CRA I – Sponsor Dedicated, Oncology, Neurology

This is a fully remote position, open to applicants in Ohio.

📋 Description

• Conduct site qualifications, initiate site visits, perform interim monitoring, manage sites, and close-out visits, either on-site or remotely.

• Ensure compliance with regulatory standards, ICH-GCP/GPP, and specific protocols.

• Assess site and staff performance, recommending tailored actions for each site.

• Identify serious issues and create action plans with the necessary guidance.

• Confirm informed consent, maintain subject/patient confidentiality, and ensure the integrity of safety and clinical data.

• Evaluate site processes according to the Clinical Monitoring/Site Management Plan.

• Execute reviews of source documents and medical records.

• Validate clinical data for case report forms and ensure compliance with electronic data capture.

• Address queries both remotely and on-site within established timelines.

• Utilize hardware and software for clinical project data review and collection.

• Oversee the inventory, reconciliation, storage, dispensing, and compliance of investigational products as applicable.

• Examine Investigator Site Files and ensure their reconciliation with the Trial Master File.

• Document monitoring activities through letters, trip reports, communication logs, and project documentation.

• Assist with strategies for subject/patient recruitment, retention, and awareness.

• Track observations, statuses, and action items until resolution.

• Manage site-level operations and communications to achieve project goals, deliverables, and timelines.

• Serve as a liaison with project site personnel, ensuring training and compliance for the site team.

• Participate in investigator, sponsor, global monitoring, and clinical training meetings.

• Facilitate audit readiness, preparation, and follow-up actions.

• For Real World Late Phase: support sites throughout the study lifecycle, conduct chart abstraction and data collection, and collaborate with sponsor affiliates, medical science liaisons, and local country staff.

⛳️ Requirements

• Bachelor’s degree or RN in a relevant field, or an equivalent combination of education, training, and experience.

• Familiarity with Good Clinical Practice/ICH Guidelines and other pertinent regulatory requirements.

• Proficient computer skills and a willingness to adopt new technologies.

• Strong communication, presentation, and interpersonal skills.

• Ability to manage travel requirements of up to 30% on a regular basis.

• Must adhere to site requests for medical and other personal information necessary for facility access in the US.

• For Real World Late Phase: understanding of local requirements for real world late phase study designs.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management team.

• Training in technical and therapeutic areas.

• Peer recognition and comprehensive rewards program.

• Potential inclusion of a company car or car allowance.

• Medical, Dental, and Vision health benefits.

• Company-matched 401(k).

• Eligibility for commissions or bonuses based on company and individual performance.

• Flexible paid time off (PTO).

• Sick leave.