Clinical Research Associate I

About the role

The Clinical Research Associate I (CRA I) supports foundational operational aspects of clinical trials, ensuring compliance with Good Clinical Practices (GCP) and Human Subjects Protection regulations.

Responsibilities

• Supports site monitoring activities, including preparation for qualification, initiation, monitoring, and close-out visits.
• Participates in remote and on-site visits in a shadowing or support capacity.
• Conducts supervised source data review (SDR) and basic source data verification (SDV).
• Drafts or updates visit documentation for senior review.
• Aids in participant safety and compliance verification, including reviewing AE/SAE listings and confirming eligibility criteria alignment.
• Supports essential document management, such as collecting, uploading, organizing, and tracking essential regulatory documents.
• Prepares document packets for monitoring visits and audits.
• Maintains study trackers, systems, and communication, including updating CTMS, EDC task lists, issue logs, and monitoring visit calendars.
• Communicates site needs, questions, and status updates in a timely manner.
• Supports investigative product (IP) documentation, including preparing IP accountability forms and checklists for monitoring visits.
• Assists in audit and inspection readiness, such as document retrieval and basic pre-audit file checks.

Requirements

• Minimum Qualifications: Requires a Bachelor's Degree in life sciences, nursing, public health or a related field; basic understanding of GCP/Human Subjects Protection; relevant education and experience may substitute.
• PREFERRED QUALIFICATIONS: Bachelor's Degree in life sciences, nursing, public health or a related field with at least 1 year of experience in clinical research support.

Qualifications

• Basic understanding of GCP/Human Subjects Protection.
• Ability to follow SOPs, maintain accuracy, and learn quickly.
• Relevant education and experience may substitute as appropriate.

Skills

• Attention to detail.
• Learning agility.
• Planning and organizing.
• Problem solving.
• Interpersonal savvy.
• Written communication.

Benefits

N/A

Pay

$40,000 + depending on qualifications

Schedule

Standard office equipment; repetitive use of a keyboard.