Urology San Antonio ยท 4 months ago
Clinical Trial Assistant
Urology San Antonio is a healthcare provider focused on clinical trials. They are seeking a Clinical Trial Assistant responsible for collecting, coordinating, and processing clinical trial data, while ensuring compliance with regulatory standards and assisting with patient interactions.
Health CareHealth Diagnostics
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
Qualification
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
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
High school diploma or general education degree required
Preferred
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