Clinical Research Associate II

Job Description

Job Description Job ID: CEP004830
About Us
At Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. With our GeneXpert® System, we’ve taken the most sophisticated molecular technology and packaged it into an automated, easy-to-use format that has quickly become the platform of choice worldwide. From the largest laboratories to small physician offices, our game-changing solution delivers critical answers when clinicians and patients need them most. Through strong molecular biology capabilities and ongoing product innovation, we are focused on developing tests for healthcare-associated infections, sexual health, critical infectious disease, virology, and oncology applications. Come join our vision for a better way and help make life better for us all! For more details, visit us at [ Link Removed ] or follow us on Twitter (@CepheidNews).
Description

• POSITION SUMMARY:
  The Clinical Research Associate at Cepheid is primarily responsible for carrying out the responsibilities involved in the execution of IVD clinical trials. This includes site initiation, monitoring and close out of clinical trial sites. Clinical trials may be carried out at various stages or phases in the life cycle of the product including alpha (early stage feasibility), beta and most importantly the clinical studies that validate the product.
  ESSENTIAL JOB RESPONSIBILITIES:
  • Perform internal performance testing such as proficiency and system testing
  • Prepare study protocols investigator manuals, site specific instruction manuals and design case report forms for new and modified products
  • Identify potential investigators, prepare site budgets and contract agreements
  • Collect, review and process regulatory documents and correspondence from participating trial sites
  • Review on-site files, product accountability logs, study supplies inventory, case report forms, and source documents for completeness, accuracy, consistency and compliance; identifies deficiencies and discrepancies and provides remedial training and/or corrective action as required.
  • Develop and implement study specific tracking tools to aid in monitoring, regulatory document review, and follow up of issue resolution
  • Provide site support for remote/electronic data capture (EDC), review for completeness and consistency, and generate and resolve queries in between monitoring visits
  • Responsible for timely identification of problems or issues that could affect the results or timely completion of the trial, or any protocol deviations, and for suggesting mechanisms for solving the problem
  • Completion of monitoring reports and follow-up letters, which includes providing summaries of significant findings, deviations, deficiencies and recommended action to secure compliance
  • Ensure that studies adhere to FDA regulations, Good Clinical Practices, and IVD directives
  TRAINING RESPONSIBILITIES: (REQUIRED)
  • Complete all assigned and required training satisfactorily and on time
  • For people managers, ensure your associates attend and complete all required trainings satisfactorily and on time.
  

Job Requirements
Qualifications

• MINIMUM REQUIREMENTS:
  Education and Experience (in years):
  • Bachelor's degree in a scientific discipline (Clinical Sciences, Health/Life Sciences, Molecular Biology, Biochemistry and/or Human Physiology), RN or BSN degree or equivalent.
  Knowledge and skills:
  • Minimum of 2 years of experience with In Vitro Diagnostic (IVD) products
  • Experience in monitoring sites, ability to prioritize and multi-task in a fast-paced environment
  • Excellent communication and team skills
  • Effective interpersonal skills
  • Proficient in Microsoft Office Applications, such as Word, Excel, Access, PowerPoint etc.
  • Experience in the handling and shipping of Bio hazardous specimens.
  • Must remain current with regulatory and clinical requirements for diagnostic products and translate the regulatory requirements into clinical trials.
  • Knowledge of GCP & ICH guidelines and FDA regulations
  • Working knowledge of the diagnostic field and clinical trial material that is to be studied
  • 30-50% travel required
  PREFERRED REQUIREMENTS:
  • Good understanding of medical terminology, human physiology and laboratory testing
  • Knowledge of regulatory and clinical practices (GCP, ICH)
  • Experience with laboratory automation and biological databases
  • Previous hands-on experience in clinical research at either a diagnostic company/hospital or laboratory
  • Knowledge of good clinical trial design, including the number and types of subjects and specimens that will be required, the conditions under which specimens must be collected, and the current gold standard for the diagnosis of disease
  • Must be detailed oriented, with strong time management and organizational skills

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Danaher Corporation Overview
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years. At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team. Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.