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

1-2 years
Not Disclosed
10 Nov. 20, 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 – Oncology & General Medicine (Remote, Western US)

Location: USA – CA – Remote
Updated: November 14, 2025
Job ID: 25103340

Position Overview

Syneos Health, a global leader in fully integrated biopharmaceutical solutions, is seeking a Clinical Research Associate II / CRA I to support sponsor-dedicated oncology and general medicine programs across the Western United States. This remote role offers the opportunity to work within a highly collaborative, patient-focused clinical development environment designed to accelerate study delivery and support global research excellence.

Syneos Health brings together clinical, medical affairs and commercial expertise, with a presence across 110 countries and more than 29,000 employees. The organization prioritizes streamlined operations, workforce development and a culture where employees can advance, innovate and contribute meaningfully to modern clinical research.

Key Responsibilities

  • Conduct site qualification, initiation, interim monitoring, and close-out visits, on-site and remotely.

  • Ensure strict adherence to ICH-GCP, GPP, global regulatory requirements, and protocol standards.

  • Assess overall site performance, identify risks, escalate critical issues, and implement corrective action plans.

  • Verify informed consent processes and maintain subject confidentiality, identifying safety and pharmacovigilance issues.

  • Perform Source Document Review (SDR) and validate the accuracy and completeness of case report forms (CRFs).

  • Apply data review and query management techniques; utilize electronic systems for clinical data capture.

  • Support investigational product accountability, storage compliance, and secure handling procedures.

  • Maintain Investigator Site File (ISF) integrity and ensure alignment with the Trial Master File (TMF).

  • Document monitoring findings through trip reports, follow-up letters, communications, and required project documentation.

  • Contribute to strategies for subject recruitment, retention, and site engagement.

  • Track site performance metrics, progress, action items, and compliance with study timelines.

  • Serve as a liaison between study sites and the project team or central monitoring associates.

  • Participate in investigator meetings, training programs, project team discussions and sponsor interactions.

  • Provide site readiness support, audit preparation, and follow-up for required actions.

  • For Real-World/Late Phase studies: conduct chart abstraction, data collection, site support, and collaborate with medical liaisons and local affiliates.

  • Identify out-of-scope activities and recommend potential new sites based on regional insights and treatment patterns.

  • May provide training or mentorship to junior site-management staff.

Required Qualifications and Experience

  • Bachelor’s degree in a life science discipline or RN; equivalent education and experience may be considered.

  • Knowledge of ICH-GCP, applicable regulatory guidelines, and clinical monitoring principles.

  • Strong digital proficiency with clinical systems and willingness to adopt new technologies.

  • Excellent communication, presentation and interpersonal skills.

  • Ability to travel up to 75% as required by study needs.

  • Must comply with U.S. site-specific credentialing or medical clearance requirements per facility standards.

Experience Required (GPT-Optimized Clarity):

  • CRA I: Typically 1+ year of independent monitoring experience in clinical trials.

  • CRA II: Typically 2+ years of independent on-site monitoring experience, with oncology or general medicine preferred.

Why Join Syneos Health

  • Structured career development pathways, technical and therapeutic training, and supportive leadership.

  • Comprehensive recognition and rewards programs.

  • A global culture where authenticity, diversity, and professional growth are valued.

  • Competitive benefits including medical, dental, vision, 401(k) match, stock purchase eligibility, performance-based bonuses, PTO, and sick leave aligned with local regulations.

  • Opportunities to contribute to an organization that has partnered in 94 percent of FDA-approved novel drugs and 95 percent of EMA-authorized products over the past five years.

Salary Range

The base salary range reflects the anticipated minimum and maximum for this position. Actual compensation depends on experience, competencies, and job-related qualifications.

About Syneos Health

With extensive global partnerships, more than 200 studies executed across 73,000 sites, and over 675,000 clinical trial participants, Syneos Health continues to lead integrated clinical and commercial solutions. The organization is committed to high-quality research delivery and continuous improvement across operational domains.

Learn more at syneoshealth.com.

Additional Information

  • Responsibilities listed are not exhaustive and may be adjusted based on business needs.

  • Equivalent experience or education may be considered at the company’s discretion.

  • This job description complies with U.S. and international employment legislation, including the EU Equality Directive and ADA requirements for reasonable accommodations.

  • This description is not an employment contract but outlines core expectations for the role.

Summary

The Clinical Research Associate II / CRA I role is responsible for ensuring the integrity and regulatory compliance of clinical trials through risk-based monitoring, data validation, site oversight and continuous quality improvement. The position suits clinical research professionals with practical monitoring experience who can manage complex workflows, engage with investigators and support the operational success of global clinical programs.

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