Hologic Senior Clinical Research Associate in San Diego, California

Senior Clinical Research Associate

Post Date Apr 02, 2018

The Sr. Clinical Research Associate (CRA) 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. Writes timely monitoring visit reports and correctly manages study documentation.

The Sr. CRA may work on multiple projects. Proactively identifies and resolves site issues, in conjunction with the Study Lead. Provides feedback on study/protocol design as requested. Develops clinical trial documents as requested by the Study Lead (e.g., informed consent forms, source document templates). Demonstrates extensive understanding of Hologic technology and products and understanding of investigational product accountability.

Essential Duties and Responsibilities

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

  • Conducts Site Qualification, Initiation, Interim Monitoring, Close-Out visits and activities 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 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 CMP, informed consent forms, template source documents, study manual, regulatory binder and other study-related documents; providing input as needed

  • Works with minimum supervision, conferring with manager or Study Lead on unusual matters.

Education

  • BA or BS degree

Experience

  • 5+ years or related experience. Experience with In Vitro Diagnostic (IVD) clinical studies a plus.

Skills

  • Advanced knowledge of clinical trial practices and regulations

  • Advanced knowledge of clinical trial monitoring, management and trial design

  • Advanced knowledge 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 & VEVRAA Federal Contractor