Clinical Trial Assistant

Geneoscopy, Inc.•Maryland Heights, MO

13d•Onsite

About The Position

The Clinical Trial Assistant (CTA) provides administrative and operational support for clinical research studies conducted in accordance with federal regulations, Good Clinical Practice (GCP), institutional policies, and study protocols. The CTA assists research coordinators, project managers, investigators, sponsors, and study participants by maintaining regulatory documentation, coordinating study activities, tracking study milestones, and ensuring accurate data and records management. This position serves as an integral member of the clinical research team and contributes to the successful execution of clinical trials while maintaining participant confidentiality and regulatory compliance.

Requirements

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.
Seek 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.

Nice To Haves

CITI Human Subjects Protection training
GCP certification
Supporting FDA-regulated clinical trials
Reading medical records/pathology reports
Clinical trial documentation
Collaborating with sponsors or Vendors

Responsibilities

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
May assist with maintaining Investigator Site Files (ISF) and regulatory binders.
May 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
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
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
Prepare specimen collection kits
Coordinate specimen shipping
Maintain specimen inventory logs
Track laboratory supplies
Maintain study correspondence
Assist with sponsor monitoring visits and audits
Coordinate document requests
Follow 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.
Other duties as assigned.