Clinical Research Associate 2

Hologic•San Diego, CA

About The Position

The Clinical Research Associate 2 independently conducts clinical site monitoring and management activities in accordance with applicable regulations, Good Clinical Practice, departmental procedures, and the Clinical Monitoring Plan. The role serves as the primary clinical site contact on behalf of Hologic, maintains regular communication with site staff, and helps ensure protocol adherence, accurate data collection, complete records, and continued qualification of investigators, staff, facilities, and equipment. The CRA identifies and resolves site issues, documents monitoring activities, and supports audit readiness through appropriate study documentation and regulatory document management. Under moderate supervision, the CRA conducts site qualification, initiation, interim monitoring, and close-out visits; reviews clinical data and site records; assists sites with IRB submissions and documentation; and prepares monitoring visit reports and letters. The role also supports study documents, recruitment and retention efforts, database validation and quality control, and other project tasks as needed. It may include training or mentoring Clinical Trial Assistants and less experienced CRAs. Travel is 30–60%.

Requirements

BA or BS degree.
At least 2 years of related experience.
Intermediate knowledge of clinical trial practices and regulations.
Demonstrated experience in independent clinical trial monitoring and site management.
Proficiency using clinical trial databases and clinical data management systems.
Familiarity with clinical laboratory equipment and instrumentation.
Proficient computer skills, including Microsoft Office.

Nice To Haves

Experience with In Vitro Diagnostic (IVD) clinical studies.

Responsibilities

Conduct site qualification, initiation, interim monitoring, and close-out visits in accordance with regulations, Good Clinical Practice, departmental procedures, and the Clinical Monitoring Plan.
Serve as the primary clinical site contact and establish and maintain regular communication with clinical sites and site staff.
Review site documents, source data, informed consent forms, study materials, and records to ensure compliance, completeness, and accurate clinical data collection.
Use electronic data capture systems and other monitoring tools to review clinical data.
Assist sites with site-level IRB submissions, queries, and documentation.
Prepare monitoring visit reports and letters and document site communications in a timely and accurate manner.
Identify and address routine site issues, including protocol deviations and subject recruitment and retention concerns; communicate study or data trends and proposed resolutions.
Resolve non-routine site issues in conjunction with the Study Lead.
Confirm continued qualification of the principal investigator, study staff, facilities, and equipment.
Facilitate distribution, collection, and tracking of regulatory documents to support site compliance and audit readiness.
Assist with development of clinical trial documents and provide input on study-related documents, including the Clinical Monitoring Plan, informed consent forms, template source documents, study manual, and regulatory binder.
Assist in validation and quality control of clinical study databases and conduct QC reviews of study files and data reports.
Perform additional project tasks as determined by department and organizational needs.
May train and mentor Clinical Trial Assistants and less experienced CRAs.
Travel 30–60%.