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

0-2 years
Not Disclosed
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 – WA – Remote (Home-Based in Western US)
Updated: September 25, 2025
Job ID: 25102049
Company: Syneos Health®


🏢 About Syneos Health

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization committed to accelerating customer success.
We combine clinical, medical affairs, and commercial insights to deliver outcomes that address modern market realities.

With 29,000 employees across 110 countries, we bring the customer and patient to the center of everything we do — simplifying processes, streamlining collaboration, and transforming lives through innovative therapies.

🌍 Why Work at Syneos Health

  • Career development, training, and clear progression paths

  • Supportive and engaged leadership

  • Peer recognition and total rewards programs

  • Inclusive “Total Self” culture — authenticity, belonging, and diversity

  • A global company where your work matters everywhere


🎯 Position Summary

The Clinical Research Associate (CRA II / Sr. CRA) oversees and ensures the integrity of clinical research studies by monitoring data and processes either on-site or remotely.
You will ensure compliance with ICH-GCP guidelines, protocol requirements, and regulatory standards across Oncology and General Medicine studies.


🧩 Key Responsibilities

🔹 Site Monitoring & Management

  • Conduct site qualification, initiation, interim monitoring, and close-out visits (remote or on-site).

  • Evaluate overall site performance; identify and escalate serious issues; propose action plans.

  • Ensure adherence to protocols, ICH-GCP, GPP, and SOPs.

🔹 Subject Safety & Data Integrity

  • Verify informed consent process and documentation.

  • Assess and report potential risks to subject safety or data integrity (e.g., deviations, PV issues).

🔹 Source Data & Documentation

  • Conduct Source Document Review (SDR) and ensure CRF data accuracy.

  • Apply query resolution techniques and drive closure within agreed timelines.

  • Ensure compliance with Electronic Data Capture (EDC) systems.

🔹 Investigational Product (IP) Oversight

  • Review IP inventory, reconciliation, storage, and security.

  • Verify dispensing and administration per protocol.

  • Ensure GCP compliance for IP labeling, import, and return.

🔹 Regulatory Documentation

  • Maintain Investigator Site File (ISF) and reconcile with Trial Master File (TMF).

  • Ensure archiving compliance with local regulations.

🔹 Communication & Reporting

  • Document activities (confirmation letters, trip reports, logs).

  • Support subject recruitment and retention strategies.

  • Track observations, status updates, and action item resolutions.

🔹 Project Management

  • Understand project scope, budget, and timelines.

  • Manage site-level communication and deliverables.

  • Adapt quickly to changing priorities.

🔹 Collaboration

  • Act as primary liaison with study sites.

  • Participate in Investigator Meetings and Sponsor meetings.

  • Support audit readiness and follow-up actions.


💡 Additional Responsibilities (Real World Late Phase Studies)

  • Support sites throughout lifecycle — from identification to close-out.

  • Perform chart abstraction and data collection.

  • Collaborate with Sponsor affiliates, MSLs, and local country teams.

  • Train junior staff; identify out-of-scope activities; suggest potential sites.


🎓 Qualifications

  • Bachelor’s degree (or equivalent) in life sciences, pharmacy, nursing (RN), or related field

  • Strong knowledge of ICH-GCP and applicable regulatory guidelines

  • Proficient with clinical systems and digital tools

  • Excellent communication, presentation, and interpersonal skills

  • Willingness to travel up to 75% regularly (as required)


🧾 Additional Requirements (US Only)

  • Must comply with site access requirements (medical/personal information).

  • Non-compliance may impact employment eligibility.


💰 Compensation & Benefits

  • Competitive base salary (range depends on experience and qualifications)

  • Company car / car allowance (if eligible)

  • Health benefits: Medical, Dental, Vision

  • 401(k) with company match

  • Employee Stock Purchase Plan

  • Bonus/Commission eligibility

  • Flexible Paid Time Off (PTO) and sick leave (varies by state)


🚀 About Syneos Health Impact

  • Partnered with 94% of all Novel FDA-Approved Drugs (last 5 years)

  • 95% EMA Authorized Products supported

  • 200+ Studies, 73,000 Sites, and 675,000+ trial patients

No matter your role, you’ll challenge the status quo and innovate in a fast-paced, dynamic environment.

🔗 Learn more: www.syneoshealth.com