Clinical Research Associate 3

We are hiring in our Diagnostics division here in San Diego! The Clinical Affairs department is looking for a Clinical Research Associate 3, responsible for independently conducting site monitoring/management visits in accordance with regulations and department plans, as well as procedures.

This is a hybrid role with 3 days onsite per week. CRAs are also required to travel up to 30 - 60% of the time, and mainly within the US.

Job Summary

• The Clinical Research Associate 3 (CRA 3) 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.
• Assists 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 
• Assists Clinical Operations Manager in training of CRAs
• May serve as clinical operations lead on clinical research studies
• May supervise lower level CRAs and Clinical Trial Assistants

Required Education and Qualifications 

• BA or BS degree specific to Scientific fields
•  5-8 years of related experience. Experience with In Vitro Diagnostic (IVD) clinical studies a plus.

Skills

• Advanced knowledge of clinical trial practices and regulations
• Advanced knowledge of independent clinical trial monitoring, management, and trial design
• Advanced use of clinical trial databases and clinical data management systems
• Familiarity with clinical laboratory equipment and instrumentation
• Proficient computer skills including Microsoft Office
• Must follow all applicable FDA regulations and ISO requirements.

Be part of a team that’s redefining the future of healthcare, one data point at a time. Join Hologic and help us deliver on our mission to enable healthier lives everywhere, every day.

The annualized base salary range for this role is $97,400 to $152,300 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs, and market demand.

Why Hologic?

We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

If you have the right skills and experience, apply today!

#LI-RF1 #Mid-level

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.