Clinical Trial Assistant

Clinical Trial Assistant

This is an on-site, in-office position at Geneoscopy HQ in St. Louis, Missouri.

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.

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: 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.
• Compliance: 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.

Education Requirements

• Bachelor's degree in Biology, Health Sciences, Public Health, Nursing, Psychology, or a related field is preferred. Associate's degree with relevant work experience may be considered.

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.
• 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.
• Preferred Additional Experience: 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.

Schedule: This is a salaried position, requiring at least 40 hours per week. There may be projects that require activities beyond the standard hours.

Compensation & Benefits

• Base salary range: annually determined based on the candidate's experience, knowledge, and abilities.
• Bonus: discretionary annual bonus based on a percentage of the employee's base salary
• Benefits: health, vision, dental, life insurance, 401k (with employer match), and paid time off.
• Company stock options

Additional Information

Geneoscopy's Core Values Ability to embody Geneoscopy's beliefs, philosophies, and principles:

• Integrity - we do the right thing through our words, actions, and behaviors
• Courage - step up, speak up, stand out
• Agility - think and act fast, embracing change
• Passion - for our customers, our people, our work, and for excellence
• Collaboration - our differences are assets

Physical Demands

• Employees may be required to lift routine office supplies and use standard office equipment.
• Must possess the ability to sit and/or stand for long periods.
• Must possess the ability to perform repetitive motion.

Work Environment

• May have exposure to fumes and biohazardous material in the laboratory environment.
• May be required to handle blood-borne pathogens and general laboratory reagents.