Hologic Clinical Research Associate in San Diego, California
Clinical Research Associate
Post Date Apr 02, 2018
At Hologic, we’re an innovative medical technology company that enables healthier lives everywhere, every day. We are also a company that prospers and grows, which is why we’ve been able to expand our offerings to empower even more people and champion women’s health
What powers our growth across Breast & Skeletal Health, Diagnostics, GYN Surgical and Medical Aesthetics Solutions is also what differentiates us: the exceptional and clinically proven capacity of our products to detect, diagnose and treat illnesses and other health conditions earlier and better. This clinical superiority creates high expectations, which we fulfill by continually challenging ourselves to improve health through better technology, education and market access.
None of this would be possible without the talent and passion of our employees. Together, our expertise and dedication to developing and sharing more robust, science-based certainty drives our global presence and a promising pipeline that responds to the unmet health and wellness needs of women, families and communities.
While we focus on women’s health and well-being, we are committed to having an even broader benefit on the world. Together, we advocate for better health and wellness through solutions that provide ever greater certainty and peace of mind.
The Clinical Research Associate independently conducts site monitoring/management visits in accordance with regulations and department plans and procedures. Serves as primary clinical site contact on behalf of Hologic. Trains and maintains regular communication with site staff. Ensures adherence to protocol and accurate data recording. Confirms continued qualification of principal investigator, study staff, facilities and equipment. Identifies and resolves site issues. Writes timely monitoring visit reports and correctly manages study documentation.
The Clinical Research Associate assists the Study Lead with the development of clinical trial documents. Facilitates distribution, collection and tracking of regulatory documents for site compliance and audit readiness. Assist Study Lead with subject recruitment and retention programs. Conducts quality control (QC) review of study files, data reports, tables, and listings. May provide training and mentoring of Clinical Trial Assistants and less experienced CRAs. Interacts with other functional areas to identify site issues and create mechanisms for solving problems as needed.
Essential Duties and Responsibilities
Under moderate supervision and guidance, performs work that is varied and that may be somewhat difficult in character.
Conducts Site Qualification, Initiation, Interim Monitoring, Close-Out visits and activities independently and in accordance with FDA Code of Federal Regulations, Good Clinical Practice, guidelines, departmental procedures and the Clinical Monitoring Plan (CMP)
Ensures records are complete and consistent with governing regulations
Able to use or uses electronic data capture system and other monitoring tools to review and ensure accurate and complete clinical data collection
Assists sites with site-level IRB submissions, queries and documentation
Establishes and maintains regular communication with clinical sites
Conducts on-site interim site monitoring activities independently including document review, source data verification, informed consent forms, other site documentation and study material accountability
Prepares and completes monitoring visit reports and letters and effectively documents site communications
Identifies and addresses routine site issues including protocol deviations, subject recruitment and retention programs and communicates any observed study /data trends and proposed resolution
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 ensure site compliance and audit readiness
Assists in the validation and QC of clinical study database(s)
Reviews 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
Works with moderate supervision, conferring with manager or Study Lead occasionally
- BA or BS degree
- 2+ years or related experience. Experience with In Vitro Diagnostic (IVD) clinical studies a plus.
Intermediate knowledge of clinical trial practices and regulations
Demonstrated experience in independent clinical trial monitoring and site management
Proficient use of clinical trial databases and clinical data management systems
Familiarity with clinical laboratory equipment and instrumentation
Proficient computer skills including Microsoft Office
Agency and Third Party Recruiter Notice:
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.