Cra Ii - Must Have Immuno-Inflammation Expereince - Sponsor Dedicated - Bulgaria (Homebased)

2+ years

Not Disclosed

Remote, USA

10 Nov. 20, 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

Clinical Research Associate II – Home-Based, France

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We translate unique clinical, medical affairs, and commercial insights into tangible outcomes to address modern market realities.

Our Clinical Development model places the customer and the patient at the core of everything we do. We continuously explore ways to simplify and streamline our work, not only making Syneos Health easier to work with, but also ensuring it’s an ideal place to work for our employees.

Whether you join us in a Functional Service Provider partnership or in a Full-Service environment, you’ll collaborate with passionate problem-solvers, innovating together to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies because we are passionate about making a difference in patients' lives.

Why Syneos Health?

We are committed to developing our people through career development, training, and progression. Our supportive line management, peer recognition, and rewards programs ensure you have the tools and resources needed to succeed. At Syneos Health, we embrace our Total Self culture, which encourages you to be your authentic self, creating a sense of belonging for all.

Job Responsibilities:

Site Monitoring & Management:
Perform site qualification, initiation, interim monitoring, and close-out visits (on-site or remotely), ensuring compliance with ICH-GCP, Good Pharmacoepidemiology Practice (GPP), and study protocols. Use judgment to assess site performance and escalate critical issues, developing action plans where necessary.
Informed Consent & Patient Safety:
Ensure informed consent is obtained and documented correctly for each patient, safeguarding patient confidentiality and assessing factors affecting patient safety and clinical data integrity.
Clinical Data & Compliance:
Conduct Source Document Reviews and verify the accuracy and completeness of clinical data entered into case report forms (CRFs). Apply query resolution techniques and guide site staff to resolve issues within agreed timelines.
Investigational Product (IP) Management:
Oversee IP inventory, reconciliation, storage, and security. Ensure IP is dispensed and administered according to the study protocol, and ensure appropriate labeling, importation, release, and return procedures.
Documentation & Reporting:
Document activities as required (confirmation letters, trip reports, communication logs) and track progress in data systems. Assist with recruitment, retention, and awareness strategies for patients. Ensure all site documentation complies with SOPs.
Project Coordination & Liaison:
Manage site-level activities and communication to ensure project objectives, budgets, and timelines are met. Adapt to changing priorities and serve as the primary point of contact for assigned study sites, ensuring training and compliance with project-specific requirements.
Audit Readiness & Compliance:
Maintain audit readiness, assisting in preparation for audits and ensuring follow-up actions are completed.
Real World Late Phase (RWLP) Responsibilities:
In the RWLP context, act as the Site Management Associate II, supporting the site from identification through close-out, with responsibilities that include:
- Conducting chart abstraction and data collection activities.
- Collaborating with Sponsor affiliates, medical science liaisons, and local teams.
- Proactively identifying sites based on knowledge of treatment patterns, patient advocacy, and Health Care Provider (HCP) associations.
- Providing guidance to junior staff and managing out-of-scope activities.

Qualifications:

Education: Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience.
Experience: In-depth knowledge of ICH-GCP guidelines, Good Clinical Practice, and applicable regulatory requirements.
Skills: Strong computer skills with an ability to adapt to new technologies. Excellent communication, presentation, and interpersonal abilities.
Travel: Ability to manage regular travel of up to 75%.

About Syneos Health

Over the past five years, Syneos Health has worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and has conducted over 200 studies across 73,000 sites and 675,000+ patients. Join us and take the opportunity to drive change and accelerate the delivery of therapies that make a difference to patients' lives.

Latest Jobs

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

Lilly

Richmond Hill

Pharma Jobs in India

Andra Pradesh :

Assam :

Dibrugarh | Diburghar | Guwahati |

Bihar :

Hajipur | Patna |

Chhattisgarh :

Bilaspur | Eot Municipality | Raipur |

Delhi :

Delhi | India | New Delhi | PAN-India |

Goa :

Goa | Panaji | Verna |

Gujarat :

Haryana :

Himachal Pradesh :

Baddi | Solan |

India :

Siliguri |

Jharkhand :

Ranchi |

Karnataka :

Kerala :

Kannur | Kochi | Malappuram | Thiruvananthapuram |

Madhya Pradesh :

Maharashtra :

Odisha :

Bhubaneswar | Rourkela |

PAN-India :

Panjab :

Punjab :

Rajasthan :

Sikkim :

Rangpo |

Tamil Nadu :

Uttar Pradesh :

Uttarakhand :

Dehradun | Nainital | Rishikesh |

West Bengal :

Digha | Kolkata | Mukundapur |

Pharma Jobs in United States

Alabama :

Birmingham |

Alaska :

Albama :

Tuscaloosa |

Arizona :

Arkansas :

Fort Smith |

California :

Colorado :

Denver |

Connecticut :

D.C :

Washington |

Delaware :

Wilmington |

Florida :

Georgia :

Atlanta | Rome |

Hawaii :

Hilo | Honolulu |

Idaho :

Boise |

Illinois :

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 :

Massachusetts :

Michigan :

Detroit | Houghton Lake |

Minnesota :

Missouri :

Fulton | Milan | St. Louis |

Nebraska :

Hebron | Nebraska City |

Nevada :

Las Vegas | Tonopah | Tonopsh |

New Hampshire :

Lebanon | Manchester |

New Jersey :

New Mexico :

Farmington | Santa Fe | Tucumcari |

New York :

North Carolina :

Concord | Lumberton | North Carolina |

North Caroline :

North Dakota :

Dickinson |

northeastern :

New Hampshire |

Ohio :

Oklahoma :

Oklahoma City |

Oregon :

Pennsylvania :

Portugal :

Lisbon | Portugal |

Puerto Rico :

San Juan |

Republic of Mexico :

Mexico |

South Carolina :

Charleston |

Tennessee :

Memphis | Nashville |

Texas :

United states :

fairmont | Georgia | United States |

United States :

Hawai | Sylmar |

Virginia :

Blacksburg | Charlottesville | Falls Church |

Washington :

WI :

Madison | Wausau |

Wisconsin :

Portage |

Wyoming :

Big Piney | Cokeville |

Pharma Jobs in Germany

Baden-Wurttemberg :

Bavaria :

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 :

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 :

North York | Mississauga | Uxbridge | Richmond Hill |

Quebec :

Montreal |

Chile :

Santiago |

Republic of Colombia :

Bogota |

Croatia :

Croatia |

Zagreb :

Zagreb |

Bohemia :

Prague |

Republic of Egypt :

Cairo |

South Yorkshire :

Sheffield |

United Kingdom :

Estonia :

Tartu | Estonia |

Harju County (Maakond) :

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 | 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 :

Bucharest :

Bucharest |

Makkah :

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 |

Cra Ii - Must Have Immuno-Inflammation Expereince - Sponsor Dedicated - Bulgaria (Homebased)

Job Description

Why Syneos Health?

Job Responsibilities:

Qualifications:

About Syneos Health

Latest Jobs

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

Pharmacovigilance Manager

Research Associate/ Senior Research Associate

Assoc Medical Data Review Mgr

Pharmacovigilance Services Associate

Senior Manager - Medical Affairs Professional - Obesity

Medical Affairs Professional - Oncology (Medical Advisor)

Medical Science Liaison - Biomedicines

Alliance Diabetes & Obesity Crp

Sr. Manager/Manager Medical Scientific Liaison - Oncology