Senior Clinical Research Associate

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

📋 Description

• Evaluate study protocols, Investigator Brochures, Clinical Monitoring Plans, and related documents.

• Conduct qualifications of sites, initiate studies, perform routine monitoring, and complete close-out visits.

• Assess the qualifications of investigators, site capabilities, patient demographics, and facility resources.

• Act as the main point of contact and resource for assigned investigative sites.

• Oversee source documentation, case report forms (CRFs), and electronic data capture (EDC) systems.

• Execute source data verification (SDV) and conduct source data review (SDR).

• Confirm informed consent documentation, examine subject eligibility, ensure protocol compliance, and prioritize patient safety.

• Identify, document, monitor, and follow up on protocol deviations, CAPAs, and site retraining efforts.

• Generate, review, and address data queries with investigative sites, data management teams, and study personnel.

• Examine adverse event documentation, investigational product accountability records, and additional study-related documents.

• Supervise regulatory documentation and essential study records.

• Keep study tracking tools, monitoring records, and regulatory documents up to date.

• Ensure that investigative sites have sufficient study supplies and resources.

• Liaise with site personnel concerning recruitment, enrollment, retention, and overall study progress.

• Identify issues related to site performance, compliance matters, and study risks, and communicate findings to the Project Manager and study team.

• Prepare monitoring visit reports, follow-up correspondence, and other necessary study documentation.

• Provide updates regarding study status, site performance, enrollment figures, and overall study progress.

• Participate in investigator, sponsor, and study team meetings along with training sessions.

• Assist in the development and review of CRFs, study manuals, tracking tools, and regulatory materials.

• Support the training and mentoring of CRAs and personnel from investigative sites.

• Aid in study start-up activities, site feasibility assessments, site selection, and gathering of essential documents.

• Contribute to departmental initiatives, quality improvement efforts, process enhancements, and best practices in clinical operations.

• Stay informed about industry trends, regulatory changes, and advancements in clinical research.

• Perform other assigned responsibilities, including reviewing trip reports.

⛳️ Requirements

• Bachelor's degree in Life Sciences, Nursing, or a related discipline; equivalent experience may be accepted.

• At least five (5) years of clinical monitoring experience, including direct monitoring in CNS clinical trials, within a pharmaceutical, biotechnology, contract research organization (CRO), or academic research setting.

• Proven understanding of the clinical drug development process, clinical trial execution, regulatory standards, and clinical monitoring practices.

• Strong familiarity with ICH-GCP guidelines and relevant FDA and international regulatory requirements.

• Experience with electronic data capture (EDC) systems, CTMS, eTMF systems, and clinical trial documentation processes.

• Exceptional verbal and written communication, organizational, time management, and interpersonal skills.

• Keen attention to detail with the ability to effectively prioritize and manage multiple tasks.

• Capacity to work independently while also collaborating effectively within a cross-functional team.

• Strong analytical, problem-solving, and critical-thinking abilities.

• Certified Clinical Research Associate (CCRA) certification is preferred but not mandatory.

• Willingness to travel approximately 60% to 80%, including overnight travel, as necessary to support assigned clinical studies and attend company training meetings.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health, dental, and vision insurance.

• Generous paid time off and holiday schedule.

• Opportunities for professional development and continuing education.

• Collaborative and inclusive work environment.