Clinical Research Associate 1

Hologic•San Diego, CA

3d•$73,500 - $101,500

About The Position

The Clinical Research Associate 1 (CRA 1) conducts clinical site monitoring and management activities in accordance with regulations, departmental plans and procedures, and the Clinical Monitoring Plan. Monitoring may be conducted in-house or at sites, independently or alongside more experienced personnel. The CRA 1 may act as a primary or secondary site contact for Hologic, trains and communicates regularly with site staff, and helps ensure protocol adherence and accurate data recording. The role confirms that principal investigators, study staff, facilities, and equipment remain qualified; identifies and resolves routine site issues; prepares timely monitoring reports; manages study documentation; and supports regulatory-document tracking, audit readiness, quality control, and data review. The CRA 1 may also train and mentor Clinical Trial Assistants. Under frequent supervision and guidance, the CRA 1 performs varied work that may be somewhat difficult. More experienced personnel may support or oversee essential duties. The role conducts site qualification, initiation, interim monitoring, and close-out activities; supports site-level IRB submissions; reviews study documents and clinical data; assists with database validation and QC; and addresses site issues in coordination with the Study Lead when they are non-routine. Travel is 30–60%.

Requirements

Bachelor of Arts or Bachelor of Science degree.
1–2 years of related experience.
Working knowledge of clinical trial practices and regulations.
Working knowledge of clinical trial monitoring and site management.
Basic knowledge of clinical trial databases and clinical data management systems.
Some familiarity with clinical laboratory equipment and instrumentation.
Intermediate 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 and activities in accordance with applicable FDA regulations, Good Clinical Practice, guidelines, departmental procedures, and the Clinical Monitoring Plan.
Ensure study records are complete and consistent with governing regulations.
Use electronic data capture systems and other monitoring tools to review and ensure accurate, complete clinical data collection.
Assist sites with site-level IRB submissions, queries, and documentation.
Establish and maintain regular communication with clinical sites.
Conduct on-site interim monitoring, including document review, source data verification, review of informed consent forms and other site documentation, and study-material accountability, independently or as a co-monitor.
Prepare monitoring visit reports and letters and document site communications, independently or with oversight.
Identify and address routine site issues, including protocol deviations and subject recruitment and retention, and communicate study or data trends and proposed resolutions.
Resolve non-routine site issues in conjunction with the Study Lead.
Assist with development of clinical trial documents.
Distribute, collect, and track regulatory documents to support site compliance and audit readiness.
Assist with validation and quality control of clinical study databases.
Review the Clinical Monitoring Plan, informed consent forms, template source documents, study manual, regulatory binder, and other study-related documents, providing input as needed.
Perform additional project tasks based on department and organizational needs.
Work under frequent supervision and confer regularly with the manager or Study Lead.