Clinical Research Coordinator (hybrid)
Teleflex

Job Info

---

Expected Travel: None

Requisition ID: 7834

About Teleflex Incorporated

Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people's lives. We apply purpose driven innovation - a relentless pursuit of identifying unmet clinical needs - to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.

Global Functions - The Corporate division is the central operating unit of the company; setting strategy and policy and providing business development, finance, human resources, information technology, investor relations and legal support to the businesses. The global Company headquarters is located just outside of Philadelphia in Wayne, PA. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.

Position Summary

The Clinical Research Coordinator (CRC) will assist in coordination of administrative and financial aspects of study implementation and management from start-up to close-out with adherence to regulations, maintaining data integrity, and aligning deliverables with corporate goals. As a member of the Clinical Operations team, the coordinator will support day to day operations including, collection and maintenance of study files, data review and will provide regular updates on study progress. This position requires the ability to be detailed-oriented, organized, and productive with a keen interest in medical device research and interventional products.

**Position is hybrid home and office based. 2-3 days per week in the office. Office location Maple Grove MN.

Principal Responsibilities

• Assist in the management of clinical site phases of study including essential document management, IRB/EC support, and recruitment.
• Support study meetings and preparation, data review, and query generation.
• Assist with study invoice submission and tracking site payments.
• Ensure coordination, organization and maintenance of study files, essential documents and device accountability ensuring protocol compliance and maintaining TMF in audit and inspection readiness.
• Provide status updates, ensure high follow-up rate, and manage material shipping.
• Assist in on-site and remote monitoring visits regularly to ensure adherence to monitoring plan, protocol, and regulations.
• Contribute to development of study materials and assist with annual reports, data management and analysis.
• Maintain current knowledge of applicable US and international clinical regulations and guidance documents.
• Ensure CTMS is current and capable of generating reports upon request.
• Assist with management of Protocol Deviation, Device Deficiency and Adverse Event review and reporting.
• Complete projects and tasks consistent with corporate objectives.
• Support the Clinical Operations team in general and with various improvement projects.
• Contribute to the company culture of being collaborative, respectful, transparent, ethical, efficient, high-achieving, and fun!

Education / Experience Requirements

• Minimum of Associates degree required. Bachelor's degree strongly preferred preferably in natural sciences or related field, or practical related practical experience.
• Previous experience supporting clinical research or similar technical/scientific field strongly preferred.
• Knowledge of interventional and cardiovascular disease state or willingness to undergo rigorous and fast learning independently.

Specialized Skills / Other Requirements

• Ability to foresee and prevent risks and understand when to elevate issues to management and recommend corrective action
• Excellent time management skills along with strong attention to detail and strong organization skills
• Ability to recognize potential obstacles and develop solutions to resolve them with minimal consequence within set timelines or change direction if priorities are modified
• Ability to make critical, independent decisions and be accountable for actions within a fast-moving environment
• Ability to perform at high-levels with supervision and effectively partner with team members when necessary
• Proficient in Microsoft Word and Excel and the ability to quickly learn other software tools and applications
• Ability to develop strong relationships with investigative sites
• Responsible for performing all duties in compliance with FDA's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which Teleflex complies.
• Must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally
• Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations
• Ability to read, understand and abide by company procedures. Ability to define problems, collect data, establish facts, draw valid conclusions and report on findings.
• Must be able to establish and maintain vendor credentials (via RepTrax, Vendormate, etc) to have the ability to enter and work, as required, in hospitals and other medical facilities, as an essential function of the job. Depending on customer/site requirements, vendor credentials may require the employee to obtain the COVID-19 vaccination, and boosters.
• Ability to travel approximately 30-50% to perform training and monitoring. Travel varies based on study support. Will include overnight stays. Must be able to travel in the US and internationally.

#LI-GL1

Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 262-439-1894.

Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® - trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.

© 2021 Teleflex Incorporated. All rights reserved.

This job has expired.