Clinical Research Associate 1

Hologic•San Diego, CA

About The Position

The Clinical Research Associate 1 (CRA 1) conducts clinical site monitoring and management activities in accordance with applicable regulations, departmental plans and procedures, and the Clinical Monitoring Plan. Monitoring may be performed in-house or through site visits, independently or alongside more experienced personnel. The CRA 1 may act as a primary or secondary clinical site contact on behalf of Hologic, trains and communicates regularly with site staff, and works under frequent supervision and guidance, consulting the manager or Study Lead regularly. The role ensures protocol adherence and accurate, complete study data and records; verifies the continued qualification of investigators, study staff, facilities, and equipment; and identifies and resolves routine site issues. Responsibilities include conducting site qualification, initiation, interim monitoring, and close-out activities; reviewing source data, informed consent forms, site documentation, study materials, and regulatory files; preparing monitoring reports and correspondence; supporting site-level IRB submissions; and facilitating regulatory-document tracking and audit readiness. The CRA 1 also performs quality-control reviews of study files and data reports, may assist with database validation and clinical-trial document development, and may train or mentor Clinical Trial Assistants. The position requires a BA or BS degree and 1–2 years of related experience. Experience with In Vitro Diagnostic (IVD) clinical studies is a plus. The role includes travel of 30–60% and physical activities that include sitting, standing, walking, reaching, stooping, kneeling, crouching, or crawling; lifting, moving, or carrying items weighing up to 40 pounds; and exposure to moving mechanical parts, vibration, moderate noise, hazardous chemicals or other materials, and blood. The annualized base salary range is $73,500–$101,500, and the position is eligible for an annual bonus.

Requirements

BA or BS 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.
Ability to travel 30–60%.
Ability to perform the listed physical activities and work in the described exposure conditions, including lifting or carrying up to 40 pounds.

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 regulations, Good Clinical Practice, departmental procedures, and the Clinical Monitoring Plan.
Ensure study records are complete and consistent with governing regulations, and ensure protocol adherence 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.
Establish and maintain regular communication with clinical sites and serve as a primary or secondary site contact as needed.
Conduct interim site monitoring, including document review, source data verification, informed-consent review, site-document review, and study-material accountability, independently or as a co-monitor.
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 matters; communicate study or data trends and proposed resolutions.
Resolve non-routine site issues in conjunction with the Study Lead.
Distribute, collect, and track regulatory documents to support site compliance and audit readiness.
Conduct quality-control reviews of study files and data reports and 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.
May assist with development of clinical-trial documents.
May train and mentor Clinical Trial Assistants.
Perform additional project tasks as determined by department and organizational needs.