Current Openings

Sr. Regulatory Operations Specialist

PRIMARY OBJECTIVE OF THE POSITION:

The primary duties of this position are to compile, publish and submit eCTD compliant regulatory dossiers to the FDA and other health authorities in a timely manner, and provide Regulatory support to project teams.

QUALIFICATIONS:

The candidate should have a BS degree preferably in a scientific discipline (or equivalent knowledge and experience) and a minimum of 3 years’ experience in Regulatory Operations/electronic submissions. Technical knowledge in eCTD compliant submissions and experience with off-the-shelf publishing software is highly desirable.

Good understanding of FDA’s submission requirements and drug/biologic/device development processes is required. Good oral and written communication skills, detail-oriented, self-directing, and ability to handle multiple projects across all functional areas independently are essential.


Biostatistician

PRIMARY OBJECTIVE OF THE POSITION:

The primary objective of the Biostatistician is to provide statistical expertise in the design and analysis of clinical studies, as well as the interpretation and reporting of the results.

EDUCATION AND EXPERIENCE:

The candidate should have a masters or doctoral level degree in statistics with at least 3 years of experience performing statistical analysis and reporting for clinical trials.

QUALIFICATIONS:

A thorough understanding of the requirements of the management and analysis of clinical data as required by GCPs, FDA and ICH guidelines is essential.  Excellent problem solving, organizational, written and oral communication skills, the ability to manage multiple priorities and attention to detail is critical.   Computer proficiency and SAS programming skills are required.  Understanding of SDTM and ADaM standards.  Ability to perform statistical analyses of clinical data, prepare written interpretations of statistical results and to integrate these findings into clinical study reports and publications.


Regional Sr. Clinical Research Associate (Sr. CRA)

We are looking for a Senior CRA who would be home based in any major metropolitan area close to an airport hub. Our home office is located in San Diego, CA.

PRIMARY OBJECTIVE OF THE POSITION:

The primary objective of the Regional Senior Clinical Research Associate is to be responsible for the independent implementation and management of specific clinical trials. This individual will also have responsibilities for management and monitoring of specific investigative sites.

QUALIFICATIONS:
The ideal candidate will have:

  • A Bachelor’s degree in a scientific discipline, RN or BSN degree, 4-year Life Science degree or equivalent and at least 5 years’ experience in clinical research or the medical field or a combination of education and experience.
  • A knowledge/understanding of the principles of clinical research and drug development.
  • Excellent written and oral communication skills.
  • The ability to manage multiple priorities and attention to detail is critical.

 

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