Clinical Trial Assistant

JOB SUMMARY

Responsible for the collection, coordination, processing and quality control of clinical trial data. May assist with screening patients for research protocols. Maintains research protocol information, regulatory documents and other research files as applicable. Works in compliance with USA Clinical Trials (USACT) Standard Operating Procedure (SOP), principles of Good Clinical Practice and all applicable federal, state, and local regulations

. Responsibilities:

· Assist the Research Coordinate in the coordination of studies according to ICH and GCP guidelines as specified in the protocol.

· Assists in the daily clinical trial activities and plays a critical role in the conduct of the study.

· Assists in the Scheduling of study participant appointments and serves as the patient liaison to the PI and other participating physicians.

· Reviews and comprehends each assigned protocol including study proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protections.

· Completes case report forms. Extracts data from patient charts in a timely manner

· Responds to data clarification requests in a timely manner.

· Coordinates with PIs to help ensure that clinical research and related activities are performed in accordance with Federal regulations, ICR and sponsoring agency policies and procedures.

· Completes documentation on each study visit that is used to track all study related activities so that time, effort and materials can be accounted for monthly.

· Works collaboratively with the other members of the clinical research team and the clinical and administrative support teams to ensure all protocols are followed and that there is timely documentation and submission of study data.

· Assists with study materials including but not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs.

· Establishes and organizes study files, including but not limited to, study specific source documentation and other materials as required.

· Arranges secure storage of study documents that will be maintained according to USACT institutional policy or for the contracted length of time, whichever is longer.

· Promotes the ethical conduct of research by reporting good faith suspicions of misconduct in research to the Director of Research.

· May perform other job-related duties as requested or required

· Maintains professional, respectful, and compassionate communication with patients and team members.

· Adheres to departmental policies, including dress code and confidentiality standards.

· Provides staff coverage as needed and performs other duties as assigned.

· Must wear the appropriate uniform while on duty.

· Follows all organizational protocols, policies, and procedures.

· Completes tasks efficiently, accurately, and on time.

· Follows policy regarding attendance, punctuality, and meal breaks. Understands that late arrivals, early departures, and unapproved absences can disrupt workflow and patient care.

· Maintains a courteous and professional demeanor when interacting with patients, staff, and external contacts.

· Keeps work areas clean, organized, and free from clutter.

· Reports to work as scheduled, ready to begin duties on time, and remains present for the entire scheduled shift unless otherwise approved.

REQUIRED SKILLS

· Ability to work with other research team members and have strong organizational and time management skills

· Strong critical thinking and problem-solving skills

· Ability to work under pressure

· Dependable

· Exercises safe judgment in decision making

· Demonstrates tact and understanding when dealing with patients, team members, members of other disciplines, and the public

· Must possess honesty, integrity, and accountability

· Excellent interpersonal skills to deal effectively with clinicians, patients, administrators, auxiliary personnel, regulators, monitors and sponsors.

· Excellent organizational skills to independently manage work flow.

· Ability to prioritize quickly and appropriately.

· Ability to multi-task

DUTIES AND ESSENTIAL JOB FUNCTIONS

· Follow protocol-specific requirements to successfully carry out the study

· Code, evaluate, or interpret collected study data.

· Document and maintain required records necessary for study activities per local, state, and FDA GCP requirements.

· Maintain professional communication with investigators, sponsors, and study personnel.

· Must be flexible and adaptable to a changing environment with our growing research department

Other functions and Responsibilities

This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

COMPETENCIES

1. Patient & Customer Focus

2. Ethical Conduct

3. Flexibility

4. Initiative

5. Personal Effectiveness/Credibility

6. Stress Management/Composure

QUALIFICATIONS

Required

· High attention to detail and strong organizational skills

· Excellent written and verbal communication skills

· Ability to work well independently

· Maintain confidentiality

· Experience with Microsoft Office Suite (Outlook, Word, Excel, PowerPoint)

· Possess strong skills for multitasking, meeting competing deadlines, prioritizing and supporting PIs for multiple projects

QUALIFICATIONS

· Prior office experience

· Prior Research-related experience preferred but not required (with human participants preferred)

· Prior experience in a similar-sized facility and comparable services provided preferred but not required.

REQUIRED LICENSES/CERTIFICATIONS

Required

· High school diploma or general education degree required