Clinical Trials Assistant

POSITION SUMMARY

The Assistant to the Clinical Trials Coordinator will support the execution of clinical research studies conducted in accordance with FDA regulations, GCP guidelines, and sponsor protocols. This role provides administrative, data entry, and organizational support to the Clinical Trials Coordinator to ensure the seamless and compliant conduct of clinical trials. We are a growing visionary clinical trials department leading the way in gene therapy. 

ESSENTIAL FUNCTIONS

Study Preparation & Support

• Assist in reviewing study protocols and related documents to gain familiarity with study objectives, procedures, and timelines.
• Help prepare study materials, regulatory binders, and participant documentation packets.
• Coordinate logistics for investigator meetings, monitor visits, and site audits.
• Support the submission and tracking of IRB documentation, amendments, and study-related correspondence.

Volunteer Coordination

• Support subject recruitment efforts by maintaining screening logs and outreach tracking.
• Schedule and confirm subject visits and assist with appointment preparation.
• Provide subjects with visit instructions and assist in delivering clear, compassionate communication about trial participation.
• Ensure the timely collection and organization of informed consent forms.

Data Entry & Regulatory Compliance

• Assist in entering subject data into sponsor portals and internal databases accurately and timely.
• Upload study procedures to designated reading centers and maintain organized data capture forms.
• Monitor and update temperature logs, IOP logs, calibration records, and other required tracking logs.
• Assist in preparing source documents and case report forms for audits or sponsor reviews.

Sample & Medication Handling

• Ensure appropriate labeling, documentation, and shipping of laboratory samples per protocol.
• Support the Clinical Trials Coordinator in maintaining investigational product accountability and storage logs.

Documentation & Reporting

• Maintain secure and organized electronic and physical trial records.
• Assist with documentation required for adverse event reporting and sponsor notifications.
• Prepare summary updates and support progress reporting to the IRB as needed.

Other Responsibilities

• Stay current on GCP training and assist in tracking certification status for the research team.
• Provide general administrative support, including filing, scanning, and document organization.
• Serve as a liaison for internal communications between clinical staff and research team members.
• Protect participant confidentiality and ensure all sensitive materials are handled per HIPAA and internal policies.

KNOWLEDGE, SKILLS, AND ABILITIES

• Knowledge of commonly accepted administrative support concepts, policies, practices, and procedures.

• Demonstrate a strong attention to detail with the ability to be highly organized- highly focused to complete tasks accurately and timely.

• Proven experience demonstrating superior communication and interpersonal skill (verbal and written) with internal and external stakeholders.

• Effectively solve problems with minimal assistance.

• Proficient with Microsoft Office Suite and the ability to be comfortable learning new software and programs.

• Ability to handle confidential information and exercise discretion.

• Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions and decimals

• Basic knowledge of data entry and ordinary reconciliation.

EDUCATION | EXPERIENCE

• High school graduate or equivalent required

• One (1) year of work experience in a similar role preferred

• Associate or bachelor’s Degree preferred

PHYSICAL DEMANDS AND WORK ENVIRONMENT

The Physical Demands and Work Environment characteristics described below are critical features of this job and are representative of those that must be met by an employee to successfully perform the essential functions. They may be subject to change at any time due to reasonable accommodation or other reasons. After hours may be required.

Reasonable Accommodation Statement: Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions. The nature of those accommodations will be determined on a case-by-case basis.