• Login / Signup
    • Instagram
    youtube
    Facebook

    Clinical Research Associate Ii - Sponsor Dedicated

    Syneos Health
    1+ years
    Not Disclosed
    Remote, USA
    10 July 26, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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

    Company: Syneos Health®

    Location: Remote / Flexible

    About Syneos Health:
    Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We leverage unique clinical, medical affairs, and commercial insights to address modern market challenges. Our Clinical Development model centers around the customer and the patient, striving to simplify and streamline processes to enhance both client and employee experiences. Join our 29,000 employees across 110 countries and discover why working here matters everywhere.

    Why Syneos Health?

    • Career Growth: We are committed to the professional development of our people through career progression opportunities, supportive management, technical training, and recognition programs.
    • Inclusive Culture: Our Total Self culture fosters an environment where you can be your authentic self. We believe that diversity of thought, background, and perspective creates a workplace where everyone feels they belong.
    • Continuous Improvement: We are dedicated to building a company where employees thrive and customers succeed by bringing together diverse viewpoints to drive innovation.

    Job Responsibilities:

    • Site Management: Conduct site qualification, initiation, interim monitoring, management, and close-out visits (both on-site and remotely). Ensure compliance with regulatory standards, ICH-GCP, and/or Good Pharmacoepidemiology Practice (GPP) guidelines. Evaluate site performance, address serious issues, and develop action plans.
    • Informed Consent: Verify that informed consent processes are performed and documented properly, ensuring confidentiality and assessing factors affecting subject safety and data integrity.
    • Clinical Monitoring:
      • Assess site processes and conduct Source Document Reviews.
      • Verify accuracy and completeness of clinical data in case report forms (CRFs).
      • Resolve queries and provide guidance to site staff.
      • Ensure compliance with electronic data capture requirements.
    • Investigational Product (IP) Management: Oversee IP inventory, reconciliation, and verify protocol compliance for dispensing and administration. Ensure appropriate labeling, importation, and handling of IP.
    • Documentation: Maintain and reconcile Investigator Site File (ISF) and Trial Master File (TMF). Ensure proper archiving of essential documents.
    • Reporting: Document activities in confirmation letters, trip reports, and communication logs. Support recruitment, retention, and awareness strategies.
    • Project Management: Understand project scope, budgets, and timelines; manage site-level activities to meet project objectives. Adapt to changing priorities.
    • Site Liaison: Act as primary liaison with study site personnel and ensure compliance with requirements. Prepare for and attend Investigator and sponsor meetings.
    • Audit Readiness: Provide guidance for audit preparation and follow-up actions. Maintain knowledge of ICH/GCP guidelines and complete required training.
    • Real World Late Phase (if applicable): Support site activities throughout the study lifecycle, knowledge of local requirements, and training of junior staff. Suggest potential sites based on local knowledge and collaborate with various stakeholders.

    Qualifications:

    • Bachelor’s degree or RN in a related field, or equivalent education, training, and experience.
    • Knowledge of Good Clinical Practice (GCP) and ICH Guidelines.
    • Strong computer skills and ability to embrace new technologies.
    • Excellent communication, presentation, and interpersonal skills.
    • Ability to manage up to 75% travel.

    Additional Information:

    Syneos Health offers a comprehensive benefits package including health benefits (Medical, Dental, Vision), a 401k plan with company match, an Employee Stock Purchase Plan, commissions/bonuses, and flexible paid time off. Salary ranges from $63,090 to $145,000 annually, depending on qualifications and experience. Syneos Health complies with federal, state, and municipal regulations regarding paid sick time and vaccination policies.

    Application Details:

    If your experience doesn’t align perfectly with the job description, we still encourage you to apply. We value transferable skills and diverse backgrounds. Join our Talent Network to stay connected with additional career opportunities.

    #LI-SC #LI-Remote

    Latest Jobs

    Associate Research Scientist Level Ii

    Katalyst Healthcares & Life Sciences
    Remote, USA

    Senior Quality Specialist, Sequencing

    Katalyst Healthcares & Life Sciences
    Remote, USA

    Business Analyst, Medical Affairs

    Katalyst Healthcares & Life Sciences
    Remote, USA

    Biospecimen Research Data Management Coordinator

    Indoriv Clinical Private Limited
    Kolkata

    Clinical Documents Management Specialist

    Katalyst Healthcares & Life Sciences
    Remote, USA

    Associate Medical Director - Migraine Eu

    Teva Pharmaceuticals
    Haarlem

    Qa Ra Specialist

    Katalyst Healthcares & Life Sciences
    Baltimore

    Director, Medical Affairs - Multiple Therapy Areas

    Teva Pharmaceuticals
    Harlow

    Regulatory Affairs Specialist, Medical Device

    Katalyst Healthcares & Life Sciences
    Baltimore

    Validation Lead

    Katalyst Healthcares & Life Sciences
    Remote, USA

    Pharma Jobs in India

    Andra Pradesh :

    Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | 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 | Hisar | Kurukshetra | Panchkula | Rohtak |

    Himachal Pradesh :

    Solan |

    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 |

    California :

    Brisbane | Crescent City | Davis | El Monte | Emeryville | Foster City | Fremont | Irvine | La Jolla | Los Angeles | Martinez | 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 | Stanford | Vallejo | West Valley City | Whittier | Willits |

    Colorado :

    Denver |

    Connecticut :

    Storrs |

    D.C :

    Washington |

    Florida :

    Coral Gables | Gainesville | Jacksonville | Naples | Orlando | Rueil-Malmaison | Tallahassee | Tampa | West Palm Beach |

    Georgia :

    Atlanta |

    Hawaii :

    Honolulu |

    Illinois :

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

    Indiana :

    Bloomington | West Lafayette |

    Kansas :

    Lawrence |

    LA :

    Monroe | New Orleans |

    Maryland :

    Baltimore | Elkridge | Rockville |

    Massachusetts :

    Boston | Cambridge | Medford and Somerville | Rockland |

    Minnesota :

    Minneapolis and St. Paul, Minnesota. |

    Missouri :

    Fulton | St. Louis |

    New Jersey :

    Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | 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 York :

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

    North Carolina :

    Concord |

    North Caroline :

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

    Ohio :

    Columbus, |

    Oregon :

    Bend | Corvallis | Eugene | Roseburg | Springfield |

    Pennsylvania :

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

    Portugal :

    Lisbon |

    Puerto Rico :

    San Juan |

    Republic of Mexico :

    Mexico |

    Tennessee :

    Nashville |

    Texas :

    Austin | Dallas | Houston | Richardson |

    Virginia :

    Blacksburg | Charlottesville | Falls Church |

    Washington :

    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 |

    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

    Denmark :

    Copenhagen |

    Hungary :

    Budapest |

    Istanbul :

    Turkey |

    Serbia :

    Belgrade |

    Switzerland :

    Basel | Zurich |

    Pharma Jobs in China

    Hubei :

    Wuhan |

    Republic of China :

    Beijing |

    Shanghai Sai :

    Shanghai Shi |

    Tokiyo :

    Osaka | Tokyo |

    Pharma Jobs in Australia & Canada & Colombia & Croatia & Egypt & England & Indonesia & Ireland & Israel & Korea & Netherland & Remote & Saudi Arabia & Spain & Thailand

    New South Wales :

    Sydney |

    Queensland :

    Queensland |

    Republic of Western Australia :

    Nedlands |

    Quebec :

    Montreal |

    Republic of Colombia :

    Bogota |

    Zagreb :

    Zagreb |

    Republic of Egypt :

    Cairo |

    United Kingdom :

    Salt Lake City | London | Harlow |

    Jakarta :

    Jakarta |

    Republic of Ireland :

    Dublin | Limerick |

    Israel :

    Tel Aviv | Netanya | Kfar Saba |

    Republic of Korea :

    Seoul |

    Capital of Netherland :

    Amsterdam |

    Noord Holland :

    Haarlem |

    Remote :

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

    Makkah :

    Rabigh | Riyadh | Jeddah | Najran | Khulais |

    Catalonia :

    Barcelona |

    Republic of Thailand :

    Bangkok |