Clinical Research Associate I

The University of Texas at Austin•Austin, TX

2d•Onsite

About The Position

The Clinical Research Associate I (CRA I) is responsible for assisting in the planning, execution, and monitoring of clinical trials to ensure compliance with regulatory requirements and study protocols. Key responsibilities include site management, data collection, and ensuring the integrity of clinical data. The Clinical Research Associate I will perform independently or with general direction at the fully operational journey level of the series to execute, manage, and coordinate research protocols, as directed by the Principal Investigator (PI). This role may coordinate the data collection and operations of multiple concurrent clinical research studies under the guidelines of research protocols, The University of Texas at Austin, and regulatory agency policies. A successful candidate will possess strong attention to detail; excellent interpersonal, verbal, and written communication skills; the ability to coordinate with subjects, team members, other departments, and external institutions; the ability to multitask in a fast-paced environment while working with a diverse subject population; and the ability to prioritize and complete multiple projects within established deadlines.

Requirements

Bachelor’s degree in life sciences, nursing, or a related field
One year of relevant clinical research experience
Familiarity with IRB processes and human subjects protection standards
Experience with electronic data capture systems (e.g., REDCap)
Relevant education and experience may be substituted as appropriate.

Nice To Haves

Master’s degree in life sciences, nursing, or a related field with at least two years of clinical research experience, preferably involving pediatric or neurodevelopmental populations
Experience with statistical software (e.g., R, SAS, SPSS)
Experience presenting research findings or contributing to publications
Completion of Human Subjects Protection Training
Experience working with children and families affected by neurodevelopmental disorders
Strong written and verbal communication skills
Ability to abstract data from medical records and manage complex databases
Certified Clinical Research Associate (CCRA) or Certified Clinical Research Professional (CCRP)

Responsibilities

Site Management & Study Execution 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.
Ensure compliance with study protocols and regulatory requirements.
Manage site performance and resolve issues.
Administer questionnaires, collect medical history, and perform study procedures.
Maintain rapport with participants to support retention and address concerns.
Obtain informed consent and ensure participant safety throughout protocol procedures.
Coordinate with affiliated departments and external collaborators.
Data Collection & Management Collect and verify data from clinical sites.
Ensure accurate and timely data entry into electronic data capture systems (e.g., REDCap).
Review and resolve data queries.
Assist with manuscript and grant preparation, including opportunities for authorship.
Maintain and update study databases and data collection forms.
Regulatory Compliance & Oversight Ensure 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.
Prepare and maintain regulatory documents.
Coordinate with ethics committees to safeguard participant rights.
Participate in internal and external audits and protocol reviews.
Participant Recruitment & Retention Evaluate medical records and perform screenings to identify eligible study participants.
Assist in screening and enrolling study participants.
Maintain communication with participants to support retention.
Address participant concerns and inquiries.
Reporting & Documentation Prepare study reports and documentation.
Maintain accurate records of study activities.
Assist in the preparation of manuscripts and publications.
Marginal or Periodic Functions Conduct literature reviews to support study design and protocol development.
Assist in training new site staff and research team members.
Participate in internal and external audits.
Support development of study protocols and case report forms.
Attend conferences and workshops to stay updated on industry trends.
Adhere to internal controls and reporting structure.
Perform related duties as required.