinical trial management, site monitoring, and a strong knowledge of regulatory guidelines, with a focus on Continuous Glucose Monitoring (CGM). Travel is required approximately 25%-50% of the time.
Key Responsibilities:
Conduct on-site and remote monitoring activities, including site qualification, Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), and study close-out visits.
Evaluate site facilities and staff for compliance with ICH-GCP guidelines.
Assist in site contract development and negotiation and participate in investigator meetings and workshops.
Oversee study start-up activities and ensure that study sites are in compliance with study protocols, IRB requirements, and regulatory stipulations.
Raise and close monitoring discrepancies and assist with the termination of clinical studies.
Ensure appropriate transmission of clinical trial data and manage data discrepancies.
Ensure clinical trial sites comply with GCP, protocol, and regulatory requirements during close-out visits.
Maintain and update the Trial Master File (TMF) with site information and regulatory documents.
Qualifications and Skills:
Education: Bachelor's degree in a medical or life sciences-related field.
Experience: Minimum of 2 years of clinical monitoring experience, with prior experience in Continuous Glucose Monitoring (CGM).
Skills:
Excellent knowledge of GCP guidelines, FDA regulations, and other relevant clinical research regulations.
Strong written and verbal communication skills.
Ability to work independently with minimal supervision.
Bilingual in Chinese required.
Ability to interact competently and professionally with clinical research teams.
Benefits:
Medical, Dental, Vision, Life Insurance, and 401K
Paid Time Off, Federal Holidays, and Leaves
Annual Performance-Based Bonus
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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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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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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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
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Swords |Republic of China :
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China | Quarry Bay |Liaoning :
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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 :
Uxbridge | North York | Mississauga | Renfrew | Richmond Hill | Australia |Canada :
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Zaventem |South America :
Peru | Argentina |Brazil :
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Greece |North Island :
Auckland |New Zealand :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
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Japan | Saitama |Tokyo :
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Kfar Saba | Yavne | Be'Er Sheva | Tel Aviv | Netanya |Remote :
Ireland | McFarland | Faridabad | Remote, USA | Minnesota | Remote | Thailand | Zaragoza | Remote - Middle East | Texas | Victoria | Belgium | Xzagreb | Medan | Melbourne | Nairobi | Hammond | Lenexa | Remote - Africa | Remote - South America (Latin Americal) | Green Way | Bountiful | Bishop | Blue Bell | Regulatory Labeling Manager (NA and LATAM Only) | Remote - Europe | Hungary | Springville | Manipal | French | Switzerland | Tulsa | Lousiana | Riga | Slovakia | Leinster | Castlebar |Republic of Colombia :
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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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