Clinical Research Associate I Full-time

Clinical Research Associate I

Dell Medical School is seeking a Clinical Research Associate I. This is a grant funded position with an end date of August 31, 2027.

The Clinical Research Associate I (CRA I) will conduct interviews and support research project management for two different mental health studies. One study is focused on the impact of a traumatic event on a child's mental health, and the other study is focused on the cognitive impact of early psychosis on adolescents and young adults who are within two years of their psychotic disorder diagnosis. Key responsibilities include site management, data collection, and ensuring the integrity of clinical data.

Responsibilities:

• Site Management
• Ensures compliance with study protocols and regulatory requirements.
• Manages site performance and resolves issues.
• Data Collection and Management
• Conducts participant interviews.
• Ensures accurate and timely data entry into electronic data capture systems.
• Reviews and resolves data queries.
• Regulatory Compliance
• Ensures adherence to Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) guidelines.
• Facilitates institutional review board (IRB) applications, submissions, and updates across multiple sites.
• Prepares and maintains regulatory documents.
• Coordinates with ethics committees to safeguard participant rights.
• Participant Recruitment and Retention
• Coordinates with clinical partners to identify eligible study participants.
• Assists in screening, enrolling, and consenting of study participants.
• Maintains communication with participants to ensure retention.
• Addresses participant concerns and queries.
• Reporting and Documentation
• Prepares study reports and documentation.
• Maintains accurate records of study activities.
• Assists in the preparation of manuscripts and publications.
• Marginal or Periodic Functions
• 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.

Knowledge/Skills/Abilities

• Double-checks work for errors, maintains organized records, and follows detailed procedures.

• Writes clear and concise reports, actively listens to others, and presents information effectively.

• Analyzes information, develops solutions, and implements corrective actions.

• Shares information, supports team decisions, and contributes to team success.

• Prioritizes tasks, sets realistic deadlines, and uses time efficiently.

Required Qualifications

Requires a Bachelor's Degree in psychology, social work, public health, or a related field with at least 1 year(s) of experience in clinical research. Relevant education and experience may be substituted as appropriate.

Preferred Qualifications

Master's Degree in psychology, social work, public health, or a related field with at least 2 year(s) of clinical research experience. Experience working with children, adolescents, and young people who have a mental health condition. Fluent in Spanish. Certified Clinical Research Associate (CCRA) or Certified Clinical Research Professional (CCRP).

Salary Range

$40,000 + depending on qualifications

Working Conditions

• Standard office equipment

• Repetitive use of a keyboard

• Use of manual dexterity.

• Occasional weekends, overtime, and evening work to meet deadlines

Required Materials

• Resume/CV
• 3 work references with their contact information; at least one reference should be from a supervisor
• Letter of interest