Clinical Research Coordinator

Overview

• Coordinate and manage clinical research studies ensuring compliance with GCP, ICH, HIPAA, FDA regulations, and standard operating procedures.
• Collaborate with clinical research teams to ensure efficient execution of assigned studies and achieve study objectives.
• Screen and enroll patients for clinical trials, including obtaining informed consent and scheduling follow-up visits.
• Perform clinical procedures such as vital sign monitoring, ECGs, and specimen collection as per study protocols.
• Maintain accurate documentation in clinic charts, electronic data capture systems, and study-specific logs.
• Ensure timely reporting and resolution of adverse events, deviations, and non-compliance issues.
• Support study start-up activities, including training, document preparation, and attending site initiation visits.
• Maintain confidentiality of patient and company information, adhering to HIPAA guidelines and ALCOAC principles.

Key Responsibilities & Duties

• Screen patients for eligibility and manage the consent process for study enrollment.
• Conduct patient follow-up visits and ensure accurate documentation in clinic charts.
• Perform basic clinical procedures such as vital signs, ECGs, and phlebotomy as per protocol.
• Enter data into electronic data capture systems and address queries efficiently.
• Manage study-specific supplies, scheduling, and appointment reminders for subjects.
• Prepare for and attend site initiation visits and investigator meetings as required.
• Ensure timely review of study-related reports and patient results by investigators.
• Maintain effective communication with clients, team members, and external stakeholders.

Job Requirements

• Bachelor of Science (BS) degree required, with 2-3 years of clinical research experience preferred.
• Proficiency in clinical procedures such as vital signs, EKGs, and phlebotomy is highly desirable.
• Strong organizational skills, attention to detail, and ability to manage multiple tasks effectively.
• Proficiency with Microsoft applications, electronic health records, and web-based systems.
• Exceptional written and verbal communication skills for effective collaboration and reporting.
• Ability to work independently and as part of a team in a fast-paced environment.
• Knowledge of GCP, ICH, HIPAA, and FDA regulations is essential.
• Bilingual proficiency in English and Spanish is a plus.