Senior Clinical Research Associate

Sunnyvale, CA

Posted: 10/29/2020 Position Categories: Science

Job Description

The Senior Clinical Research Associate plays a major role in the execution of clinical trials in addition to supporting the design, plan and implementation of such. Works with and may lead a study team regarding all operational activities for new and/or on-going in vitro diagnostic clinical evaluations.

 

ESSENTIAL JOB RESPONSIBILITIES:

  • Independently execute all activities related to a clinical study, including (but not limited to):
  • Clinical site selection
  • Site contract and budget negotiation
  • Study initiation visits
  • Interim monitoring visits
  • Study close out visits
  • Data monitoring activities, including on-site and remote audits of study data for accuracy, integrity, and completeness
  • Identify and suggest ways to resolve problems or issues which could affect the integrity of the data or timely completion of the clinical study.
  • Prepare and/or review study protocols and study documents for new and modified products.
  • Prepare and/or review clinical reports and applicable sections of regulatory submissions and scientific abstracts, posters, and publications.
  • May serve as the clinical affairs representative on a project team.
  • Maintain a high level of familiarity with clinical literature in the field of study and related areas and stay up to date on major advances in disease diagnosis and/or detection and the use of new tests and advances in clinical practice.

Job Requirements

Education and Experience (in years): 

  • Bachelor’s degree in a scientific discipline (Clinical Sciences, Health/Life Sciences, Biology, Biochemistry and/or Human Physiology).
  • Minimum of 5 to 8 years of experience with monitoring In Vitro Diagnostic (IVD) products or medical devices.

Knowledge and skills: 

  • Experience in all aspects of a clinical trial including, but not limited to, clinical site selection, study visits, preparation of study contracts and budgets, and drafting study-specific documents (study protocol, monitoring plan, case report forms, etc.).
  • Knowledge of good clinical trial design and basic understanding of statistics.
  • Remain current on clinical trial regulatory requirements and guidelines (e.g. GCP, ICH, FDA, etc) with the ability to translate current regulatory requirements into clinical trial.
  • Excellent oral and written communication skills. Ability to develop strong rapport with investigators and site staff.

Physical requirements/abilities:

  • Must be able to lift 15 lbs.

Other: Travel

  • Travel requirements of 20-40%

PREFERRED REQUIREMENTS:

  • Experience with in vitro diagnostic (IVD) products in molecular diagnostics or immuno-diagnostics especially in the areas of oncology and/or infectious disease
  • Good understanding of medical terminology, human physiology and laboratory testing
  • Experience with laboratory automation and biological databases
  • Experience with CE and/or US-IVD regulatory submissions
  • CCRA certification

Additional Information

For more than forty years, Richmar Associates has connected talented job seekers with Silicon Valley businesses from start-ups to Fortune 500. We specialize in the temporary and direct placement services business. Based in the Silicon Valley, Richmar offers staffing solutions that include temporary, temp-to-hire, payroll service, vendor management and direct placement services to clients in the High-Tech Industry.

Richmar is an Equal Opportunity Employer.

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