Senior Clinical Research Associate
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.
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.
- Must be able to lift 15 lbs.
- Travel requirements of 20-40%
- 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
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.