In-house Clinical Research Associate II – CNS/Neurology

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

📋 Description

• Execute site management responsibilities for studies in alignment with GCPs, relevant regulations, and SOPs.

• Assist Clinical Trial Managers and field Clinical Research Associates.

• Collaborate with project team members across various roles and departments to meet site management deliverables punctually.

• Aid in the completion of feasibility questionnaires and collection of CDAs from potential sites.

• Oversee the shipment and receipt of study materials.

• Revise and ensure the quality of site documentation for Trial Master File filing.

• Support the maintenance of Investigator Site Files, TMF reconciliation, and TMF quality assurance.

• Conduct pre-study, initiation, interim, remote monitoring, and close-out visits under supervision.

• Assist field CRAs and site staff with the management of investigational product inventory.

• Maintain communication with sites as per monitoring plans.

• Evaluate electronic data capture CRFs for completion, logical consistency, and compliance.

• Help sites resolve EDC and vendor inquiries.

• Generate study reports, maintain trackers, and supply information to CTMs for project team or sponsor utilization.

• Prepare field CRAs for visits by summarizing action items, protocol deviations, inquiries, supplies, and training requirements.

• Assist with site staff transitions, documentation, training, qualifications, and task delegation.

• Manage vendor access for site personnel.

• Facilitate prescreening, screening, and recruitment processes.

• Assist with tracking Subject Eligibility Reviews and support the Medical Monitor.

• Act as the operational point of contact for the trial when necessary.

• Mentor and train In-house CRA I and II team members.

• Attend and provide updates during study meetings.

• Carry out other assigned tasks.

⛳️ Requirements

• Excellent oral and written communication skills.

• Strong planning and organizational abilities with effective time management.

• Good interpersonal skills.

• Capability to work in an organized and systematic manner.

• Solid understanding of clinical research principles and processes.

• Familiarity with FDA and/or EU Directive regulations, ICH Guidelines, and local regulatory requirements; training will be provided by WCT.

• Knowledge of standard operating procedures; training will be provided by Worldwide Clinical Trials.

• Basic proficiency in Microsoft Office.

• Familiarity with IVRS and eCRF systems; training will be provided by Worldwide Clinical Trials.

• A minimum of a four-year college degree with a major in medical, biological, physical, health, pharmacy, or related science.

• At least two years of clinical research experience (e.g., study coordinator, research nurse, etc.).

• Experience in CNS/Neurology.

🏝️ Benefits

• Competitive benefits package, depending on location.

• Transparent compensation and pay equity.