Job Title: Clinical Research Associate II – Sponsor Dedicated
Location: Mexico (Client-Based; CDMX, Toluca, or Cuernavaca)
Job ID: 25003320
About Syneos Health:
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization that accelerates customer success by translating unique clinical, medical affairs, and commercial insights into actionable outcomes. With 29,000 employees across 110 countries, our mission is to enhance patient care and clinical trial quality through streamlined and innovative processes.
Why Syneos Health:
Career Development: Robust opportunities for career growth and progression.
Culture: Commitment to a Total Self culture where authenticity is valued.
Training: Access to technical and therapeutic training, plus continuous professional development.
Recognition: Peer recognition programs and a comprehensive total rewards package.
Key Responsibilities:
Site Management:
Perform site qualification, initiation, interim monitoring, management, and close-out visits (both on-site and remotely).
Evaluate site performance and provide actionable recommendations, escalating serious issues promptly.
Compliance and Data Integrity:
Ensure compliance with ICH-GCP, Good Pharmacoepidemiology Practice (GPP), applicable regulatory requirements, and protocol guidelines.
Verify that informed consent is properly performed and documented, maintaining patient confidentiality.
Data Verification and Query Resolution:
Conduct comprehensive source document reviews, ensuring that clinical data in case report forms (CRFs) is accurate and complete.
Apply query resolution techniques both remotely and on-site, working with site staff to drive resolution within agreed timelines.
Investigational Product (IP) Oversight:
Perform IP inventory, reconciliation, and review storage/security practices, ensuring IP management adheres to protocol requirements.
File Management:
Regularly review the Investigator Site File (ISF) for accuracy, timeliness, and completeness, and reconcile with the Trial Master File (TMF).
Ensure compliance with document archiving standards per local guidelines.
Documentation and Communication:
Document all activities via trip reports, confirmation letters, communication logs, and other required project documents according to SOPs and the Clinical Monitoring/Site Management Plan.
Support subject/patient recruitment, retention, and awareness initiatives.
Project Coordination:
Understand and manage site-level activities, budgets, and timelines to meet project deliverables.
May serve as the primary liaison with site personnel or collaborate with the Central Monitoring Associate.
Meetings and Training:
Prepare for and attend Investigator and sponsor meetings, as well as global project team meetings.
Provide guidance for audit readiness and assist in audit preparation and follow-up.
Real World Late Phase (RWLP) Specific Responsibilities:
Support the full study lifecycle from site identification to close-out.
Engage in chart abstraction, data collection, and collaboration with sponsor affiliates, medical science liaisons, and local country staff.
Proactively recommend potential sites based on local knowledge of treatment patterns and healthcare provider associations.
Assist in training junior staff when required.
Qualifications:
Education/Experience:
Bachelor’s degree in a related field or a Registered Nurse (RN) qualification, or an equivalent combination of education, training, and experience.
Regulatory Knowledge:
Solid understanding of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.
Technical Skills:
Proficient computer skills with an aptitude for embracing new technologies.
Communication Skills:
Excellent communication, presentation, and interpersonal skills.
Travel Requirements:
Ability to manage and sustain travel up to 75% on a regular basis.
Additional Information:
This job description is not exhaustive and may be modified at the Company’s discretion. Equivalent experience, skills, and/or education may be considered as substitutes for specific qualifications. Syneos Health adheres to all applicable local and international labor laws, including provisions under the Americans with Disabilities Act and the EU Equality Directive.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak | Shivalik |Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Tamil Nadu :
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 :
Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Rajpura |Madhya Pradesh :
Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Odisha :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
Digha | Kolkata | Mukundapur |Uttar Pradesh :
Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Goa :
Goa | Panaji | Verna |Bihar :
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 :
Aberdeen | Baltimore | Bel Air | Cheverly | Columbia | Elkridge | Gaithersburg | Largo | Linthicum | Rockville | Towson | Upper Marlboro | White Plains |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 |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 | Stanford | Stanton | St. Helena | Stockton | Sunnyvale | Temecula | Thousand Oaks | Valencia | Vallejo | West Sacramento | West Valley City | Whittier | Willits |New York :
Albany | Biddle | Brooklyn | Buffalo | Hauppauge | Hawthorne | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Pearl River | Poughkeepsie | Rensselaer | Rhinebeck | Syracuse | Utica | Watertown |New Mexico :
Albuquerque | Farmington | Santa Fe | Tucumcari |Pennsylvania :
Ambler | Bethlehem | Collegeville | Harrisburg | Lancaster | Marietta | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | Pottstown | Radnor | Sellersville | Southampton | Spring House | West Chester | Wyomissing |Alaska :
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 :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |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 | Newark | New Brunswick | 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 | Westfield | West Orange | Wharton | Whippany |Ohio :
Batavia | Blue Ash | Cincinnati | Cleveland | Columbus, | Dayton | Erie | Evendale | Franklin | Hamilton | Huber Heights | Kings Mills | Macedonia | Mason | Milford | Montgomery | Norwood | Oregoina | oxford | Waynesville |LA :
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Bellevue | Bothell | Friday Harbor | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Tacoma | Vancouver |Oregon :
Bend | Coquille | Corvallis | Eugene | Florence | Grants Pass | John Day | Lake Oswego | Lakeview | Portland | Reedsport | Roseburg | Salem | Springfield | Woodburn |Wyoming :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Arkansas | Remote Australia |New South Wales :
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Nedlands |Queensland :
Queensland |Melbourne :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Sheffield |Oxfordshire :
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Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
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Bangkok |Israel :
Be'Er Sheva | Yavne | Kfar Saba | Tel Aviv | Netanya |Remote :
Bountiful | Victoria | Remote - Middle East | Blue Bell | Ireland | Xzagreb | Remote - Europe | Thailand | Remote - Africa | Springville | Slovakia | Green Way | Belgium | Bishop | Lousiana | Zaragoza | Faridabad | Remote - South America (Latin Americal) | McFarland | Riga | Nairobi | Regulatory Labeling Manager (NA and LATAM Only) | Leinster | Tulsa | Minnesota | Texas | Hammond | Switzerland | Manipal | Melbourne | Remote | Remote, USA | Hungary | French | Castlebar | Medan | Lenexa |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 :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
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