Experienced Clinical Research Associate | Regionally Aligned Across US

Syneos Health • USA-TX-Remote, NV

20d

About The Position

Syneos Health is seeking an Experienced Clinical Research Associate for a potential upcoming opportunity. The role conducts site qualification, initiation, monitoring, management, and close-out activities, either on-site or remotely, to ensure compliance with regulations, ICH-GCP or applicable GPP guidance, protocols, and company procedures. The CRA evaluates site performance, addresses risks and issues, supports subject safety and data integrity, and communicates and escalates concerns to the project team.

The position reviews informed consent, source documents, medical records, case report form data, electronic data capture compliance, investigational product handling, and essential site documentation. It supports recruitment and retention, maintains study tracking and documentation, coordinates site-level activities against project scope and timelines, and helps ensure sites and project staff are appropriately trained. The CRA also participates in investigator and sponsor meetings, supports audit readiness, and completes required training.

For Real World Late Phase assignments, the CRA II may use the business card title Site Management Associate II. Additional duties can include site support throughout the study lifecycle, chart abstraction and data collection, collaboration with sponsor affiliates and local teams, training junior staff, communicating out-of-scope activities, and suggesting potential sites based on local knowledge. The posting is for a possible future opportunity, not a currently live role; interested candidates may be added to the talent pipeline.

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 travel of up to 75% on a regular basis.

Responsibilities

• Perform site qualification, site initiation, interim monitoring, site management, and close-out visits remotely or on-site.
• Evaluate site and staff performance, recommend site-specific actions, escalate serious issues, and develop action plans.
• Verify informed consent processes and documentation, protect participant confidentiality, and assess risks to participant safety and data integrity.
• Assess site processes and review source documents, medical records, case report forms, and electronic data capture compliance.
• Resolve data queries within agreed timelines and provide guidance to site staff.
• When applicable, inventory and reconcile investigational product, review its storage and security, and verify dispensing and administration according to protocol.
• Review and reconcile the Investigator Site File and Trial Master File, and ensure sites understand document archiving requirements.
• Document study activities in required letters, reports, communication logs, and project documents; maintain tracking systems and action items.
• Support participant recruitment, retention, and awareness strategies.
• Manage site-level activities and communications to meet project objectives, deliverables, budgets, and timelines, adapting to changing priorities.
• Act as a primary liaison with study-site personnel or collaborate with a Central Monitoring Associate.
• Ensure assigned sites and site team members are trained and compliant with applicable requirements.
• Prepare for and attend investigator and sponsor meetings, project meetings, and required clinical training.
• Support audit readiness and audit preparation and follow-up.
• For Real World Late Phase work, support sites throughout the study lifecycle, perform chart abstraction and data collection, collaborate with sponsor affiliates and local staff, and suggest potential sites based on local knowledge.
• For Real World Late Phase work, train junior staff when requested and communicate out-of-scope activities to the Lead CRA or Project Manager.

Benefits

• Company car or car allowance may be included.
• Medical, dental, and vision health benefits.
• Company-matched 401(k).
• Eligibility to participate in the Employee Stock Purchase Plan.
• Eligibility to earn commissions or bonuses based on company and individual performance.
• Flexible paid time off and sick time, subject to applicable location requirements.
• Career development and progression.
• Technical and therapeutic area training.
• Peer recognition and a total rewards program.

What This Job Offers

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