CRA II/Sr CRA - Ophthalmology (Homebased US only)

Syneos Health • USA-UT-Remote, UT

1d • Remote

About The Position

Syneos Health is seeking a CRA II/Sr CRA specializing in ophthalmology for a potential upcoming opportunity. This is a home-based role limited to the United States. The Clinical Research Associate conducts site qualification, initiation, monitoring, management, and close-out activities, either on site or remotely, to support compliance with regulatory requirements, ICH-GCP or applicable Good Pharmacoepidemiology Practice guidance, and study protocols. The CRA evaluates site and staff performance, addresses and escalates serious issues, and develops action plans with project teams.

The role includes reviewing consent processes, protecting participant confidentiality, assessing safety and data-integrity risks, checking source records and case report form data, resolving queries, and confirming electronic data capture compliance. The CRA may oversee investigational product accountability and handling, review and reconcile Investigator Site Files and Trial Master Files, and document monitoring activities. The CRA also supports participant recruitment and retention, tracks findings and action items, coordinates site-level work against project scope and timelines, supports site training and audit readiness, and attends investigator, sponsor, project, and training meetings.

For Real World Late Phase assignments, the CRA II may use the business card title Site Management Associate II. Additional duties can include supporting sites across the study lifecycle, chart abstraction and data collection, applying knowledge of local requirements, collaborating with sponsor affiliates and local teams, training junior staff, identifying out-of-scope activities, and suggesting potential sites based on local knowledge.

The posting is intended to build a talent pipeline for a possible future opportunity, rather than advertise a live role. The position may require travel of up to 75% on a regular basis.

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.
• Comply with site requests for medical or other personal information needed for facility access as a condition of employment; failure to provide requested information may result in denied site access and could put continued employment at risk.

Responsibilities

• Conduct site qualification, site initiation, interim monitoring, site management, and close-out visits, on site or remotely, in accordance with applicable regulations, GCP/GPP guidance, and protocol requirements.
• Evaluate site and staff performance, recommend site-specific actions, escalate serious issues, and develop action plans with the project team.
• Verify informed consent processes and documentation, protect participant confidentiality, and assess risks to participant safety and clinical data integrity.
• Assess site processes; review source documents and medical records; verify case report form data; resolve queries within agreed timelines; and confirm compliance with electronic data capture requirements.
• Use available hardware and software to support clinical study data review and capture.
• As needed, inventory and reconcile investigational product, review its storage and security, verify dispensing and administration, assess blinded or randomized information risks, and ensure appropriate labeling, 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 study activities in required letters, trip reports, communication logs, tracking systems, and other project documents.
• Support participant recruitment, retention, and awareness strategies.
• Manage assigned site-level activities and communications to meet project objectives, deliverables, budgets, and timelines; adapt to changing priorities.
• Act as a primary liaison with 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.
• Complete assigned training and maintain working knowledge of applicable guidelines, regulations, and company procedures.
• For Real World Late Phase work, support sites throughout the study lifecycle, conduct chart abstraction and data collection, collaborate with sponsor affiliates and local teams, and apply knowledge of local study requirements.
• As applicable, train junior staff, identify and communicate out-of-scope activities to the Lead CRA or Project Manager, and suggest potential sites based on local knowledge of treatment patterns, patient advocacy, and healthcare-provider associations.

Benefits

• Company car or car allowance may be included.
• Medical, dental, and vision health benefits.
• Company-match 401(k).
• Eligibility to earn commissions or a bonus based on company and individual performance.
• Flexible paid time off and sick time; paid-sick-time eligibility may vary by work location.

What This Job Offers

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