Clinical Research Associate

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

📋 Description

• Oversee site management and serve as the primary point of contact for the investigator and site personnel, ensuring clear and effective communication regarding enrollment status, issues, and other pertinent study details.

• Conduct various site visits including Site Evaluation, Site Initiation, Interim Monitoring, Close-out, and other study-specific visits, ensuring completion of visit reports and follow-up letters after each visit.

• Aid in the preparation of relevant training materials and deliver protocol and study-related training, including Good Clinical Practice (GCP) and regulatory requirements to assigned sites.

• Assess the quality and integrity of site practices to guarantee compliance with GCP, escalating any quality concerns as necessary.

• Oversee site and study progression by monitoring regulatory submissions, recruitment efforts, case report form (CRF) completion, and resolution of data queries.

• Ensure the collection and upkeep of essential documents, filing them appropriately in the Investigator Site File and Trial Master File.

• Instruct site staff on the correct preparation, handling, storage, and return/destruction of investigational products, verifying compliance during monitoring visits.

• Collaborate with the site to develop a patient recruitment plan, addressing challenges to enrollment and reporting the subject recruitment rate to the Clinical Project Manager.

• Confirm that written informed consent is acquired before each subject's participation in the trial.

• Ensure accuracy, completeness, and legibility of source documents, other trial records, and CRFs, verifying that CRF entries align with source data.

• Ascertain that all adverse events (AEs) are reported appropriately within the required timeframes as stipulated by GCP, the protocol, the Ethics Committees (IRB/IEC), the Sponsor, and applicable regulatory requirements.

• Document and communicate any deviations from the protocol, SOPs, GCP, and relevant regulatory standards, taking necessary actions to prevent recurrence.

• Support the coordination and execution of investigator and study meetings, including the preparation and presentation of information.

• Work collaboratively with team members in a supportive and cooperative manner to achieve study and project objectives.

⛳️ Requirements

• Experience in monitoring clinical trials involving rater-administered measures.

• Must possess experience in Central Nervous System (CNS) studies.

• Certification as a Clinical Research Associate (CCRA) is preferred.

• Proactive approach in identifying areas for improvement to enhance efficiency within Clinical Operations.

• Strong knowledge of the clinical research field, GCP, and ICH-E6 is essential.

• Exceptional interpersonal skills are required.

• Proficient in systems (CTMS, EDC, eTMF) and MS Office (Word, Excel, Outlook).

• The CRA must be capable of collaborating closely with cross-functional colleagues in a small company, demonstrating innovative thinking, analytical skills, a strong sense of responsibility, accountability, and integrity.

• Bachelor's degree in a scientific discipline, pharmacy, RN, or BSN, or a combination of education and experience that is equivalent.

• A minimum of 2 years of relevant experience within the CRO/biotech/pharmaceutical industry, including both on-site and remote monitoring experience.

🏝️ Benefits

• Health insurance

• 401(k) matching

• Flexible working hours

• Paid time off