Clinical Trial Assistant

Responsibilities

• Study Administration: Assist with day-to-day coordination of clinical research studies, schedule study visits, calls, and participant follow-up activities, prepare study materials and participant packets (informed consents), coordinate shipment and receipt of study supplies, track study enrollment and participant status, maintain study calendars and visit schedules.
• Regulatory Support: May assist with maintaining Investigator Site Files (ISF) and regulatory binders, assist with IRB submissions, amendments, continuing reviews, and reportable events, organize essential documents according to GCP guidelines, track regulatory approvals and expiration dates, ensure study documentation is complete and audit-ready.
• Data Management: Assist with entry of study data into electronic data capture (EDC) systems, review source documentation for completeness, assist with query resolution, maintain study tracking logs and screening logs, ensure timely and accurate documentation.
• Participant Support: Assist with participant recruitment activities, conduct reminder phone calls, emails, and appointment confirmations, prepare informed consent documents for coordinator review, collect questionnaires and study forms, maintain participant confidentiality in accordance with HIPAA regulations.
• Laboratory and Specimen Support: Prepare specimen collection kits, coordinate specimen shipping, maintain specimen inventory logs, track laboratory supplies.
• Administrative: Maintain study correspondence, assist with sponsor monitoring visits and audits, coordinate document requests, comply with Good Clinical Practice (ICH-GCP) guidelines, maintain HIPAA compliance, adhere to institutional SOPs, protect participant confidentiality, complete required research training, support quality assurance initiatives, assist during internal and external audits.

Qualifications

• Possess 0-2 years of clinical research experience in a healthcare, laboratory, or administrative setting.
• Demonstrate a basic understanding of clinical research processes, Good Clinical Practices (GCPs), HIPAA regulations, IRB requirements, and the informed consent process.
• Exemplify hands-on experience with Google Workspace, Adobe Acrobat, Database management, and file organization.
• Knowledge of Electronic Medical Records (EMR) and Electronic Data Capture (EDC) systems.
• Exemplify the ability to multitask and thrive in an agile, fast-paced, deadline-driven environment while remaining flexible, proactive, resourceful, and efficient.
• Possess proficient verbal and written communication skills, while willing to share and receive information and ideas from all levels of the organization to achieve the desired results.
• Possess high ethics and conduct business in the most professional manner.
• Solicit inclusiveness and collaboration but step up to responsibility, make tough decisions, and be accountable for those decisions.
• Act as a results-oriented team player with strong interpersonal and communication skills, capable of working collaboratively with colleagues.