Clinical Research Associate in Danvers, Massachusetts at Leica Biosystems

Date Posted: 11/17/2019

Job Snapshot

Job Description

Job ID: ADV001160

About Us

Leica Biosystems is a global leader in workflow solutions and automation. As the only company to own the workflow from biopsy to diagnosis, we are uniquely positioned to break down the barriers between each of these steps.  Our mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of our corporate culture. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. The company is represented in over 100 countries. It has manufacturing facilities in 9 countries, sales and service organizations in 19 countries, and an international network of dealers. The company is headquartered in Nussloch, Germany. Visit LeicaBiosystems.com  for more information.

Leica Biosystems Imaging, Inc. is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.
All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check. 

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Description

The Clinical Research Associate prepares and executes clinical operations study tasks, including: documents (may include plan, protocol, report); initiation, monitoring, and completion of clinical studies for verification and/or validation. 

This position represents the Global Clinical Affairs group on multi-functional core teams to ensure project requirements are met and clinical trials are conducted successfully. Ensures adherence to Good Clinical Practice (GCP) and department standard operating procedures for conducting device clinical studies.

Major Responsibilities 
  • Under supervision of the Clinical Program Lead, works with relevant departments (R&D, Regulatory Affairs, Product Support, Program Management, Marketing) to aid in design and preparation of clinical and analytical performance study plans, protocols, and reports, statistical data analysis plans, and associated study data collection forms. 
  • With minimum supervision, completes all activities related to the set-up, initiation, execution and close-out of device clinical trials including, site selection, collection and timely review and analysis of data generated. 
  • Schedules and completes on-site monitoring visits to ensure protocol compliance, accuracy and completeness of clinical data.
  • Communicates with study investigators via phone, fax, email, onsite and/or letters regarding activities in all phases of the study. Develops and maintains ongoing relationships with investigators/institutions/vendors with access to specimens needed in clinical trials.
  • Leads the development, organization, implementation and completion of clinical studies according to FDA standards and Good Clinical Practice (GCP). Provides technical training and monitoring; coordinates daily activities of trial sites; assists sites on planning and implementing subject recruitment activities.
  • Educates and assists sites to ensure timely subject screening and enrollment
  • Conducts assessments of complications and serious adverse events, including reviewing and reconciling data and documentation related to the event.
  • Conducts quality control to ensure compliance to the study protocol, trial material storage and accountability.
  • Supports IRB submissions, addendums and renewals.
  • Provides technical support and training to clinical investigators and their staff in regard to device trial information, the protocol, clinical and regulatory requirements and device implant support.
  • Contributes to the submission of clinical data and study reports to support regulatory submissions.
  • Assists in evaluation and analysis of clinical data.
  • Remains current with regulatory requirements for in-vitro diagnostic and medical device products.
  • Completes the coordination with biostatisticians and data managers to manage incoming clinical site data, design/maintain databases, and ensure integrity of the database.
  • Provides up-to-date clinical study progress reports.
  • Negotiates site specific study budgets, initiates and oversees contract origination, compliance approval, and execution. Completes the tracking of budgets for studies.
  • Represents Global Clinical Affairs on multi-functional teams tasked with preparing responses to regulatory agencies.

Job Requirements



Qualifications

Required Skills/Experience/Education
  • Minimum of a Bachelor Degree in a related Scientific field or equivalent; minimum of two years' related experience and/or training; or equivalent combination of education and experience.
  • GCP Trained
  • Excellent communication skills, both verbal and written
  • Excellent interpersonal skills, including negotiation skills
  • Excellent organizational skills
  • Knowledge of regulatory requirements for in-vitro diagnostic and medical device products
  • Working knowledge of databases (e.g., Excel, Access), database management, and statistical applications
  • Good knowledge of the in-vitro diagnostics and medical device industry preferred
  • Good technical background to understand and communicate current and new technologies
  • Laboratory experience is desirable
  • Ability to work on multiple projects simultaneously
Travel
  • 30% -40% Travel Required
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Diversity & Inclusion
At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page—Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.


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.