Job Description

Job Description

Job Title: Clinical Research Coordinator

Shift: Day, Monday – Friday, 08:00 – 17:00 (5 × 8-hour)

Location: Los Angeles, CA 90045 (100% On-site)

Pay Rate: $45/hr - $48/hr

About Cogent Infotech

At Cogent Infotech, we believe in creating opportunities that empower individuals and transform organizations. With over 21 years of excellence in consulting and talent solutions, we pride ourselves on building inclusive workplaces and driving innovation in everything we do. Our diverse teams bring unique perspectives to help deliver cutting-edge solutions to global clients across both public and private sectors.

Role Overview

The Clinical Research Coordinator will provide expertise and coordination for the planning, implementation, and oversight of clinical research projects at the institutional/departmental level. This role involves working closely with Principal Investigators, sponsors, regulatory bodies (e.g., IRB), and the research team to ensure high-quality, compliant, and timely execution of studies across all phases (I-IV and investigator-initiated).

Primary Duties & Responsibilities

• Provide clinical research expertise by participating in the design and implementation of research projects and supporting the care of research patients as needed.
• Lead and coordinate specific components of the research infrastructure development and/or maintenance (protocols, systems, workflows).
• Act as coordinator for departmental or institutional research projects; serve as an internal consultant for specific research activities.
• Communicate project status, key findings, and areas for improvement to leadership in a timely manner. Projects may include, but are not limited to: investigator-initiated protocol development, case report form (CRF) development, budget development, and coordination of departmental research committees.
• Implement and coordinate department-wide initiatives such as research quality management programs or clinical trial recruitment efforts.
• Provide guidance and operational oversight on project planning, logistics, and implementation across studies.
• Participate in required training and education programs; attend weekly research staff meetings.
• Provide clinical expertise and support related to quality assurance, performance improvement, and health-plan compliance for clinical trial conduct.
• Ensure the completion, maintenance, and accuracy of consent forms, CRFs, serious adverse events (SAEs), and source documents to ensure research is conducted in accordance with applicable regulations (e.g., FDA, HSPC, HIPAA) and internal policies.
• Complete the appropriate IRB/ethics-submission paperwork and coordinate submission/filing of internal and external SAEs to the IRB. Ensure timely submission of complete, accurate, and well-organized documents to sponsors, IRB, and CROs, where applicable.
• Act as liaison with Principal Investigators, pharmaceutical company representatives, and other funding or oversight organizations to monitor and update project progress.
• Prepare for institutional, sponsor, and internal audits, including facilitating third-party study monitoring.
• Attend site feasibility visits and site-initiation visits for potential new studies, ensuring that new studies are implemented according to protocol and institutional standards.
• Review pertinent medical records and analyze quality metric data in support of the Principal Investigator and Director of Clinical Services; recommend and implement process improvement efforts.
• Assist with research-related patient care procedures and support during data collection processes, when required.

Required Qualifications

• Minimum 5 years of experience in clinical research.
• Minimum 5 years of experience in IRB/ethics-committee application procedures for clinical research.
• Minimum 5 years of experience across Phase I, II, III, IV clinical trials and investigator-initiated trials.
• Ability to work independently under general direction, set and achieve goals, and maintain timelines.
• Strong analytical and problem-solving skills, including familiarity with statistical methods.
• Excellent communication skills, with the ability to engage stakeholders at all levels and translate business/scientific requirements into actionable research plans.
• Solid knowledge of data-warehouse concepts, data structures, and reporting (within a clinical research context).
• Demonstrated understanding of best practices in reporting, workflows, policies, procedures, systems, and culture in a healthcare/clinical -trial environment.

Preferred Qualifications

• Bachelor’s degree in life sciences, health sciences, pharmacy, nursing or a related field.
• Experience working in the pharmaceutical/biotechnology industry or a Contract Research Organization (CRO).

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