Clinical Research Associate 2

Hologic•San Diego, CA

2d•$80,700 - $126,100

About The Position

The Clinical Research Associate 2 (CRA 2) independently conducts clinical site monitoring and management visits in accordance with applicable regulations, departmental plans and procedures, and the Clinical Monitoring Plan. The CRA 2 serves as Hologic’s primary contact for clinical sites, trains and communicates regularly with site staff, and ensures protocol adherence, accurate data recording, and continued qualification of investigators, staff, facilities, and equipment. The role identifies and resolves site issues, prepares timely monitoring reports, and manages study documentation. The CRA 2 supports the Study Lead with clinical trial documents, subject recruitment and retention programs, site regulatory-document tracking, and quality-control reviews of study files and data reports. The position may also provide training and mentoring to Clinical Trial Assistants and less experienced CRAs and collaborates with other functional areas to address site issues. Work is performed under moderate supervision, with occasional consultation with a manager or Study Lead.

Requirements

Bachelor of Arts or Bachelor of Science 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 with 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

Conducts Site Qualification, Initiation, Interim Monitoring, and Close-Out visits and activities independently in accordance with FDA regulations, Good Clinical Practice, departmental procedures, and the Clinical Monitoring Plan.
Ensures records are complete and consistent with governing regulations.
Uses electronic data capture systems and other monitoring tools to review clinical data for accuracy and completeness.
Assists sites with site-level IRB submissions, queries, and documentation.
Establishes and maintains regular communication with clinical sites.
Conducts on-site interim monitoring activities, including document review, source data verification, informed consent review, site documentation review, and study-material accountability.
Prepares monitoring visit reports and letters and documents site communications.
Identifies and addresses routine site issues, including protocol deviations and subject recruitment and retention, and communicates study or data trends and proposed resolutions.
Resolves non-routine site issues in conjunction with the Study Lead.
May assist with the development of clinical trial documents.
Ensures distribution, collection, and tracking of regulatory documents to support site compliance and audit readiness.
Assists in validation and quality-control review of clinical study databases.
Reviews the Clinical Monitoring Plan, informed consent forms, template source documents, study manual, regulatory binder, and other study-related documents, providing input as needed.
Performs additional project tasks as determined by department and organizational needs.
May train and mentor Clinical Trial Assistants and less experienced CRAs.
Collaborates with other functional areas to identify site issues and develop ways to resolve them.