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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)
πŸ“ Location: USA – UT – Remote (Home-Based in Western US)
πŸ†” Job ID: 25102049
πŸ“… Updated: September 25, 2025
🏒 Company: Syneos Health®


🌍 About Syneos Health

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization helping accelerate customer success.
We blend clinical, medical affairs, and commercial expertise to create outcomes that address today’s healthcare challenges.

With 29,000 employees across 110 countries, our Clinical Development model keeps both customers and patients at the center.
We continuously simplify, streamline, and innovate — making Syneos Health easier to work with and for.

WORK HERE MATTERS EVERYWHERE


πŸ’Ž Why Join Syneos Health

  • πŸš€ Career Development & Progression through technical and therapeutic training

  • 🀝 Supportive Leadership and engaged line management

  • 🌱 Total Self Culture – be your authentic self at work

  • πŸ† Recognition Programs and total rewards

  • 🌍 A diverse and inclusive environment where everyone belongs


🎯 Role Overview

The CRA II / Sr CRA (Sponsor Dedicated) is responsible for clinical monitoring and site management activities for Oncology and General Medicine studies.
The role ensures protocol compliance, GCP adherence, and regulatory accuracy while building strong site relationships and driving study success.


βš™οΈ Key Responsibilities

πŸ”Ή 1. Site Management & Monitoring

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

  • Evaluate site performance, identify issues, escalate to project team, and develop action plans.

  • Maintain strong knowledge of ICH-GCP, GPP, and company SOPs.

πŸ”Ή 2. Patient Safety & Data Integrity

  • Verify informed consent process and documentation.

  • Assess subject safety and data accuracy, identifying deviations and pharmacovigilance issues.

πŸ”Ή 3. Source Data Verification (SDV)

  • Conduct Source Document Review and verify CRF data accuracy.

  • Apply query resolution techniques and guide site staff toward closure.

  • Ensure EDC system compliance and data entry accuracy.

πŸ”Ή 4. Investigational Product (IP) Oversight

  • Perform IP inventory and reconciliation, verify storage, dispensing, and administration per protocol.

  • Ensure compliance with labeling, import/export, and return procedures.

πŸ”Ή 5. Documentation & TMF/ISF Reconciliation

  • Review and maintain Investigator Site File (ISF) accuracy.

  • Reconcile ISF with Trial Master File (TMF).

  • Support document archiving compliance.

πŸ”Ή 6. Reporting & Communication

  • Prepare confirmation letters, follow-up letters, trip reports, and communication logs.

  • Support subject recruitment and retention.

  • Maintain site tracking data and resolve action items promptly.

πŸ”Ή 7. Project Oversight

  • Understand project scope, timelines, and budgets.

  • Manage site-level communication and ensure objectives are met.

  • Adapt quickly to changing priorities.

πŸ”Ή 8. Stakeholder Collaboration

  • Act as primary liaison with site personnel and/or Central Monitoring Associate.

  • Participate in Investigator Meetings, Sponsor meetings, and training sessions.

  • Support audit readiness and respond to follow-up actions.


πŸ§ͺ Additional Responsibilities (Real World Late Phase Studies)

  • Support sites from identification through close-out.

  • Conduct chart abstraction and data collection.

  • Collaborate with Sponsor affiliates, MSLs, and local staff.

  • Train junior staff when needed.

  • Identify out-of-scope tasks and suggest potential new sites based on local knowledge.


πŸŽ“ Qualifications

βœ… Education:

  • Bachelor’s degree or RN (or equivalent combination of education, training, and experience)

βœ… Knowledge & Skills:

  • Strong knowledge of GCP/ICH Guidelines and relevant regulations

  • Excellent communication, presentation, and interpersonal skills

  • Proficient in clinical systems and technology tools

  • Flexible travel – up to 75%


πŸ‡ΊπŸ‡Έ US-Specific Requirement

  • Must provide medical/personal information if required by clinical sites for access.

  • Failure to comply with site access requirements may affect employment eligibility.


πŸ’° Compensation & Benefits

  • πŸ’΅ Base Salary Range: Varies by qualifications and experience

  • πŸš— Company Car / Car Allowance (if eligible)

  • πŸ₯ Health Benefits: Medical, Dental, Vision

  • πŸ’Ό 401(k) with company match

  • πŸ’Ή Employee Stock Purchase Plan

  • 🎯 Bonus / Commission Eligibility

  • πŸ•’ Flexible PTO & Sick Time (compliant with state/local laws)


πŸ“ˆ Syneos Health by the Numbers

  • Partnered with 94% of FDA-approved novel drugs (past 5 years)

  • Supported 95% EMA-authorized products

  • Conducted 200+ studies across 73,000 sites and 675,000+ patients

Join a global team that challenges the status quo and drives innovation in clinical research.

πŸ”— Learn more at www.syneoshealth.com


βš–οΈ Additional Information

  • Duties may evolve; additional tasks may be assigned at the company’s discretion.

  • Equivalent experience may substitute for stated qualifications.

  • Syneos Health is an Equal Opportunity Employer and complies with the Americans with Disabilities Act (ADA).

  • Reasonable accommodations available for qualified applicants.


🧭 Role Summary

  • Function: Clinical Monitoring / CRA

  • Level: Individual Contributor (may mentor juniors)

  • Focus: Site oversight, data integrity, regulatory compliance

  • Skills: Risk-based monitoring, analytics, stakeholder collaboration


🧩 Diversity & Inclusion Commitment

Syneos Health fosters a diverse, inclusive, and authentic workplace.
Even if your experience doesn’t align perfectly, apply anywaytransferable skills are valued.