Clinical Research Associate Ii / Cra I - Sponsor Dedicated - Onc + Gen Med (Home-Based In Western Us)

1-4 years

Not Disclosed

Remote, USA

10 Nov. 19, 2025

Job Description

Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/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 / CRA I – Sponsor Dedicated (Oncology & General Medicine)

Location: Remote – Western United States (Montana)
Job ID: 25103340
Updated: November 14, 2025

Company Overview

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization focused on accelerating clinical development and improving patient outcomes globally. We combine clinical, medical affairs, and commercial expertise to deliver innovative solutions addressing modern healthcare challenges.

Our Clinical Development model centers the patient and client, continuously optimizing processes to simplify collaboration and ensure excellence in clinical trials. Team members work in Full-Service or Functional Service Provider (FSP) environments, driving innovation, efficiency, and successful therapy delivery.

Position Summary

We are seeking an experienced Clinical Research Associate II / CRA I to provide sponsor-dedicated support for Oncology (ONC) and General Medicine trials. This remote, home-based role in Montana involves monitoring trial sites, ensuring regulatory compliance, protecting patient safety, and verifying data integrity. The role requires a proactive professional capable of collaborating with cross-functional teams and mentoring junior staff when necessary.

Key Responsibilities

Conduct site qualification, initiation, interim monitoring, and close-out visits, both remotely and on-site, ensuring compliance with ICH-GCP, GPP, local regulations, and study protocols.
Evaluate site and staff performance; escalate critical issues; and implement corrective action plans.
Verify informed consent procedures and maintain patient confidentiality. Monitor safety and clinical data quality.
Perform source document verification and ensure case report forms (CRFs) are accurate and complete.
Lead query resolution processes and guide site staff to ensure timely closure.
Manage investigational product (IP) accountability, including storage, reconciliation, labeling, and adherence to blinded/randomized protocols.
Maintain Investigator Site Files (ISF) and reconcile with Trial Master File (TMF).
Document activities via trip reports, follow-ups, and other project records.
Support patient recruitment, retention, and site awareness initiatives.
Act as liaison with study site personnel and collaborate with Central Monitoring Associates.
Participate in investigator and sponsor meetings, as well as project-specific clinical training sessions.
Provide guidance on audit readiness and support audits as required.
For Real-World Late Phase studies, assist in site lifecycle support, chart abstraction, and local collaboration with sponsor affiliates.
Mentor junior staff and provide local site insights to optimize study conduct.

Qualifications & Experience

Bachelor’s degree or RN in Life Sciences, Nursing, Pharmacy, or related field.
CRA I: Minimum 1 year of clinical monitoring experience.
CRA II: Minimum 2–4 years of independent clinical monitoring experience.
Strong understanding of ICH-GCP Guidelines, SOPs, and regulatory requirements.
Proficiency with electronic data capture (EDC) systems and clinical monitoring software.
Excellent communication, presentation, and interpersonal skills.
Ability to travel up to 75%, including on-site visits.

Preferred

Experience in Oncology and General Medicine clinical trials.
Knowledge of risk-based monitoring and real-world evidence studies.
Experience mentoring junior clinical staff.

Compensation & Benefits

Competitive salary based on qualifications and experience.
Comprehensive health benefits: Medical, Dental, Vision.
401(k) match and Employee Stock Purchase Plan eligibility.
Performance-based bonus opportunities.
Flexible paid time off (PTO) and sick leave.
Company car or allowance where applicable.

Why Join Syneos Health?

Work with over 675,000 patients across 73,000 sites globally.
Engage in a diverse, inclusive, and supportive work culture.
Access career development, mentoring, and training programs.
Contribute to cutting-edge clinical research that transforms patient outcomes.

Additional Information

This description is not exhaustive. Duties may evolve, and equivalent experience or education will also be considered. Syneos Health is committed to compliance with the Americans with Disabilities Act (ADA) and provides reasonable accommodations where appropriate.

Apply Now to join a global leader in clinical research, or join our Talent Network for updates on future opportunities.

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 :

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 :

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 | Vedant |

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 |

Galway :

Galway |

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 :

Arkansas | 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 :

Chessington | 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 :

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 :

Italy :

Italy |

Lombardy :

Rho |

Japan :

Saitama | Japan |

Tokyo :

Otemachi |

Kazakhstan :

Almaty |

Remote Korea :

Remote Korea |

Republic of Korea :

Seoul |

Kuala Lumpur :

Kuala Lumpur |

Mexico :

Ciudad de México |

New Zealand :

New Zealand |

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 :

Midrand | South Africa |

Brazil :

Brazil | Sao paulo |

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 :

Hà Nội | Hanoi |

Ho Chi Minh :

Ho Chi Minh City |

Clinical Research Associate Ii / Cra I - Sponsor Dedicated - Onc + Gen Med (Home-Based In Western Us)

Job Description

Latest Jobs

Senior Statistical Data Scientist

Experienced Data Review Associate – Hyderabad, India

Clinical Data Review Associate – Navi Mumbai, India

Senior Medical Information Writer

Associate – Manufacturing Compliance

Associate Project Manager – Training And Communication

Medical Director Dme – Remote

Partner, Regulatory Affairs – Regulatory Product Information Management

Associate Quality Assurance – Mqa Downstream

Career Opportunities: Manager-Clinical Solutions Coe (10459)