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The University of Texas at Austin · 3 months ago

Clinical Research Associate I

AUSTIN, TX

Full-time

Onsite

Entry Level

1+ years exp

The University of Texas at Austin is seeking a Clinical Research Associate I to assist in the planning, execution, and monitoring of clinical trials. The role involves site management, data collection, and ensuring compliance with regulatory requirements and study protocols.

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Responsibilities

Conduct site initiation, monitoring, and close-out visits while managing participant recruitment, screening, and enrollment to ensure protocol adherence, regulatory compliance, and successful study execution

Ensures compliance with study protocols and regulatory requirements

Manages site performance and resolves issues

Administers questionnaires, collect medical history, and perform study procedures

Maintains rapport with participants to ensure retention and address concerns

Obtains informed consent and ensure participant safety throughout protocol procedures

Coordinates with affiliated departments and external collaborators

Collects and verifies data from clinical sites

Ensures accurate and timely data entry into electronic data capture systems (e.g. REDCap)

Reviews and resolves data queries

Assists with manuscript and grant preparation, including opportunities for authorship

Maintains and updates study databases and data collection forms

Ensures adherence to Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) guidelines

Facilitate institutional review board (IRB) applications, submissions, and updates across multiple sites

Prepares and maintains regulatory documents

Coordinates with ethics committees to safeguard participant rights

Participate in internal and external audits and protocol reviews

Evaluates medical records and performs screenings to identify eligible study participants

Assists in screening and enrolling study participants

Maintains communication with participants to ensure retention

Addresses participant concerns and queries

Prepares study reports and documentation

Maintains accurate records of study activities

Assists in the preparation of manuscripts and publications

Conducts literature reviews to support study design and protocol development

Assists in the training of new site staff and research team members

Participates in internal and external audits

Supports the development of study protocols and case report forms

Attends conferences and workshops to stay updated on industry trends

Adheres to internal controls and reporting structure

Performs related duties as required

Qualification

Clinical research experienceIRB processes familiarityElectronic data captureClinical Practice (GCP)Statistical software experienceHuman Subjects Protection TrainingCommunication skillsAttention to detailOrganizational skillsTeamwork