Clinical Research Associate

Spyglass Pharma•Aliso Viejo, CA

10h•Remote

About The Position

The Clinical Research Associate (CRA) will join our Clinical Operations team in a hands-on role supporting the planning, execution, and monitoring of clinical trials. We are hiring across a range of experience levels, and the title and scope of responsibilities may be adjusted based on background and expertise. This role is integral to the successful execution of our clinical trials, serving as a primary point of contact for clinical sites and supporting patient-centered study conduct. The CRA will conduct monitoring visits, build strong relationships with investigators and site staff, and help ensure studies are executed with quality, consistency, and regulatory compliance across all phases of the trial. This is a U.S. based, remote position that requires regular travel to clinical trial sites across the country (up to 70%). Applicants must be currently authorized to work in the United States and comfortable with a travel-based schedule.

Requirements

Bachelor's degree in life sciences, nursing, or a related field.
Minimum of 4 years of experience in clinical affairs within the pharmaceutical or medical device industry, with a preference on drug and drug/device combination products.
Knowledge of GCP, FDA/ICH guidelines, and clinical trial monitoring practices.
Strong organizational and problem-solving skills.
Excellent communication and interpersonal skills, with the ability to build strong relationships with investigative sites and internal teams.
Proficiency in Microsoft Office and electronic data capture (EDC) systems.
Ability to travel up to 50-75% domestically, as required.
Currently authorized to work in the United States.

Responsibilities

Conduct site monitoring visits (initiation, routine, and close-out) to ensure compliance with the clinical protocol, GCP, and regulatory requirements.
Assist in the preparation and review of essential trial documents, such as informed consent forms, case report forms, and investigator brochures.
Collaborate with site staff to ensure proper documentation, timely data entry, and resolution of data queries.
Assist in the identification, selection, and training of investigative sites.
Maintain accurate and complete study files and records in accordance with GCP and company SOPs.
Monitor study progress to ensure timelines and quality standards are met.
Report site activities and findings to the Clinical Study Manager and escalate issues as necessary.
Support regulatory submissions by preparing clinical trial applications and maintaining relevant documentation.
Work collaboratively with cross-functional teams, including Regulatory Affairs, Quality Assurance, and Project Management, to achieve study objectives.