Job Title: Regulatory Operations Assistant
Location: Foster City, CA
Employment Type: Contract
Company Overview:
Integrated Resources, Inc. (IRI) is a workforce solutions provider, delivering strategic services to efficiently manage talent and business operations. Established in 1996, IRI has built a strong team of experts, expanding into new sectors and achieving steady growth over the years.
Position Summary:
The Regulatory Operations Assistant will be involved in the clinical trial disclosure and transparency function. The role primarily supports the Disclosure & Transparency team in clinical trial registrations, results postings, and the extraction and redaction of clinical documents in line with EMA Policy 0070.
Key Responsibilities:
Clinical Trial Registration: Assist with the registration of new clinical trials on ClinicalTrials.gov and the EU Clinical Trial Register (EudraCT).
Results Posting: Support the posting of clinical trial results and relevant updates in EudraCT.
Policy 0070:
Collect and organize required documents.
Assist in the extraction and preparation of documents for Policy 0070.
Perform auto-redaction and manual redaction of clinical documents.
Facilitate the review process and publication of redacted documents.
Prepare other Policy 0070 materials, including Justification Tables, Anonymization Reports, and Document Inventories.
Document Management: Perform quality control and editing reviews of clinical and regulatory documents such as CSRs, IBs, CTDs.
Team Participation: Attend routine group meetings and, under guidance, participate in cross-functional meetings.
Qualifications and Skills:
Education: Bachelor’s degree in a relevant field.
Experience: At least 2 years of relevant experience in clinical research or regulatory operations, preferably in Clinical R&D (Clinical Operations).
Knowledge:
Basic understanding of Clinical Development and associated regulations (FDA, EMA).
Familiarity with industry best practices (ICH, GCP).
Skills:
Strong organizational skills with the ability to manage multiple projects.
High attention to detail and ability to work under tight deadlines.
Excellent verbal and written communication skills.
Ability to work well in team settings and communicate effectively with various stakeholders.
Andra Pradesh :
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Bilaspur | Eot Municipality | Raipur |Delhi :
Delhi | India | New Delhi | PAN-India |Goa :
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Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
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Baddi | Solan |India :
Siliguri |Jharkhand :
Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Mangaluru | Mysore | Udupi |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Madhya Pradesh :
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Pondicherry (Puducherry) :
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Digha | Kolkata | Mukundapur |Alabama :
Birmingham |Alaska :
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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 :
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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 :
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Garden city | Kansas City | Lawrence | McPherson |Kentucky :
Edgewood | Ft MItchell | Louisville | Shelbyville |Kington :
Frank Scottile Blvd |LA :
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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 :
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Dickinson |northeastern :
New Hampshire |Ohio :
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Mexico |South Carolina :
Charleston |Tennessee :
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Appleton | Pleasant Prairie | Portage | Waukesha |Wyoming :
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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 :
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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 :
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Vienna |Antwerp :
Heist op den Berg |Brussels :
Brussels |Flemish Brabant :
Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
Canada |Ontario :
Richmond Hill | Renfrew | Mississauga | North York | Uxbridge |Quebec :
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Croatia |Zagreb :
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Tallinn |Chuuk :
North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |France :
Lyon | Paris |Attica :
Koropi | Athens |Greece :
Greece |East Java :
Surabaya |Jakarta :
Jakarta |Israel :
Be'Er Sheva | Netanya | Tel Aviv | Yavne | Kfar Saba |Italy :
Italy |Lombardy :
Rho |Japan :
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Remote Korea |Republic of Korea :
Seoul |Kuala Lumpur :
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Ciudad de México |North Island :
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Lima |Cebu Province :
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Manila |Mazovia :
Warsaw |Remote :
Remote - Europe | McFarland | Remote - Middle East | Remote | Remote, USA | Victoria | Melbourne | Lenexa | Remote - South America (Latin Americal) | Switzerland | Remote - Africa |Bucharest :
Bucharest |Makkah :
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Niš |Singapore :
Singapore |South Africa :
South Africa | Midrand |Brazil :
Sao paulo | Brazil |South America :
Peru | Argentina |Catalonia :
Barcelona |Madrid :
Madrid |Sweden :
Sweden |Taipei :
Taipei |Williamson :
Brentwood |Republic of Thailand :
Bangkok |Kyiv Oblast :
Kyiv |Dubai :
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Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |