Cra Ii / Sr Cra - Sponsor Dedicated - Oncology + Gen Med (Home-Based In Western Us)

0-2 years

Not Disclosed

Remote, USA

10 Oct. 2, 2025

Job Description

Job Type: Full Time Remote 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

🧾 Job Title

CRA II / Sr CRA – Sponsor Dedicated (Oncology + General Medicine)
📍 Location: USA – CA – Remote
🗓 Updated: September 25, 2025
🆔 Job ID: 25102049

🏢 About Syneos Health

Syneos Health® is a global, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success.
We transform clinical, medical affairs, and commercial insights into outcomes that address modern healthcare challenges.

Our Clinical Development Model places patients and customers at the center, ensuring innovation, agility, and speed in delivering therapies that change lives.

With 29,000 employees across 110 countries, Syneos Health offers a collaborative and inclusive environment where:

“Work Here Matters Everywhere.”

🌟 Why Work with Us

🚀 Career Development: Continuous learning, progression, and technical/therapeutic training
💬 Supportive Leadership: Engaged line managers and peer recognition programs
🧘 Total Self Culture: Encouraging authenticity, diversity, and inclusion
🌍 Global Belonging: Diversity of thoughts, cultures, and perspectives makes everyone feel valued

We’re building the company we all want to work for — and one that our customers want to work with.

🎯 Job Responsibilities

🔹 Clinical Monitoring & Site Management

Conduct site qualification, initiation, interim monitoring, site management, and close-out visits (on-site or remote)
Ensure compliance with ICH-GCP, Good Pharmacoepidemiology Practice (GPP), regulations, and protocols
Evaluate site/staff performance and escalate issues with action plans
Maintain deep working knowledge of ICH/GCP Guidelines, regulatory requirements, and SOPs

🔹 Subject Safety & Data Integrity

Verify informed consent process and documentation for each subject
Protect patient confidentiality and ensure ethical compliance
Identify and assess protocol deviations, violations, and pharmacovigilance issues

🔹 Source Documentation & Data Review

Conduct Source Document Review (SDR) of site documents and medical records
Verify accuracy and completeness of data in Case Report Forms (CRFs)
Drive query resolution (on-site and remotely)
Ensure compliance with electronic data capture (EDC) requirements

🔹 Investigational Product (IP) Oversight

Perform IP inventory, reconciliation, and storage/security review
Verify IP dispensing and administration per protocol
Ensure compliance with labeling, import/export, and return/release processes

🔹 Documentation & Communication

Prepare and maintain confirmation/follow-up letters, trip reports, and communication logs
Track all observations, status, and action items in project systems
Support subject recruitment, retention, and site engagement

🔹 Project & Site Leadership

Understand project scope, budgets, and timelines
Manage site-level activities and deliverables
Serve as primary liaison with site personnel or collaborate with Central Monitoring Associates

🔹 Training, Meetings & Audit Readiness

Train and ensure compliance of all site/project team members
Attend Investigator Meetings, Sponsor meetings, and training sessions
Support audit readiness and follow-up on findings

📘 Additional Responsibilities (Real World Late Phase Studies)

Support site lifecycle from identification to close-out
Conduct chart abstraction and data collection
Collaborate with Sponsor affiliates, Medical Science Liaisons (MSLs), and local staff
Train junior staff, as requested
Identify potential sites using local treatment insights and HCP networks
Report out-of-scope activities to Lead CRA/Project Manager

🎓 Qualifications

🎓 Bachelor’s degree or Registered Nurse (RN) in a related field (or equivalent experience)
📘 Strong understanding of GCP/ICH Guidelines and applicable regulations
💻 Proficient in computer systems and adaptable to new technologies
🗣 Excellent communication, presentation, and interpersonal skills
✈️ Willingness to travel up to 75% regularly

🩺 US-Only Note:
Certain sites may require medical/personal information for facility access. Compliance is mandatory for continued employment.

💰 Compensation & Benefits

Syneos Health provides a comprehensive total rewards package, including:

🚗 Company car or car allowance (where applicable)
🏥 Health benefits: Medical, Dental, Vision
💰 401(k) with company match
📈 Employee Stock Purchase Plan eligibility
🎯 Bonus/Commission opportunities based on performance
🕒 Flexible PTO & Sick Leave (compliant with federal/state regulations)

💵 Salary Range:
Base pay varies depending on skills, experience, and qualifications

🧠 Role Summary

Roles within Clinical Monitoring / CRA are responsible for:

Overseeing and ensuring integrity of clinical research studies
Conducting remote and on-site monitoring to verify regulatory and protocol compliance
Using data analytics and risk-based monitoring to identify issues
Collaborating with site teams to enhance quality, compliance, and process efficiency

This is an individual contributor role that may also direct or mentor junior professionals, contributing to project design, implementation, and delivery.

🌐 About Syneos Health (Quick Facts)

Worked with 94% of all FDA Novel Drug Approvals in past 5 years
Partnered in 95% of EMA Authorized Products
Conducted 200+ studies across 73,000 sites
Supported over 675,000 trial patients globally

🔗 Learn more: www.syneoshealth.com

⚖️ Equal Opportunity & Compliance

Syneos Health is committed to:

🤝 Equal Employment Opportunity (EEO)
💼 ADA Accommodations for applicants/employees
🌍 Diversity, Inclusion, and EU Equality Directive compliance

📩 How to Apply

✅ Apply Now
or
💼 Join Our Talent Network to stay updated on future opportunities.

💡 Even if your experience isn’t a perfect match, we encourage you to apply — we value transferable skills and diverse perspectives.

Latest Jobs

Clinical Project Manager (Freelance Position) - Extensive Experience In Lung, Breast Or Gastro Oncology Or Radiopharmaceuticals Required

Ergomed

Remote

Senior Vice President, Marketing

Ergomed

Remote

Site Contracts Manager

Ergomed

Remote

Pv Officer, Team Lead/Case Processing Manager (Pharmacovigilance), Team Lead (Europe Remote/Hybrid Position)

Prime Vigilance

Remote

Senior Medical Writer I (Line Management Experience Required)

Prime Vigilance

Bucharest

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 :

Athens | Koropi |

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 :

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 |

Cra Ii / Sr Cra - Sponsor Dedicated - Oncology + Gen Med (Home-Based In Western Us)

Job Description

Latest Jobs

Pharmacovigilance Officer, Team Leader (Line Management Position)

Pharmacovigilance Officer, Team Leader (Line Management Position)

Pharmacovigilance Officer, Team Leader (Line Management Position)

Executive Vice President, Pv Operations (East Coast)

Senior Site Contracts Manager

Clinical Project Manager (Freelance Position) - Extensive Experience In Lung, Breast Or Gastro Oncology Or Radiopharmaceuticals Required

Senior Vice President, Marketing

Site Contracts Manager

Pv Officer, Team Lead/Case Processing Manager (Pharmacovigilance), Team Lead (Europe Remote/Hybrid Position)

Senior Medical Writer I (Line Management Experience Required)

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 Australia

Pharma Jobs in Netherland

Pharma Jobs in England

Pharma Jobs in United Kingdom