• Login / Signup
    • Instagram
    youtube
    Facebook

    Cra Ii/Sr Cra (Poland) - Sponsor-Dedicated

    Syneos Health
    2+ years
    Not Disclosed
    Remote, USA
    10 Nov. 6, 2024
    Job Description
    Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Clinical Research Associate II/Sr CRA – Sponsor-dedicated
    Company: Syneos Health®
    Location: [Insert Location or specify remote work]

    About Syneos Health:

    Syneos Health® is a leading fully integrated biopharmaceutical solutions organization designed to accelerate customer success. By translating unique clinical, medical affairs, and commercial insights into outcomes, we address modern market challenges. With a focus on simplifying and streamlining our work, Syneos Health strives to be the easiest organization to collaborate with and the best place to work.

    As a global team of problem solvers, we’re dedicated to driving innovation and helping our customers achieve their goals faster. Join us as we deliver life-changing therapies to patients across the world.

    Why Syneos Health?

    At Syneos Health, we are deeply committed to career development, employee engagement, and a Total Self culture, where you can be your authentic self. Our diverse and inclusive environment encourages collaboration, growth, and recognition. We focus on building a company we all want to work for—one that values different perspectives and experiences, making us stronger and more innovative.

    Job Responsibilities:

    Regulatory Compliance & Site Management:

    • Ensure compliance with regulatory, ICH-GCP, and protocol standards at study sites.
    • Evaluate site performance, assess risks, and provide actionable recommendations.
    • Immediately communicate and escalate critical issues to the project team, creating action plans for resolution.
    • Oversee the informed consent process and ensure patient confidentiality at all times.

    Monitoring & Data Management:

    • Conduct on-site and remote monitoring activities as per Clinical Monitoring/Study Monitoring Plan (CMP/SMP).
    • Perform Source Document Review and Source Data Verification (SDV), ensuring data integrity and accuracy in case report forms (CRFs).
    • Resolve data queries, verify data completeness, and follow up on protocol deviations.
    • Ensure proper documentation of site activities, including monitoring reports, communication logs, and follow-up letters.

    Investigational Product (IP) Management:

    • Manage IP inventory and ensure proper dispensing, administration, and security per the protocol.
    • Ensure compliance with local regulations regarding blinded or randomized information related to IP.

    Team & Site Collaboration:

    • Act as a liaison between study site personnel and internal project teams.
    • Assist with training site staff to ensure compliance with study protocols and regulatory requirements.
    • Collaborate with the Site Manager to manage site operations and maintain training and delegation logs.

    Audit & Compliance Preparation:

    • Assist with site audit preparation and audit readiness at both the site and project levels.
    • Provide guidance on audit standards and facilitate corrective actions following audits.

    Travel & Site Visits:

    • Ability to travel up to 75% regularly to monitor sites and perform study-related activities.

    Qualifications:

    • Bachelor’s degree or RN in a related field, or an equivalent combination of education, training, and experience.
    • Strong understanding of Good Clinical Practice (GCP), ICH guidelines, and other regulatory requirements.
    • Proficient with computer systems and a willingness to embrace new technologies.
    • Excellent communication, presentation, and interpersonal skills.
    • Ability to manage up to 75% travel on a regular basis.

    Why Work at Syneos Health?

    • Syneos Health has partnered with 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products.
    • With over 200 studies across 73,000 sites and 675,000 trial patients, we are proud of our global reach and impact.
    • We offer a competitive benefits package, including health insurance, retirement planning, wellness programs, and more.

    Join us at Syneos Health, where work matters everywhere. Learn more about us and apply today at our Careers Page.

    Latest Jobs

    Associate Director - Medical Science Liaison- Neuroscience- Virginia / Washington / Maryland Region

    Lilly
    Richmond Hill

    Pharmacovigilance Manager

    Atvigilx
    Pune

    Research Associate/ Senior Research Associate

    Enveda Biosciences
    Hyderabad

    Assoc Medical Data Review Mgr

    Iqvia
    Bangalore

    Pharmacovigilance Services Associate

    Accenture
    Chennai

    Senior Manager - Medical Affairs Professional - Obesity

    Lilly
    Gurgaon

    Medical Affairs Professional - Oncology (Medical Advisor)

    Lilly
    Gurgaon

    Medical Science Liaison - Biomedicines

    Lilly
    Gurgaon

    Alliance Diabetes & Obesity Crp

    Lilly
    Bangkok Gurgaon Singapore

    Sr. Manager/Manager Medical Scientific Liaison - Oncology

    Lilly
    Mumbai

    Pharma Jobs in India

    Andra Pradesh :

    Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Visakhapatnam |

    Assam :

    Dibrugarh | Diburghar | Guwahati |

    Bihar :

    Hajipur | Patna |

    Chhattisgarh :

    Bilaspur | Eot Municipality | Raipur |

    Delhi :

    Delhi | India | New Delhi | PAN-India |

    Goa :

    Goa | Panaji | Verna |

    Gujarat :

    Ahmedabad | Baroda | Gandhinagar | Halol | Mehsana | Tarasadi | Vadodara | Vapi |

    Haryana :

    Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak |

    Himachal Pradesh :

    Baddi | Solan |

    India :

    Siliguri |

    Jharkhand :

    Ranchi |

    Karnataka :

    B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Mangaluru | Mysore | Udupi |

    Kerala :

    Kannur | Kochi | Malappuram | Thiruvananthapuram |

    Madhya Pradesh :

    Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |

    Maharashtra :

    Ambernath | Amravati | Aurangabad | Dhule | Jalgaon | Kolhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tarapur | Thane | Vikhroli |

    Odisha :

    Bhubaneswar | Rourkela |

    PAN-India :

    Panjab :

    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 |

    Uttar Pradesh :

    Gajraula | Gautam buddha Nagar | Ghaziabad | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Varanasi |

    Uttarakhand :

    Dehradun | Nainital | Rishikesh |

    West Bengal :

    Digha | Kolkata | Mukundapur |

    Pharma Jobs in United States

    Alabama :

    Birmingham |

    Alaska :

    Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |

    Albama :

    Tuscaloosa |

    Arizona :

    Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Tempe | Tucson | Yuma |

    Arkansas :

    Fort Smith |

    California :

    Alameda | Albion | Arcata | Berkeley | Brisbane | Burney | California | Carlsbad | Crescent City | Davis | Downey | El Monte | El Segundo | Emeryville | Eureka | Fortuna | Foster City | Fremont | Glendale | Hoopa | Irvine | La Jolla | Los Angeles | Martinez | McKinleyville | Menlo Park | Morgan Hill | Mountain View | Nevada | Oakland | Pacheco | Palo Alto | Pasadena | Pleasanton | Redding | Redwood City | Riverside | Sacramento | San Bernardino | San Diego | San Francisco | San Gabriel | San Jose | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | South San Francisco | Stanford | Stanton | Stockton | Temecula | Thousand Oaks | Valencia | Vallejo | West Valley City | Whittier | Willits |

    Colorado :

    Denver |

    Connecticut :

    Bridgeport | Bristol | Enfield | Groton | Newtown | South Windsor | Stamford | Storrs | West Hartford |

    D.C :

    Washington |

    Delaware :

    Wilmington |

    Florida :

    Boca Raton | Clearwater | Coral Gables | Coral Springs | Daytona Beach | Gainesville | Jacksonville | Maitland | Miami | Naples | Orlando | Pembroke Pines | Port St. Lucie | Rueil-Malmaison | Stuart | Tallahassee | Tampa | West Palm Beach |

    Georgia :

    Atlanta | Rome |

    Hawaii :

    Hilo | Honolulu |

    Idaho :

    Boise |

    Illinois :

    Abbott Park | 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 | 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 |

    Massachusetts :

    Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |

    Michigan :

    Detroit | Houghton Lake |

    Minnesota :

    Duluth | Eden Prairie | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | St.Paul |

    Missouri :

    Fulton | Milan | St. Louis |

    Nebraska :

    Hebron | Nebraska City |

    Nevada :

    Las Vegas | Tonopah | Tonopsh |

    New Hampshire :

    Lebanon | Manchester |

    New Jersey :

    Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | 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 :

    Farmington | Santa Fe | Tucumcari |

    New York :

    Albany | Biddle | Buffalo | Hawthorne | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Pearl River | Rensselaer | Syracuse | Utica |

    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 :

    Cincinnati | Cleveland | Columbus, | Dayton | Erie | Macedonia | Oregoina | oxford | Waynesville |

    Oklahoma :

    Oklahoma City |

    Oregon :

    Bend | Coquille | Corvallis | Eugene | Grants Pass | John Day | Lake Oswego | Lakeview | Portland | Reedsport | Roseburg | Salem | Springfield | Woodburn |

    Pennsylvania :

    Ambler | Collegeville | Harrisburg | Lancaster | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | Radnor | Spring House | West Chester | Wyomissing |

    Portugal :

    Lisbon | Portugal |

    Puerto Rico :

    San Juan |

    Republic of Mexico :

    Mexico |

    South Carolina :

    Charleston |

    Tennessee :

    Memphis | Nashville |

    Texas :

    Abilene | Arlington | Austin | Brenham | Bulverde | Corpus Christi | Corsicana | Dallas | Fort Worth | Houston | Lakeway | Longview | Plano | Richardson | San Antonio | Tyler | Waco |

    United states :

    fairmont | Georgia | United States |

    United States :

    Hawai | Sylmar |

    Virginia :

    Blacksburg | Charlottesville | Falls Church |

    Washington :

    Bellevue | Bothell | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Vancouver |

    WI :

    Madison | Wausau |

    Wisconsin :

    Portage |

    Wyoming :

    Big Piney | Cokeville |

    Pharma Jobs in Germany

    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 |

    Pharma Jobs in Europe

    BULGARIA :

    Bulgaria |

    Denmark :

    Copenhagen | Denmark |

    Europe :

    Latvia | Leuven | Poland | Spain |

    Finland :

    Finland |

    Hungary :

    Budapest |

    Istanbul :

    Istanbul | Turkey |

    Norway :

    Norway | NOrway |

    Romania :

    Romania |

    Serbia :

    Belgrade | Serbia |

    Switzerland :

    Basel | Zurich |

    Pharma Jobs in China

    China :

    China |

    Hubei :

    Wuhan |

    Liaoning :

    Dalian |

    Republic of China :

    Beijing |

    Shanghai Sai :

    Shanghai Shi |

    Tokiyo :

    Osaka | Tokyo |

    Zhejiang :

    Hangzhou |

    Pharma Jobs in Ireland

    Cork :

    Ringaskiddy |

    County Dublin :

    Swords |

    Dún Laoghaire :

    Dún Laoghaire |

    Republic of Ireland :

    Dublin | Limerick | Waterford |

    Ulster :

    Donegal |

    Pharma Jobs in Australia

    New South Wales :

    Ballina | Sydney |

    Queensland :

    Queensland |

    Remote Australia :

    Remote Australia |

    Republic of Western Australia :

    Nedlands |

    Pharma Jobs in Netherland

    Capital of Netherland :

    Amsterdam |

    Netherlands :

    Netherlands |

    Noord Holland :

    Haarlem |

    South Holland :

    Leiden |

    Pharma Jobs in United Kingdom

    Antrim :

    Larne |

    Cheshire :

    Runcorn |

    Hertfordshire :

    Welwyn |

    Surrey :

    Pirbright |

    Pharma Jobs in Argentina & Austria & Belgium & Bosnia and Herzegovina & Bulgaria & Canada & Chile & Colombia & Croatia & Czechia & Egypt & England & Estonia & Federated States of Micronesia & Finland & France & Greece & Indonesia & Israel & Italy & Japan & Kazakhstan & Korea & malaysia & Mexico & Philippines & Poland & Portugal & Remote & Romania & Saudi Arabia & Serbia & Singapore & South Afrcia & South America & Spain & Sweden & Taiwan & Tennessee & Thailand & Turkey & Ukraine & United Arab Emirates & Vietnam

    Buenos Aires :

    Buenos Aires |

    Austria :

    Austria |

    Vienna :

    Vienna |

    Antwerp :

    Heist op den Berg |

    Brussels :

    Brussels |

    Bosnia and Herzegovina :

    Sarajevo |

    Sofia City :

    Sofia |

    Canada :

    Canada |

    Ontario :

    Uxbridge | North York | Richmond Hill | Mississauga |

    Quebec :

    Montreal |

    Chile :

    Santiago |

    Republic of Colombia :

    Bogota |

    Croatia :

    Croatia |

    Zagreb :

    Zagreb |

    Bohemia :

    Prague |

    Republic of Egypt :

    Cairo |

    South Yorkshire :

    Sheffield |

    United Kingdom :

    Harlow | Salt Lake City | United Kingdom | Maidenhead | Stirling | Leeds | London |

    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 | Be'Er Sheva | Netanya | Kfar Saba |

    Italy :

    Italy |

    Lombardy :

    Rho |

    Japan :

    Japan |

    Tokyo :

    Otemachi |

    Kazakhstan :

    Almaty |

    Remote Korea :

    Remote Korea |

    Republic of Korea :

    Seoul |

    Kuala Lumpur :

    Kuala Lumpur |

    Mexico :

    Ciudad de México |

    Cebu Province :

    Cebu City |

    Philippines :

    Manila |

    Mazovia :

    Warsaw |

    Remote :

    Remote - Middle East | Remote | Switzerland | Remote, USA | Remote - Europe |

    Bucharest :

    Bucharest |

    Makkah :

    Riyadh | King Abdullah Economic City | Khulais | Rabigh | Jeddah | Najran |

    Nišava District :

    Niš |

    Singapore :

    Singapore |

    South Africa :

    Midrand |

    Brazil :

    Sao paulo |

    South America :

    Argentina |

    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 |