Senior Cra - Sponsor Dedicated

2+ years

Not Disclosed

Remote - Europe

10 Sept. 9, 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, 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

Senior Clinical Research Associate I

Syneos Health® is a fully integrated biopharmaceutical solutions organization, driven to accelerate the success of our customers by combining clinical, medical affairs, and commercial expertise to address the needs of today's healthcare market. Our Clinical Development model focuses on placing both the customer and the patient at the center of everything we do. We are committed to simplifying and streamlining our processes, making Syneos Health not only easier to work with but also a rewarding place to build your career.

Join our global team of 29,000 employees across 110 countries, where Work Here Matters Everywhere.

Why Syneos Health: At Syneos Health, we are passionate about developing our people through career progression, training in technical and therapeutic areas, and fostering a supportive and engaged work environment. Our Total Self culture allows you to bring your authentic self to work, building an inclusive atmosphere where everyone feels they belong. We continually work towards creating a diverse and dynamic workplace that our employees and customers want to be a part of.

Key Responsibilities:

Conduct site qualification, initiation, interim monitoring, site management, and close-out visits (on-site or remotely), ensuring compliance with ICH-GCP, Good Pharmacoepidemiology Practice (GPP), and regulatory protocols.
Evaluate site and staff performance, provide recommendations, escalate serious issues, and develop action plans to resolve them.
Ensure informed consent processes are adequately performed and documented for each subject/patient, maintaining confidentiality and prioritizing patient safety.
Conduct Source Document Review of site medical records, verify clinical data accuracy in case report forms (CRFs), and drive query resolution within agreed timelines.
Manage investigational product (IP) inventory, ensuring compliance with protocol requirements, storage, security, and labeling.
Review and reconcile the Investigator Site File (ISF) with the Trial Master File (TMF), ensuring accuracy and compliance with archiving regulations.
Support patient recruitment, retention, and data entry, tracking all site activities and project observations.
Serve as a liaison with site personnel and project teams, ensuring sites and staff are trained and compliant with requirements.
Lead and attend investigator meetings, clinical staff meetings, and training sessions.
Contribute to audit readiness, site-level project support, and mentorship for junior CRAs.

Additional Responsibilities for Real World Late Phase (RWLP) Studies:

Provide site support from identification to close-out.
Participate in chart abstraction activities and data collection.
Collaborate with sponsors, affiliates, medical science liaisons, and local staff.
Develop informed consent forms and work with regulatory teams to implement updated guidelines.
Identify operational efficiencies and support process improvements.
Participate in bid defense meetings.

Qualifications:

Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
Strong knowledge of Good Clinical Practice (GCP), ICH Guidelines, and regulatory requirements.
Proficiency in technology and software supporting clinical study data review.
Excellent communication, presentation, and interpersonal skills.
Ability to manage up to 75% travel on a regular basis.

Why Syneos Health: At Syneos Health, we have worked on 94% of all Novel FDA-Approved Drugs and 95% of EMA-Authorized Products over the last five years. With over 200 studies conducted at 73,000 sites and 675,000+ trial patients, we provide an unparalleled platform for professional growth.

Join our Talent Network to stay connected with future career opportunities, and take the initiative to challenge the status quo with us. Learn more about Syneos Health and discover a workplace where your career can truly thrive.

Additional Information: This job description is not exhaustive, and other tasks may be assigned at the company’s discretion. Qualifications may differ based on equivalent experience or skills. Syneos Health is committed to complying with the Americans with Disabilities Act and providing reasonable accommodations when necessary.

Apply now or join our Talent Network to explore more opportunities at Syneos Health.

Latest Jobs

Clinical Research Associate I (Clinical Trial Or Medical Field Experience Required)

Syneos Health

Remote

Stat Programmer Ii

Syneos Health

India

Principal Clinical Programmer (Veeva /Rave)

Syneos Health

Hyderabad India

Senior Statistical Programmer(Sdtm)- Hybrid (Hyderabad /Gurugram)

Syneos Health

Hyderabad

Sr. Therapeutic Specialist, Hcv/Pbc - Sacramento/Reno

Gilead

United States

Intern – Corporate Affairs & Legal - Intellectual Property

Gilead

United States

Pharma Jobs in India

Gujarat :

Maharashtra :

Haryana :

Andra Pradesh :

Tamil Nadu :

Himachal Pradesh :

Baddi | Solan |

Rajasthan :

Karnataka :

Punjab :

Madhya Pradesh :

Odisha :

Bhubaneswar | Rourkela |

Chhattisgarh :

Bilaspur | Eot Municipality | Raipur |

Uttarakhand :

Delhi :

Delhi | India | New Delhi | PAN-India |

Assam :

Dibrugarh | Diburghar | Guwahati |

West Bengal :

Digha | Kolkata | Mukundapur |

Uttar Pradesh :

Goa :

Goa | Panaji | Verna |

Bihar :

Hajipur | Patna |

Kerala :

Pondicherry (Puducherry) :

Pondicherry (Puducherry) |

Jharkhand :

Ranchi |

Sikkim :

Rangpo |

India :

Siliguri |

Pharma Jobs in United States

Illinois :

Maryland :

Texas :

California :

New York :

New Mexico :

Albuquerque | Farmington | Santa Fe | Tucumcari |

Pennsylvania :

Alaska :

Massachusetts :

Wisconsin :

United states :

Georgia :

Atlanta | Augusta | Rome |

Maine :

Bangor | Brewer |

New Jersey :

Ohio :

LA :

Baton Rouge | Monroe | New Orleans |

Washington :

Oregon :

Wyoming :

Big Piney | Cokeville |

Alabama :

Birmingham |

Virginia :

Blacksburg | Charlottesville | Falls Church | Mechanicsville |

Indiana :

Bloomington | West Lafayette |

Florida :

Idaho :

Boise |

Colorado :

Boulder | Denver | Westminster |

Connecticut :

North Caroline :

Arizona :

South Carolina :

Charleston |

Kansas :

North Carolina :

Concord | Lumberton | North Carolina |

Michigan :

Detroit | Houghton Lake | Macomb | Southfield |

North Dakota :

Dickinson |

Minnesota :

Kentucky :

Edgewood | Ft MItchell | Louisville | Shelbyville |

Arkansas :

Fort Smith |

Kington :

Frank Scottile Blvd |

Missouri :

Fulton | Milan | St. Louis |

United States :

Hawai | kentucky | Sylmar | Woonsocket |

Nebraska :

Hebron | Nebraska City |

Hawaii :

Hilo | Honolulu |

Tennessee :

Knoxville | Memphis | Nashville |

Louisiana :

Lake Charles | Shreveport |

Nevada :

Las Vegas | Tonopah | Tonopsh | Virginia |

New Hampshire :

Lebanon | Macon | Manchester |

Portugal :

Lisbon | Oeiras | Portugal |

WI :

Madison | Wausau |

Republic of Mexico :

Mexico |

northeastern :

New Hampshire |

Oklahoma :

Oklahoma City |

Puerto Rico :

San Juan |

Albama :

Tuscaloosa |

D.C :

Washington |

Delaware :

Wilmington |

Pharma Jobs in Germany

North Rhine Westphalia :

Munich :

Bavaria |

Bavaria :

Brandenburg :

Berlin |

Baden-Wurttemberg :

Hesse :

Darmstadt | Marburg |

Hessen :

Frankfurt | Harveysburg |

Germany :

Germany | GErmany |

Lower Saxony :

Gottingen | Hannover | Leipzig |

Saxony Anhalt :

Halle |

Rotherbaum :

Hamburg |

Rhineland Palatinate :

Ingelheim am Rhein | Mainz |

Schleswig Holstein :

Kiel |

Berlin :

Mitte |

Mecklenburg Vorpommern :

Rostock |

Saarland :

Saarbrucken |

Pharma Jobs in Europe

Switzerland :

Basel | Zurich |

Serbia :

Belgrade | Serbia |

Hungary :

Budapest |

BULGARIA :

Bulgaria | Vedant |

Denmark :

Copenhagen | Denmark |

Europe :

Finland :

Finland |

Istanbul :

Istanbul | Turkey |

Norway :

Norway | NOrway |

Romania :

Romania |

Belgium :

Wavre |

Pharma Jobs in Ireland

Tipperary :

Ballydine |

Cork :

Brinny | Ringaskiddy |

Carlow :

Carlow |

Republic of Ireland :

Cork | Dublin | Limerick | Waterford |

Ulster :

Donegal |

Meath :

Dunboyne |

Dún Laoghaire :

Dún Laoghaire |

Galway :

Galway |

County Dublin :

Swords |

Pharma Jobs in China

Republic of China :

Beijing |

China :

China | Quarry Bay |

Liaoning :

Dalian |

Zhejiang :

Hangzhou |

Tokiyo :

Osaka | Tokyo |

Shanghai Sai :

Shanghai Shi |

Hubei :

Wuhan |

Pharma Jobs in Netherland

Capital of Netherland :

Amsterdam |

North Brabant :

Breda |

Noord Holland :

Haarlem |

South Holland :

Leiden |

Netherlands :

Netherlands |

Pharma Jobs in Australia

Remote Australia :

Arkansas | Remote Australia |

New South Wales :

Ballina | Sydney |

Republic of Western Australia :

Nedlands |

Queensland :

Queensland |

Melbourne :

South Yarra |

Pharma Jobs in United Kingdom

Surrey :

Chessington | Pirbright |

Antrim :

Larne |

Cheshire :

Runcorn |

Hertfordshire :

Welwyn |

Pharma Jobs in England

United Kingdom :

North Yorkshire :

Harrogate |

South Yorkshire :

Sheffield |

Oxfordshire :

Witney |

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

Ontario :

Canada :

Canada |

Quebec :

Montreal |

Brussels :

Brussels |

Antwerp :

Heist op den Berg |

Flemish Brabant :

Zaventem |

South America :

Peru | Argentina |

Brazil :

Sao paulo | Brazil |

Attica :

Koropi | Athens |

Greece :

Greece |

North Island :

Auckland |

New Zealand :

New Zealand |

Austria :

Austria |

Vienna :

Vienna |

Catalonia :

Barcelona |

Madrid :

Madrid |

Cebu Province :

Cebu City |

Philippines :

Manila |

Croatia :

Croatia |

Zagreb :

Zagreb |

Estonia :

Estonia | Tartu |

Harju County (Maakond) :

Tallinn |

Hà Nội :

Hanoi | Hà Nội |

Ho Chi Minh :

Ho Chi Minh City |

Italy :

Italy |

Lombardy :

Rho |

Jakarta :

Jakarta |

East Java :

Surabaya |

Japan :

Saitama | Japan |

Tokyo :

Otemachi |

North Ostrobothnia :

Oulu |

Southwest Finland (Varsinais-Suomi) :

Turku |

Remote Korea :

Remote Korea |

Republic of Korea :

Seoul |

Kazakhstan :

Almaty |

Republic of Thailand :

Bangkok |

Israel :

Remote :

Republic of Colombia :

Bogota |

Williamson :

Brentwood |

Bucharest :

Bucharest |

Buenos Aires :

Buenos Aires |

Republic of Egypt :

Cairo |

Mexico :

Ciudad de México | New Mexico |

Dubai :

Dubai |

Makkah :

Kuala Lumpur :

Kuala Lumpur |

Kyiv Oblast :

Kyiv |

Lima Region :

Lima |

France :

Lyon | Paris |

South Africa :

Midrand | South Africa |

Nišava District :

Niš |

Bohemia :

Prague |

Chile :

Santiago |

Bosnia and Herzegovina :

Sarajevo |

Singapore :

Singapore |

Sofia City :

Sofia |

Sweden :

Sweden |

Taipei :

Taipei |

Mazovia :

Warsaw |

Welcome Back

Create Account

Senior Cra - Sponsor Dedicated

Job Description

Latest Jobs

Sr. Tmf Specialist

Sr. Tmf Specialist

Senior Medical Director / Psychiatrist

Senior Medical Director/Psychiatrist

Clinical Research Associate I (Clinical Trial Or Medical Field Experience Required)

Stat Programmer Ii

Principal Clinical Programmer (Veeva /Rave)

Senior Statistical Programmer(Sdtm)- Hybrid (Hyderabad /Gurugram)

Sr. Therapeutic Specialist, Hcv/Pbc - Sacramento/Reno

Intern – Corporate Affairs & Legal - Intellectual Property

Pharma Jobs in India

Pharma Jobs in United States

Pharma Jobs in Germany

Pharma Jobs in Europe

Pharma Jobs in Ireland

Pharma Jobs in China

Pharma Jobs in Netherland

Pharma Jobs in Australia

Pharma Jobs in United Kingdom

Pharma Jobs in England