Clinical Research Coordinator

Overview

The Clinical Research Coordinator is accountable for overseeing daily clinical trial operations, ensuring adherence to established protocols, scope of work, and regulatory mandates. Key duties include participant recruitment and screening, precise documentation, and regular updates on participant progress. The role demands prioritization of clinical trial tasks and efficient workflow management within regulatory frameworks to maintain confidentiality and ensure compliance.

Responsibilities

• Carry out judgments within protocol guidelines and directions from supervisory clinical leadership.
• Protect participant privacy and confidentiality in compliance with FDA, ICH GCP, HIPAA, IRB, and institutional policies.
• Conduct study-related participant assessments such as informed consent, medical history, adverse event monitoring, Fibroscan, memory screening, test article management, appointment coordination, and vital signs collection.
• Manage documentation and data as per Good Clinical Practice (GCP) and regulatory standards.
• Serve as liaison for pharmaceutical sponsors and external vendors; participate in audits and monitoring visits.
• Oversee participant management from recruitment through study completion to enhance engagement and care quality.
• Respond promptly to inquiries from internal and external stakeholders.
• Identify and implement improvements for participant experience and satisfaction.
• Troubleshoot and resolve study-related issues within established timeframes collaboratively.
• Develop and sustain productive relationships with internal teams and external partners to ensure research excellence.
• Manage multiple projects with competing priorities and maintain current enrollment and study status documentation.
• Attend all required investigator and study-related meetings and visits.

Administrative Duties

• Prepare communications such as memos, emails, and letters relating to study activities.
• Maintain reports and spreadsheets as needed for study tracking and reporting.
• Assist regulatory staff with maintaining study documents and timely electronic documentation storage.
• Report safety information to regulators and conduct quality assurance checks on source documents.
• Support Corrective and Preventive Action Plans (CAPA) when necessary.

Qualifications and Experience

• Minimum of high school diploma or GED; Bachelor’s degree in a scientific discipline preferred.
• At least one year of experience as a Clinical Research Assistant or Coordinator; one to two years in clinical research overall.
• Proficiency in Microsoft Office and clinical trial management systems such as Clinical Research IO or equivalent.
• Strong knowledge of ICH/GCP guidelines; completion and maintenance of GCP training mandatory.
• Certification or training in Fibroscan and memory assessments provided as required.
• Basic Life Support (BLS) certification to be completed during onboarding.
• Excellent organizational, multi-tasking, and communication skills; knowledge of medical terminology advantageous.
• Integrity and alignment with company ethics and mission essential.
• Spanish-English bilingual skills preferred.

Work Environment and Physical Requirements

• Work conducted in office, laboratory, or clinical settings with potential exposure to biological fluids and bloodborne pathogens requiring personal protective equipment (e.g., gloves, eyewear, garments).
• Possible occasional travel domestically or internationally.
• Capability to stand or remain stationary for 6-10 hours daily with frequent movement; occasional squatting, kneeling, or bending.
• Light to moderate lifting up to 20-50 pounds including medical equipment.

Additional Information

• Beneficial employment packages including 401k, medical/dental/vision benefits, disability insurance, flexible spending accounts, life insurance.
• Three weeks of paid time off and fourteen paid holidays annually.
• Scrub uniform vouchers provided for certain roles.
• Equal employment opportunity employer adhering to all federal, state, and local non-discrimination laws.