Clinical Research Scientist

Organization
Hologic - San Diego
Job Location
San Diego, CA 92121
Job Description

Hologic is seeking a Clinical Research Scientist responsible for scientific support of new or on-going clinical trials.

 

Duties & Responsibilities:

  • Responsible for design of  clinical studies with the appropriate hypotheses and methods to ensure scientific integrity in accordance with current regulations and guidelines.
  • Work with the medical writing team to develop background and discussion language for regulatory documents, including researching and writing.
  • Critically review regulatory documents including clinical plans, pre-submission documents, clinical study protocols and reports, integrated summaries, labeling, responses to FDA and other regulatory agency.
  • Work with team members to ensure scientific integrity of data by assisting in the development of data collection/review/analysis materials (e.g., CRFs, statistical analysis plans).
  • Provide scientific guidance to team members while study is active and review data to identify and investigate discrepant results or issues.
  • Assist in training project staff.
Requirements

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the basic knowledge, skills, and/or abilities required:

  • Working knowledge of statistics to apply and understand appropriate study design and data analysis for clinical trials.
  • Familiarity with different clinical study designs for IVD devices.
  • Familiarity with FDA regulations related to clinical trials for IVD devices.

Education:

  • BA or BS degree

Experience:

  • 8-10 years of related experience.

Additional Details:

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

How to Apply
About Our Organization

Hologic, Inc. is a leading developer, manufacturer and supplier of premium molecular diagnostic products and services that are used to diagnose human diseases, screen donated human blood and to aid in biomedical research. Hologic is also a leader in the development, manufacturing and sales of medical imaging systems and biopsy devices as well as surgical and treatment products, with an emphasis on serving the healthcare needs of women. Our business is dedicated to impacting the lives of people across the globe through the early detection of disease, improved diagnosis and less invasive treatments.

 

There has never been a more exciting time to join us. Bright people, working together to pioneer advances in human health care, have created Hologic's success. Our company believes that people are our greatest asset and only by recruiting, hiring, developing and retaining the most talented employees can we continue to be successful.  Our work atmosphere is stimulating, innovative and customer focused. We provide employees with state-of-the art tools and technology, a collaborative and passionate work environment and the ability to make a dramatic difference in the world of healthcare.

 

We are rapidly growing and yet we have never been more focused – on our people, on our growth, on our future.

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