• Login / Signup
    • Instagram
    youtube
    Facebook

    Clinical Research Associate Ii

    Icon
    2+ years
    Not Disclosed
    Romania
    10 Nov. 26, 2024
    Job Description
    Job Type: Remote Education: B.A./B.S. 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

    Position: Clinical Research Associate 2 (CRA 2)
    Location: Bucharest, Romania (Flexible Hybrid Role)

    Join ICON plc, the world’s largest and most comprehensive clinical research organization, and advance your career in a sponsor-dedicated role that empowers you to impact global healthcare development.

    Key Responsibilities

    As a CRA 2, you will be responsible for managing clinical study sites and ensuring compliance with regulatory and sponsor requirements throughout the clinical trial process:

    • Site Relationship Management:

      • Build and maintain strong relationships with investigative sites across all trial phases.
      • Serve as the key point of contact for site staff on study-related matters.

    • Monitoring Activities:

      • Conduct on-site and remote monitoring visits, including validation, initiation, monitoring, and close-out visits.
      • Document clear, comprehensive, and timely visit reports.

    • Regulatory Compliance:

      • Ensure study activities comply with ICH-GCP, Sponsor SOPs, local regulations, protocols, and associated documents.
      • Collect, review, and monitor regulatory documentation throughout study phases.

    • Performance and Quality Oversight:

      • Address and resolve site performance and compliance issues.
      • Conduct root cause analysis and implement corrective/preventative measures.

    • Collaboration and Knowledge Sharing:

      • Work with cross-functional teams such as operations, regulatory affairs, and pharmacovigilance.
      • Act as a Subject Matter Expert (SME), mentor, or buddy to junior CRAs.

    • Audit Support:

      • Assist or lead preparation and participation in audit/inspection activities.
      • Perform co-monitoring visits when required.

    Qualifications and Skills

    • Education:

      • Bachelor’s degree in science, biology, or a related field (preferred).

    • Experience:

      • At least 2 years of direct site monitoring experience within a pharmaceutical, biotechnology, or CRO environment.

    • Core Competencies:

      • Strong knowledge of Good Documentation Practices (GDP).
      • Proven skills in site management, including recruitment and retention strategies.
      • Analytical mindset with the ability to understand and interpret data/metrics.
      • Proficiency in IT tools and clinical trial systems (CTMS, eTMF, etc.).

    • Personal Attributes:

      • Solution-oriented approach to complex challenges.
      • Effective communication and interpersonal skills.
      • Ability to manage multiple priorities and deliver high-quality results.

    Benefits of Working at ICON

    ICON is dedicated to nurturing talent and ensuring employee well-being:

    • Work-Life Balance:

      • Flexible working arrangements and generous annual leave entitlements.
      • Hybrid work setup with occasional on-site days.

    • Health and Wellness:

      • Comprehensive health insurance plans tailored to individual and family needs.
      • Global Employee Assistance Program (TELUS Health) for 24/7 support.

    • Financial Planning:

      • Competitive retirement plans to maximize long-term savings.
      • Life assurance and country-specific optional benefits like gym memberships and subsidized travel passes.

    • Professional Development:

      • A culture of continuous learning and career advancement.
      • Mentorship opportunities and exposure to diverse clinical research projects.

    Why Join ICON?

    ICON is committed to creating an inclusive, innovative, and empowering workplace where employees can thrive. As part of our Diversity, Inclusion, and Belonging initiatives, we welcome candidates from all backgrounds to contribute to our mission of advancing clinical development and improving global health.

    If you’re passionate about clinical research and ready to make an impact, we encourage you to apply today!

    Visit ICON Careers to learn more about this role and other exciting opportunities.

    Latest Jobs

    Cell Therapy Qa Manager

    Takeda Pharmaceutical
    Boston

    Business Account Manager

    Takeda Pharmaceutical
    Delhi

    Director, Global Alliance Management, R&D, Oncology Therapeutic Area

    Takeda Pharmaceutical
    Boston

    Infection Preventionist (Rn)

    National Health Care Associates Inc.
    Rome

    Pharmacist Clinician Anticoagulation/Full-Time In Santa Fe, Nm

    Christus Health
    Santa Fe

    Jpc - 176180 - Drug Safety Associate In Connecticut (Remote)

    Trioptus
    Stanford

    Sme - Process Specialist

    Cognizant
    Plano

    Client Relationship Manager, Life Sciences (Raleigh, Nc)

    Cognizant
    Raleigh

    Client Relationship Manager - Life Sciences (Minneapolis)

    Cognizant
    Minneapolis and St. Paul, Minnesota.

    Life Science Qa Test Program Manager - Associate Director

    Cognizant
    Boston Chicago

    Pharma Jobs in India

    Andra Pradesh :

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

    Assam :

    Dibrugarh | Diburghar | Guwahati |

    Bihar :

    Hajipur | Patna |

    Chhattisgarh :

    Bilaspur | Raipur |

    Delhi :

    Delhi | India | New Delhi | PAN-India |

    Goa :

    Goa | Panaji |

    Gujarat :

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

    Haryana :

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

    Himachal Pradesh :

    Solan |

    India :

    Siliguri |

    Jharkhand :

    Ranchi |

    Karnataka :

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

    Kerala :

    Kannur | Kochi | Malappuram | Thiruvananthapuram |

    Madhya Pradesh :

    Dewas | Gwalior | Indore | Khandwa | Khargone | Ujjain |

    Maharashtra :

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

    PAN-India :

    Panjab :

    Punjab :

    Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |

    Rajasthan :

    Banasthali | Jaipur | Pilani | Udaipur |

    Tamil Nadu :

    Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | 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 :

    Kolkata | Mukundapur |

    Pharma Jobs in United States

    Alabama :

    Birmingham |

    Alaska :

    Anchorage | Barrow | Bethel | Juneau | Wrangell |

    Arizona :

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

    Arkansas :

    Fort Smith |

    California :

    Alameda | Brisbane | California | Crescent City | Davis | El Monte | El Segundo | Emeryville | Foster City | Fremont | Glendale | Irvine | La Jolla | Los Angeles | Martinez | Menlo Park | Mountain View | Nevada | Oakland | Pacheco | Palo Alto | Pasadena | Pleasanton | 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 | Vallejo | West Valley City | Whittier | Willits |

    Colorado :

    Denver |

    Connecticut :

    Bridgeport | Enfield | Groton | Storrs |

    D.C :

    Washington |

    Florida :

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

    Georgia :

    Atlanta | Rome |

    Hawaii :

    Honolulu |

    Illinois :

    Abbott Park | Champaign | Chicago | Deerfield | Lake Forest | Lombard | Naperville | Park RIdge | Round Lake |

    Indiana :

    Bloomington | West Lafayette |

    Kansas :

    Garden city | Lawrence |

    Kenlucky :

    Shelbyville |

    Kington :

    Frank Scottile Blvd |

    LA :

    Monroe | New Orleans |

    Louisiana :

    Lake Charles | Shreveport |

    Maryland :

    Baltimore | Elkridge | Gaithersburg | Rockville |

    Massachusetts :

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

    Michigan :

    Detroit | Houghton Lake |

    Minnesota :

    Minneapolis and St. Paul, Minnesota. | St.Paul |

    Missouri :

    Fulton | St. Louis |

    Nevada :

    Las Vegas |

    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 | 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 :

    Santa Fe |

    New York :

    Albany | Biddle | Buffalo | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Rensselaer | Syracuse |

    North Carolina :

    Concord | Lumberton | North Carolina |

    North Caroline :

    Chapel Hills | Durham | Morrisville | Philippines | Raleigh | Sanford | Scottsdale |

    North Dakota :

    Dickinson |

    Ohio :

    Cincinnati | Cleveland | Columbus, | Macedonia |

    Oklahoma :

    Oklahoma City |

    Oregon :

    Bend | Coquille | Corvallis | Eugene | Roseburg | Salem | Springfield |

    Pennsylvania :

    Ambler | Collegeville | Lancaster | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | West Chester | Wyomissing |

    Portugal :

    Lisbon | Portugal |

    Puerto Rico :

    San Juan |

    Republic of Mexico :

    Mexico |

    South Carolina :

    Charleston |

    Tennessee :

    Nashville |

    Texas :

    Abilene | Austin | Bulverde | Corsicana | Dallas | Houston | Longview | Plano | Richardson | San Antonio | Tyler | Waco |

    United states :

    Georgia | United States |

    United States :

    Hawai | Sylmar |

    Virginia :

    Blacksburg | Charlottesville | Falls Church |

    Washington :

    Bothell | Goldendale | Pullman | Seattle |

    WI :

    Madison | Wausau |

    Wisconsin :

    Wyoming :

    Cokeville |

    Pharma Jobs in Germany

    Baden-Wurttemberg :

    Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |

    Bavaria :

    Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |

    Berlin :

    Mitte |

    Brandenburg :

    Berlin |

    Germany :

    Germany | GErmany |

    Hesse :

    Marburg |

    Hessen :

    Frankfurt |

    Lower Saxony :

    Gottingen | Hannover | Leipzig |

    Mecklenburg Vorpommern :

    Rostock |

    Munich :

    Bavaria |

    North Rhine Westphalia :

    Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |

    Rhineland Palatinate :

    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

    Hubei :

    Wuhan |

    Republic of China :

    Beijing |

    Shanghai Sai :

    Shanghai Shi |

    Tokiyo :

    Osaka | Tokyo |

    Pharma Jobs in Argentina & Australia & Austria & Belgium & Canada & Chile & Colombia & Croatia & Czechia & Egypt & England & Estonia & Finland & France & Greece & Indonesia & Ireland & Israel & Italy & Japan & Kazakhstan & Korea & Netherland & Philippines & Portugal & Remote & Saudi Arabia & Singapore & South Afrcia & South America & Spain & Taiwan & Tennessee & Thailand & Turkey & United Arab Emirates

    Buenos Aires :

    Buenos Aires |

    New South Wales :

    Sydney |

    Queensland :

    Queensland |

    Republic of Western Australia :

    Nedlands |

    Austria :

    Austria |

    Antwerp :

    Heist op den Berg |

    Brussels :

    Brussels |

    Canada :

    Canada |

    Ontario :

    Richmond Hill | North York |

    Quebec :

    Montreal |

    Chile :

    Santiago |

    Republic of Colombia :

    Bogota |

    Croatia :

    Croatia |

    Zagreb :

    Zagreb |

    Bohemia :

    Prague |

    Republic of Egypt :

    Cairo |

    United Kingdom :

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

    Estonia :

    Estonia |

    North Ostrobothnia :

    Oulu |

    Southwest Finland (Varsinais-Suomi) :

    Turku |

    France :

    Paris | Lyon |

    Greece :

    Greece |

    Jakarta :

    Jakarta |

    Cork :

    Ringaskiddy |

    County Dublin :

    Swords |

    Republic of Ireland :

    Waterford | Limerick | Dublin |

    Israel :

    Be'Er Sheva | Kfar Saba | Tel Aviv | Netanya |

    Italy :

    Italy |

    Tokyo :

    Otemachi |

    Kazakhstan :

    Almaty |

    Republic of Korea :

    Seoul |

    Capital of Netherland :

    Amsterdam |

    Netherlands :

    Netherlands |

    Noord Holland :

    Haarlem |

    Cebu Province :

    Cebu City |

    Philippines :

    Manila |

    Remote :

    Remote - Europe | Remote | Switzerland | Remote, USA |

    Makkah :

    Khulais | Riyadh | Rabigh | Jeddah | Najran |

    Singapore :

    Singapore |

    South Africa :

    Midrand |

    Brazil :

    Sao paulo |

    South America :

    Argentina |

    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Dubai :

    Dubai |