Sr. Clinical Research Associate
Company: iHealth Labs Inc
Location: Sunnyvale, CA, USA
Employment Type: Full-Time
Compensation: $60,000 to $100,000 per year
Benefits Offered: Dental, Life, Medical, Paid Time Off, Retirement, Vision
Work Location: Sunnyvale, California
PRIMARY DUTIES AND RESPONSIBILITIES:
As a Sr. Clinical Research Associate, you will be responsible for performing study site management activities. Key responsibilities include conducting on-site or remote monitoring activities.
Perform site qualification, Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), and study close-out visits. Prepare visit reports and other documents associated with these visits.
Evaluate site facilities and staff to ensure compliance with ICH-GCP guidelines. Assist in and provide feedback on site issues during contract development and negotiation.
Participate in investigator meetings and monitor workshops. Oversee and facilitate study start-up activities.
Evaluate the quality and integrity of study site practices, ensuring adherence to protocol and applicable regulations. Raise and close monitoring discrepancies.
Conduct IMVs to confirm that clinical sites comply with study protocols, Institutional Review Board (IRB) requirements, and other regulatory stipulations. Prepare IMV reports and other documentation associated with these visits.
Maintain and update the TMF with site information, study contacts, and regulatory documents.
Assist in the termination of clinical studies by identifying items and issues for review or follow-up. Assemble necessary documents, conduct site termination visits (which include test article reconciliation and file review), and retrieve relevant codes and documents. Prepare study termination reports.
Ensure appropriate transmission of clinical trial data to data management sites. Review case report queries and clarify or obtain changes to data as needed.
During the close-out visit, the CRA must ensure that the clinical trial site has complied with the study protocol, Good Clinical Practice (GCP), and regulatory requirements. The CRA is also responsible for collecting all trial-related documents and archiving them.
Travel is estimated to be required 25%-50% of the time.
QUALIFICATION AND SKILLS:
Bachelor's degree in a medical/life sciences-related field.
Minimum 2 years monitoring experience. Experience related to CGM is required.
Fluent in English with the ability to work independently with minimal supervision.
Excellent knowledge of GCP guidelines, FDA regulations, and other regulations applicable to investigational device studies.
Good written and verbal communication skills.
Ability to communicate and interact competently and professionally at all levels within a broad, complex clinical research environment.
Ability to provide technical advice, guidance, and support to professional staff in an area of specialty.
Bilingual in Chinese is required.
BENEFITS:
Medical, Dental, Vision, Life Insurance, and 401K
Paid Time Off, Federal Holidays, and Leaves
Annual Performance-Based Bonus
Sr. Clinical Research Associate - slug:
Sr. Clinical Research Associate
Company: iHealth Labs Inc
Location: Sunnyvale, CA, USA
Employment Type: Full-Time
Compensation: $60,000 to $100,000 per year
Benefits Offered: Dental, Life, Medical, Paid Time Off, Retirement, Vision
Work Location: Sunnyvale, California
PRIMARY DUTIES AND RESPONSIBILITIES:
As a Sr. Clinical Research Associate, you will be responsible for performing study site management activities. Key responsibilities include conducting on-site or remote monitoring activities.
Perform site qualification, Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), and study close-out visits. Prepare visit reports and other documents associated with these visits.
Evaluate site facilities and staff to ensure compliance with ICH-GCP guidelines. Assist in and provide feedback on site issues during contract development and negotiation.
Participate in investigator meetings and monitor workshops. Oversee and facilitate study start-up activities.
Evaluate the quality and integrity of study site practices, ensuring adherence to protocol and applicable regulations. Raise and close monitoring discrepancies.
Conduct IMVs to confirm that clinical sites comply with study protocols, Institutional Review Board (IRB) requirements, and other regulatory stipulations. Prepare IMV reports and other documentation associated with these visits.
Maintain and update the TMF with site information, study contacts, and regulatory documents.
Assist in the termination of clinical studies by identifying items and issues for review or follow-up. Assemble necessary documents, conduct site termination visits (which include test article reconciliation and file review), and retrieve relevant codes and documents. Prepare study termination reports.
Ensure appropriate transmission of clinical trial data to data management sites. Review case report queries and clarify or obtain changes to data as needed.
During the close-out visit, the CRA must ensure that the clinical trial site has complied with the study protocol, Good Clinical Practice (GCP), and regulatory requirements. The CRA is also responsible for collecting all trial-related documents and archiving them.
Travel is estimated to be required 25%-50% of the time.
QUALIFICATION AND SKILLS:
Bachelor's degree in a medical/life sciences-related field.
Minimum 2 years monitoring experience. Experience related to CGM is required.
Fluent in English with the ability to work independently with minimal supervision.
Excellent knowledge of GCP guidelines, FDA regulations, and other regulations applicable to investigational device studies.
Good written and verbal communication skills.
Ability to communicate and interact competently and professionally at all levels within a broad, complex clinical research environment.
Ability to provide technical advice, guidance, and support to professional staff in an area of specialty.
Bilingual in Chinese is required.
BENEFITS:
Medical, Dental, Vision, Life Insurance, and 401K
Paid Time Off, Federal Holidays, and Leaves
Annual Performance-Based Bonus
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Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Mangaluru | Mysore | Udupi |Kerala :
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Panjab :
Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Punjab :
Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Sikkim :
Rangpo |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tiruchirappalli | Trichy | Vellore |Uttar Pradesh :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |West Bengal :
Digha | Kolkata | Mukundapur |Alabama :
Birmingham |Alaska :
Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Albama :
Tuscaloosa |Arizona :
Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |Arkansas :
Fort Smith |California :
Adelanto | Alameda | Albion | Arcata | Atherton | Berkeley | Brisbane | Burlingame | Burney | California | Carlsbad | Crescent City | Davis | Downey | El Monte | El Segundo | Emeryville | Eureka | Fortuna | Foster City | Fremont | Glendale | Hayward | Hoopa | Irvine | La Jolla | Los Angeles | Martinez | McKinleyville | Menlo Park | Millbrae | Milpitas | Morgan Hill | Mountain View | Nevada | Novato | Oakland | Orange | Pacheco | Palo Alto | Pasadena | Pleasanton | Pomona | Redding | Redwood City | Riverside | Roseville | Sacramento | San Bernardino | San Carlos | San Diego | San Francisco | San Gabriel | San Jose | San Mateo | San Rafael | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | South San Francisco | St. Helena | Stanford | Stanton | Stockton | Sunnyvale | Temecula | Thousand Oaks | Valencia | Vallejo | West Sacramento | West Valley City | Whittier | Willits |Colorado :
Boulder | Denver | Westminster |Connecticut :
Bridgeport | Bristol | Enfield | Groton | Hartford | New Haven | Newtown | South Windsor | Stamford | Storrs | West Hartford |D.C :
Washington |Delaware :
Wilmington |Florida :
Boca Raton | Brooksville | Clearwater | Coral Gables | Coral Springs | Daytona Beach | Gainesville | Hollywood | Jacksonville | Maitland | Miami | Naples | North Miami Beach | Orlando | Pembroke Pines | Plantation | Port St. Lucie | Rueil-Malmaison | Saint Petersburg | Stuart | Tallahassee | Tampa | West Palm Beach | Winter Haven |Georgia :
Atlanta | Augusta | Rome |Hawaii :
Hilo | Honolulu |Idaho :
Boise |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Indiana :
Bloomington | West Lafayette |Kansas :
Garden city | Kansas City | Lawrence | McPherson |Kentucky :
Edgewood | Ft MItchell | Louisville | Shelbyville |Kington :
Frank Scottile Blvd |LA :
Baton Rouge | Monroe | New Orleans |Louisiana :
Lake Charles | Shreveport |Maine :
Bangor | Brewer |Maryland :
Aberdeen | Baltimore | Bel Air | Cheverly | Columbia | Elkridge | Gaithersburg | Largo | Linthicum | Rockville | Towson | Upper Marlboro | White Plains |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
Fulton | Milan | St. Louis |Nebraska :
Hebron | Nebraska City |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
Lebanon | Macon | Manchester |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | Mount Arlington | New Brunswick | Newark | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | West Orange | Westfield | Wharton | Whippany |New Mexico :
Albuquerque | Farmington | Santa Fe | Tucumcari |New York :
Albany | Biddle | Brooklyn | Buffalo | Hauppauge | Hawthorne | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Pearl River | Poughkeepsie | Rensselaer | Rhinebeck | Syracuse | Utica | Watertown |North Carolina :
Concord | Lumberton | North Carolina |North Caroline :
Carolina Beach | Chapel Hills | Durham | Holly Springs | Morrisville | Philippines | Raleigh | Rocky Mount | Sanford | Scottsdale |North Dakota :
Dickinson |northeastern :
New Hampshire |Ohio :
Batavia | Blue Ash | Cincinnati | Cleveland | Columbus, | Dayton | Erie | Evendale | Franklin | Hamilton | Huber Heights | Kings Mills | Macedonia | Mason | Milford | Montgomery | Norwood | Oregoina | oxford | Waynesville |Oklahoma :
Oklahoma City |Oregon :
Bend | Coquille | Corvallis | Eugene | Florence | Grants Pass | John Day | Lake Oswego | Lakeview | Portland | Reedsport | Roseburg | Salem | Springfield | Woodburn |Pennsylvania :
Ambler | Bethlehem | Collegeville | Harrisburg | Lancaster | Marietta | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | Radnor | Sellersville | Southampton | Spring House | West Chester | Wyomissing |Portugal :
Lisbon | Oeiras | Portugal |Puerto Rico :
San Juan |Republic of Mexico :
Mexico |South Carolina :
Charleston |Tennessee :
Knoxville | Memphis | Nashville |Texas :
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 |United states :
fairmont | Georgia | Keene | OH | United States |United States :
Hawai | kentucky | Sylmar | Woonsocket |Virginia :
Blacksburg | Charlottesville | Falls Church | Mechanicsville |Washington :
Bellevue | Bothell | Friday Harbor | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Tacoma | Vancouver |WI :
Madison | Wausau |Wisconsin :
Appleton | Pleasant Prairie | Portage | Waukesha |Wyoming :
Big Piney | Cokeville |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Berlin :
Mitte |Brandenburg :
Berlin |Germany :
Germany | GErmany |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Lower Saxony :
Gottingen | Hannover | Leipzig |Mecklenburg Vorpommern :
Rostock |Munich :
Bavaria |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Rotherbaum :
Hamburg |Saarland :
Saarbrucken |Saxony Anhalt :
Halle |Schleswig Holstein :
Kiel |Belgium :
Wavre |BULGARIA :
Bulgaria |Denmark :
Copenhagen | Denmark |Europe :
France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Hungary :
Budapest |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Serbia :
Belgrade | Serbia |Switzerland :
Basel | Zurich |Carlow :
Carlow |Cork :
Brinny | Ringaskiddy |County Dublin :
Swords |Dún Laoghaire :
Dún Laoghaire |Meath :
Dunboyne |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Tipperary :
Ballydine |Ulster :
Donegal |China :
China | Quarry Bay |Hubei :
Wuhan |Liaoning :
Dalian |Republic of China :
Beijing |Shanghai Sai :
Shanghai Shi |Tokiyo :
Osaka | Tokyo |Zhejiang :
Hangzhou |Melbourne :
South Yarra |New South Wales :
Ballina | Sydney |Queensland :
Queensland |Remote Australia :
Remote Australia |Republic of Western Australia :
Nedlands |Capital of Netherland :
Amsterdam |Netherlands :
Netherlands |Noord Holland :
Haarlem |North Brabant :
Breda |South Holland :
Leiden |North Yorkshire :
Harrogate |Oxfordshire :
Witney |South Yorkshire :
Sheffield |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
Buenos Aires |Austria :
Austria |Vienna :
Vienna |Antwerp :
Heist op den Berg |Brussels :
Brussels |Flemish Brabant :
Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
Canada |Ontario :
North York | Uxbridge | Richmond Hill | Renfrew | Mississauga |Quebec :
Montreal |Chile :
Santiago |Republic of Colombia :
Bogota |Croatia :
Croatia |Zagreb :
Zagreb |Bohemia :
Prague |Republic of Egypt :
Cairo |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Chuuk :
North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |France :
Lyon | Paris |Attica :
Athens | Koropi |Greece :
Greece |East Java :
Surabaya |Jakarta :
Jakarta |Israel :
Tel Aviv | Netanya | Kfar Saba | Be'Er Sheva | Yavne |Italy :
Italy |Lombardy :
Rho |Japan :
Japan | Saitama |Tokyo :
Otemachi |Kazakhstan :
Almaty |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kuala Lumpur :
Kuala Lumpur |Mexico :
Ciudad de México |North Island :
Auckland |Lima Region :
Lima |Cebu Province :
Cebu City |Philippines :
Manila |Mazovia :
Warsaw |Remote :
Lenexa | Remote | McFarland | Switzerland | Remote - Europe | Remote - Africa | Remote - South America (Latin Americal) | Remote, USA | Remote - Middle East | Melbourne |Bucharest :
Bucharest |Makkah :
Riyadh | King Abdullah Economic City | Najran | Jeddah | Rabigh | Khulais |Nišava District :
Niš |Singapore :
Singapore |South Africa :
Midrand | South Africa |Brazil :
Brazil | Sao paulo |South America :
Argentina | Peru |Catalonia :
Barcelona |Madrid :
Madrid |Sweden :
Sweden |Taipei :
Taipei |Williamson :
Brentwood |Republic of Thailand :
Bangkok |Kyiv Oblast :
Kyiv |Dubai :
Dubai |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |