Clinical Research Associate II – CNS/Oncology

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

📋 Description

• Assist in gathering feasibility questionnaires and collecting Confidential Disclosure Agreements (CDA) from prospective sites.

• Coordinate the shipment and receipt of study materials at study sites.

• Update and review documentation related to sites for Trial Master File (TMF) filing.

• Support field Clinical Research Associates (CRAs) in maintaining Investigator Site Files through TMF reconciliation and quality assurance.

• Conduct pre-study, study initiation, interim, remote monitoring, and close-out visits under the guidance of field CRAs or Clinical Trial Managers/Project Managers (CTM/PM).

• Assist with discussions regarding investigational product inventory alongside field CRAs and site personnel.

• Maintain consistent communication with study sites.

• Perform remote reviews of Electronic Data Capture (EDC) Case Report Forms (CRFs) to ensure completion, conduct logic checks, and verify data-entry compliance.

• Assist sites in resolving queries related to EDC and vendors.

• Generate study reports, maintain tracking systems, and provide relevant information to CTM and project teams.

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

• Support site staff changes, updates in Clinical Trial Management Systems (CTMS), document collection, and training assessments.

• Manage vendor access for site personnel.

• Assist with prescreening, screening, and recruitment efforts.

• Support Subject Eligibility Review tracking and assist the Medical Monitor.

• Serve as the operational point of contact for clinical research trials where applicable.

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

• Attend study meetings and present updates.

• Perform other assigned duties.

⛳️ Requirements

• Excellent oral and written communication abilities.

• Strong planning and organizational skills with effective time management.

• Good interpersonal skills.

• Capability to work in a systematic and organized manner.

• Solid understanding of clinical research principles and processes.

• Good knowledge of FDA and/or EU Directive regulations, ICH Guidelines, and local regulatory requirements.

• Familiarity with standard operating procedures.

• Basic proficiency in Microsoft Office.

• Understanding of IVRS and eCRF systems.

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

• At least two years of experience in clinical research.

• Experience in both Oncology and CNS/Neurology fields.

🏝️ Benefits

• Competitive benefits package based on location.

• An inclusive and equitable work environment.

• Transparent compensation and pay equity.