Cra2 Or Sr Cra

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

About Syneos Health:

Syneos Health® is a leading integrated biopharmaceutical solutions organization that accelerates customer success by transforming clinical, medical, and commercial insights into actionable outcomes. Our focus is on putting the customer and the patient at the center of everything we do. We continuously innovate to simplify and streamline our operations, making Syneos Health both easier to collaborate with and a great place to work.

As part of our team, you'll work alongside passionate problem-solvers in an agile environment, helping our clients bring new therapies to market faster while improving lives.

Why Syneos Health?

We’re committed to developing our people by fostering career growth, providing robust training, and offering a comprehensive total rewards program. Our Total Self culture unites us across the globe, ensuring that every employee can authentically be themselves. Diversity, equity, and inclusion are key pillars that make Syneos Health a place where everyone feels they belong.

Job Responsibilities:

As a Senior Clinical Research Associate I (CRA I), your role will involve key responsibilities throughout the study lifecycle, ensuring study compliance, patient safety, and data integrity. You will:

Site Management & Monitoring:

Perform site qualification, initiation, interim monitoring, and close-out visits, both on-site and remotely, ensuring compliance with ICH-GCP, Good Pharmacoepidemiology Practice (GPP), and protocol guidelines.
Use professional judgment to assess site performance, identify issues, and provide actionable recommendations.
Escalate serious issues and work closely with the project team to develop corrective action plans.
Verify informed consent processes and ensure patient confidentiality and safety throughout the study.
Review and verify clinical data entry, ensuring accuracy and completeness through Source Document Review (SDR) and Source Data Verification (SDV).

Investigational Product (IP) Management:

Oversee IP inventory and ensure proper storage, dispensing, and administration in line with study protocols.
Ensure compliance with local regulations and GCP in the handling of blinded or randomized IP.

Site Communication & Documentation:

Ensure Investigator Site File (ISF) is complete, accurate, and reconciled with the Trial Master File (TMF).
Document monitoring activities in compliance with SOPs and Clinical Monitoring Plans (CMP).
Track all observations, action items, and site progress through tracking systems to resolution.
Support subject recruitment and retention strategies in collaboration with site teams.

Training & Mentorship:

Train and mentor junior CRAs, providing guidance on monitoring practices and site management activities.
Support audit readiness, ensuring sites comply with audit preparation standards and managing any follow-up actions.

Project & Sponsor Interaction:

Participate in Investigator Meetings and sponsor face-to-face meetings.
Lead or contribute to global clinical monitoring/project staff meetings and ensure smooth communication across study teams.
Help prepare and support audit readiness activities and audit follow-up actions.

Real World Late Phase (RWLP) Studies:

For RWLP, support activities across the study lifecycle, from site identification through to close-out.
Engage in chart abstraction activities and data collection as required by study protocols.
Collaborate with local teams to ensure compliance with regional and regulatory requirements.

Qualifications:

Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience.
Knowledge of Good Clinical Practice (GCP), ICH Guidelines, and regulatory requirements.
Proficiency with clinical monitoring tools, data capture systems, and modern technologies.
Strong communication, presentation, and interpersonal skills.
Ability to travel up to 75% for site visits and study-related activities.

Why Work at Syneos Health?

Syneos Health is proud to have contributed to 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products. We have supported over 200 studies across 73,000 sites, helping to improve the lives of more than 675,000 trial patients.

Join us and challenge the status quo while being part of a highly competitive and rapidly evolving industry.

Ready to make a difference? Apply now and help us deliver therapies that matter.

Latest Jobs

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 :

Madhya Pradesh :

Maharashtra :

Odisha :

Bhubaneswar | Rourkela |

PAN-India :

Panjab :

Pondicherry (Puducherry) :

Pondicherry (Puducherry) |

Punjab :

Rajasthan :

Sikkim :

Rangpo |

Tamil Nadu :

Uttar Pradesh :

Uttarakhand :

West Bengal :

Digha | Kolkata | Mukundapur |

Pharma Jobs in United States

Alabama :

Birmingham |

Alaska :

Albama :

Tuscaloosa |

Arizona :

Arkansas :

Fort Smith |

California :

Colorado :

Boulder | Denver | Westminster |

Connecticut :

D.C :

Washington |

Delaware :

Wilmington |

Florida :

Georgia :

Atlanta | Augusta | Rome |

Hawaii :

Hilo | Honolulu |

Idaho :

Boise |

Illinois :

Indiana :

Bloomington | West Lafayette |

Kansas :

Garden city | Kansas City | Lawrence | McPherson |

Kentucky :

Edgewood | Ft MItchell | 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 | Macomb | Southfield |

Minnesota :

Missouri :

Fulton | Milan | St. Louis |

Nebraska :

Hebron | Nebraska City |

Nevada :

Las Vegas | Tonopah | Tonopsh | Virginia |

New Hampshire :

Lebanon | Macon | Manchester |

New Jersey :

New Mexico :

Albuquerque | 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 | Oeiras | Portugal |

Puerto Rico :

San Juan |

Republic of Mexico :

Mexico |

South Carolina :

Charleston |

Tennessee :

Knoxville | Memphis | Nashville |

Texas :

United states :

United States :

Hawai | kentucky | Sylmar | Woonsocket |

Virginia :

Blacksburg | Charlottesville | Falls Church | Mechanicsville |

Washington :

WI :

Madison | Wausau |

Wisconsin :

Appleton | Pleasant Prairie | Portage | Waukesha |

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

Belgium :

Wavre |

BULGARIA :

Bulgaria |

Denmark :

Copenhagen | Denmark |

Europe :

Finland :

Finland |

Hungary :

Budapest |

Istanbul :

Istanbul | Turkey |

Norway :

Norway | NOrway |

Romania :

Romania |

Serbia :

Belgrade | Serbia |

Switzerland :

Basel | Zurich |

Pharma Jobs in Ireland

Carlow :

Carlow |

Cork :

Brinny | Ringaskiddy |

County Dublin :

Swords |

Dún Laoghaire :

Dún Laoghaire |

Meath :

Dunboyne |

Republic of Ireland :

Cork | Dublin | Limerick | Waterford |

Tipperary :

Ballydine |

Ulster :

Donegal |

Pharma Jobs in China

China :

China | Quarry Bay |

Hubei :

Wuhan |

Liaoning :

Dalian |

Republic of China :

Beijing |

Shanghai Sai :

Shanghai Shi |

Tokiyo :

Osaka | Tokyo |

Zhejiang :

Hangzhou |

Pharma Jobs in Australia

Melbourne :

South Yarra |

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 |

North Brabant :

Breda |

South Holland :

Leiden |

Pharma Jobs in England

North Yorkshire :

Harrogate |

Oxfordshire :

Witney |

South Yorkshire :

Sheffield |

United Kingdom :

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 & Estonia & Federated States of Micronesia & Finland & France & Greece & Indonesia & Israel & Italy & Japan & Kazakhstan & Korea & malaysia & Mexico & New Zealand & Peru & 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 |

Flemish Brabant :

Zaventem |

Bosnia and Herzegovina :

Sarajevo |

Sofia City :

Sofia |

Canada :

Canada |

Ontario :

Quebec :

Montreal |

Chile :

Santiago |

Republic of Colombia :

Bogota |

Croatia :

Croatia |

Zagreb :

Zagreb |

Bohemia :

Prague |

Republic of Egypt :

Cairo |

Estonia :

Estonia | Tartu |

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 :

Italy :

Italy |

Lombardy :

Rho |

Japan :

Japan | Saitama |

Tokyo :

Otemachi |

Kazakhstan :

Almaty |

Remote Korea :

Remote Korea |

Republic of Korea :

Seoul |

Kuala Lumpur :

Kuala Lumpur |

Mexico :

Ciudad de México |

North Island :

Auckland |

Lima Region :

Lima |

Cebu Province :

Cebu City |

Philippines :

Manila |

Mazovia :

Warsaw |

Remote :

Bucharest :

Bucharest |

Makkah :

Nišava District :

Niš |

Singapore :

Singapore |

South Africa :

South Africa | Midrand |

Brazil :

Sao paulo | Brazil |

South America :

Peru | 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 |

Cra2 Or Sr Cra

Job Description

About Syneos Health:

Why Syneos Health?

Job Responsibilities:

Qualifications:

Why Work at Syneos Health?

Latest Jobs

Global Clinical Development Strategy Expert - Vaccines

Global Clinical Development Strategy Expert

Clinical Trial Application (Cta) Coordinator Support (Cta-Cs)

Global Head Of Ai-Driven Innovations, Clinical Data And Ai Processing

Global Clinical Vendor Manager

Clinical Lead, I&I

Senior Clinical Research Director - Bone Marrow Transplantation

Senior Clinical Research Director, I&I

Clinical Research Director, I&I (Ibd)

Clinical Research Director