Clinical Research Coordinator (Oncology) in High Wycombe, United Kingdom at Cepheid

Date Posted: 5/11/2018

Job Snapshot

Job Description

Job ID: CEP001042

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 www.cepheid.com or follow us on Twitter (@CepheidNews).


Description

ESSENTIAL JOB RESPONSIBILITIES: 



  • Responsibilities include all operational activities for new and/or ongoing cancer diagnostic test product clinical evaluations.He/she will be responsible for all activities of the clinical studies including clinical site selection, study initiation visits, training of on-site personnel, study close-out visits and trial monitoring with on-site audits of clinical data for accuracy and completeness, and clinical report preparation and presentation.

  • He/she will identify potential investigators, prepare site budgets and contract agreements, prepare study protocols and investigator manuals, site specific instruction manuals, and design case report forms for new and modified products. He/ she will support Market Access and MSASO team members with fostering strong relationships with European experts in disease areas relevant to the Cepheid Oncology Pipeline of Products (CML, Bladder Cancer, Breast Cancer, Prostate Cancer)

  • He/she will assist with the management of key study parameters (i.e. study master files, start-up activities, preparation of precision study specimens, data collection and data analysis, etc.)

  • He/she will be responsible for timely identification of problems or issues that could affect the results or timely completion of the study, or any protocol deviations, and for suggesting mechanisms for solving the problem.

  • He/she will stay up to date on major advances in cancer detection, diagnosis, and monitoring and the use of new tests and advances in clinical practice

Job Requirements



Qualifications

MINIMUM REQUIREMENTS:



  • The ideal candidate will have the following:

    • Bachelor's or Master’s degree in a scientific discipline (Clinical Sciences, Health/Life Sciences, Molecular Biology, Biochemistry and/or Human Physiology), nursing degree or equivalent.

    • Minimum of 3-4 years of experience with In Vitro Diagnostic (IVD) products.

    • Excellent English language skills, written and spoken, additional European languages a plus

    • Experience in monitoring sites, ability to prioritize and multi-task in a fast-paced environment.

    • Excellent communication and team 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.

    • Familiar with clinical literature in field of study and related areas

    • Good understanding of cancer biology and molecular diagnostics

30-50% travel required within Europe





PREFERRED REQUIREMENTS (optional):


Good understanding of medical terminology, human physiology and laboratory testing
Experience with laboratory automation and clinical databases
Previous hands-on experience in clinical research at either a diagnostic company or hospital
Proficient 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 that disease



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, dental, environmental and applied solutions. Our globally diverse team of 62,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $16.9B in revenue last year. We are ranked #133 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,300% over 20 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.