CRA I - Sponsor Dedicated | Oncology / Neurology (Home-Based - Cleveland / Columbus, OH)

Syneos Health • USA-OH-Remote, OH

3d • Remote

About The Position

Syneos Health is recruiting for a CRA I role dedicated to oncology and neurology clinical studies, with home-based work in the Cleveland or Columbus, Ohio area. The role performs clinical site qualification, initiation, interim monitoring, site management, and close-out activities, either on-site or remotely, to help ensure regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices, and protocol compliance. The CRA evaluates site and staff performance, escalates serious issues, and helps develop action plans with guidance from the Lead CRA.

The position protects participant confidentiality and safety, reviews source records and clinical data, supports query resolution and electronic data capture, and checks investigational product handling where applicable. It maintains and reconciles site and trial documentation, records monitoring activities, supports participant recruitment and retention, and tracks site actions. The CRA manages assigned site-level activities and communications to meet project objectives and timelines, trains site personnel, participates in meetings and training, and supports audit readiness.

For Real World Late Phase assignments, the CRA I uses the business card title Site Management Associate I and may support sites throughout the study lifecycle, perform chart abstraction and data collection, apply knowledge of local requirements, and collaborate with sponsor affiliates, medical science liaisons, and local country staff. This posting is intended for a possible upcoming opportunity and adds interested candidates to Syneos Health's talent pipeline rather than advertising a live role.

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 30% on a regular basis.

Responsibilities

• Conduct site qualification, initiation, interim monitoring, site management, and close-out visits on-site or remotely, ensuring regulatory, ICH-GCP and/or GPP, and protocol compliance.
• Evaluate site and staff performance, communicate or escalate serious issues to the project team, and develop action plans with guidance.
• Verify informed consent procedures and documentation, protect participant confidentiality, and assess risks to participant safety and clinical data integrity.
• Assess site processes in accordance with the Clinical Monitoring/Site Management Plan.
• Review source documents and medical records, verify clinical data entered in case report forms, and drive query resolution within agreed timelines.
• Use hardware and software to support clinical project data review and capture, and verify site compliance with electronic data capture requirements.
• Where applicable, conduct investigational product inventory and reconciliation, review its storage and security, and verify dispensing and administration in accordance with the protocol.
• Review the Investigator Site File for accuracy, timeliness, and completeness; reconcile it with the Trial Master File; and ensure sites understand essential-document archiving requirements.
• Document monitoring activities using 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 assigned site-level activities and communications to meet project scope, objectives, deliverables, and timelines, adapting to changing priorities with oversight from the Lead CRA.
• Act as a primary liaison with site personnel or collaborate with another CRA or Central Monitoring Associate; ensure assigned sites and project-specific site team members are trained and compliant.
• Prepare for and attend Investigator Meetings and sponsor meetings, participate in project staff meetings, and attend required clinical training.
• Promote audit readiness and support audit preparation and follow-up actions.
• For Real World Late Phase assignments, support sites from identification through close-out, perform chart abstraction and data collection, apply knowledge of local requirements, and collaborate with sponsor affiliates, medical science liaisons, and local country staff.

Benefits

• Company car or car allowance may be available.
• 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 (PTO) and sick time, subject to applicable location requirements.

What This Job Offers

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