CRA II/Sr CRA - Oncology(Homebased US only).

Syneos Health • Orange, CA

2d • Remote

About The Position

Syneos Health is seeking a CRA II/Sr CRA for oncology clinical studies in a home-based U.S. role. This posting is intended for a possible upcoming opportunity, rather than a currently live role; interested candidates may be added to the company’s talent pipeline. The position performs clinical site monitoring and management throughout the study lifecycle, either on-site or remotely, ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP), protocol, and company-process compliance. The CRA evaluates site performance, escalates serious issues, develops action plans, and helps protect participant safety, confidentiality, and clinical data integrity.

The role involves reviewing source documents and medical records, verifying case report form data, resolving queries, checking electronic data capture compliance, and maintaining accurate site and trial documentation. It may include investigational product oversight, site file and trial master file reconciliation, support for recruitment and retention, and coordination with site personnel and project teams. The CRA also supports training, investigator meetings, audit readiness, and delivery of site-level activities within project scope and timelines. For Real World Late Phase work, responsibilities may include site support from identification through close-out, chart abstraction and data collection, collaboration with sponsor affiliates and local staff, and helping train junior staff.

The position requires regular travel of up to 75%. The posting describes a home-based U.S. role and notes that site access may require providing medical or other personal information requested by sites. Benefits may include a company car or car allowance, medical, dental and vision coverage, company 401(k) match, eligibility for performance-based commissions or bonuses, flexible paid time off, and sick time, subject to applicable requirements.

Requirements

• Bachelor’s degree or RN in a related field, or an equivalent combination of education, training, and experience.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Good computer skills and ability to embrace new technologies.
• Excellent communication, presentation, and interpersonal skills.
• Ability to manage required regular travel of up to 75%.

Responsibilities

• Perform site qualification, initiation, interim monitoring, site management, and close-out visits on-site or remotely, ensuring applicable regulatory, ICH-GCP/GPP, and protocol compliance.
• Evaluate site and staff performance, recommend site-specific actions, escalate serious issues to the project team, and develop action plans.
• Verify informed-consent processes and documentation, protect participant confidentiality, and assess risks to participant safety and clinical data integrity.
• Assess site processes and review source documents and medical records; verify clinical data entered in case report forms is accurate and complete.
• Resolve queries remotely and on-site, guide site staff, and drive query resolution to closure within agreed timelines.
• Use available hardware and software to support study data review and capture, and verify site compliance with electronic data capture requirements.
• As applicable, oversee investigational product inventory, reconciliation, storage, security, dispensing, administration, and relevant blinded or randomized information; ensure appropriate relabelling, import, release, or return.
• Review Investigator Site Files for accuracy, timeliness, and completeness; reconcile them with the Trial Master File; and ensure sites understand essential-document archiving requirements.
• Document monitoring activities through required letters, trip reports, communication logs, and other project documents; enter observations, status, and action items into tracking systems.
• Support participant recruitment, retention, and awareness strategies.
• Manage site-level activities and communications within assigned project scope, budgets, and timelines, adapting to changing priorities as needed.
• Act as a primary liaison with study site personnel or collaborate with a Central Monitoring Associate; ensure assigned sites and project-specific site team members are trained and compliant.
• Prepare for and attend investigator and sponsor meetings, project meetings, and required clinical training sessions.
• Promote audit readiness and support audit preparation and follow-up actions.
• Maintain knowledge of applicable guidance, regulations, and company procedures, and complete assigned training.
• For Real World Late Phase studies, support sites from identification through close-out, perform chart abstraction and data collection, and apply knowledge of local requirements for study designs.
• Collaborate with sponsor affiliates, medical science liaisons, and local country staff; train junior staff when requested; communicate out-of-scope activities to the Lead CRA or Project Manager; and suggest potential sites using local knowledge.

Benefits

• Company car or car allowance may be available.
• Medical, dental, and vision health benefits.
• Company-matched 401(k).
• Eligibility to earn commissions or bonuses based on company and individual performance.
• Flexible paid time off (PTO).
• Sick time, subject to applicable requirements.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level