Clinical Research Associate II (Remote)
Teleflex

Job Info

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Expected Travel: More than 50%

Requisition ID: 7401

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.

Interventional Urology - NeoTract is dedicated to developing innovative, minimally invasive and clinically effective devices that address unmet needs in the field of urology. As part of the Teleflex Interventional Urology business unit, NeoTract's focus is on improving the standard of care for patients with benign prostatic hyperplasia (BPH) using the UroLift® System, a minimally invasive, permanent implant system that treats symptoms while preserving sexual function*1,2. The UroLift System is clinically proven to treat lower urinary tract symptoms due to BPH in men over the age of 45. The UroLift System lifts or holds the enlarged prostate tissue out of the way so it no longer blocks the urethra. There is no cutting, heating or removal of prostate tissue. More than 175,000 men have been treated with the UroLift System in select markets worldwide.** Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.

* No instances of new, sustained erectile or ejaculatory dysfunction in the FDA pivotal study.

** Management estimate based on product sales and average units per procedure

Roehrborn, J Urology 2013 LIFT Study

McVary, J Sex Med 2014

Indicated for the treatment of symptoms of an enlarged prostate up to 100cc in men 45 years or older. As with any medical procedure, individual results may vary. Most common side effects are temporary and include pain or burning with urination, blood in the urine, pelvic pain, urgent need to urinate and/or the inability to control the urge.1 Rare side effects, including bleeding and infection, may lead to a serious outcome and may require intervention. Speak with your doctor to determine if you may be a candidate.

Position Summary

Under the supervision of the Manager, Clinical Operations, the Clinical Research Associate II will assist with study management activities from start-up to close-out, while adhering to regulations, maintaining data integrity, and aligning deliverables with corporate goals. As a member of the Clinical Operations team, this position manages and performs on-site monitoring, including investigational to post-market, single center and/or multi-center studies. This key position requires well-rounded on-site monitoring and in-house site management experience and the ability to be detailed-oriented, organized, and productive with a keen interest in medical device research.

Principal Responsibilities

• Manage all study phase functions including site launch which includes essential document management, contract execution, IRB/EC support, and patient recruitment and retention support.
• Performs clinical study site management and monitoring activities in compliance with the Protocol, ICH Good Clinical Practice, SOPs, local laws & regulations, Monitoring Plan, and other associated documents.
• Prepare for and conduct regular on-site and remote visits including qualification visits, initiation visits, monitoring visits, and close-out visits, and completes comprehensive, accurate and on-time visit reports.
• Assists in the management and shipping of study materials and resources.
• Assists with development of study specific documentation, such as CRFs and source document templates.
• Attain high-quality data and subject retention milestones through proactive site management, including leading site webinars and writing newsletters.
• Track and resolve site protocol deviations and action items, including reconciling device, equipment, and imaging media disposition.
• Ensure adherence to Adverse Event/Serious AE/SAE reporting processes, and manage CEC/DSMC charter activity and site queries.
• Identifies, assesses, and resolves site performance, quality, or compliance problems. Facilitates corrective action assessments as needed.
• Contributes to annual reports, clinical study reports, data management, data analysis, and publication support.
• Provide regular status reports or presentations to the team and support investigator meetings as needed.
• Supports study meetings, site and internal staff training, data review, and query generation.
• Collects, reviews, and monitors required regulatory documentation to maintain the TMF in audit and inspection readiness. Participates in internal and external clinical audits.
• Maintains current knowledge of applicable US and international clinical regulations, standards, and guidance documents.
• Ensures CTMS is current and capable of generating reports upon request.
• Maintain credentialing requirements at hospitals and clinics as needed.
• Complete projects and tasks consistent with corporate objectives.
• Supports the Clinical Operations team in general and with various improvement projects.
• Support the clinical department initiatives, including optimizing SOPs and on-time internal training.
• Assists with implementation and oversight of investigator initiated studies.
• Contributes to the company culture of being collaborative, respectful, transparent, ethical, efficient, high-achieving, and fun!

Education / Experience Requirements

• Bachelor degree preferably in sciences or related field, or related practical experience in the field of clinical research.
• Minimum 3 years of clinical research experience
• Minimum 2 year of clinical research monitoring experience
• US IDE and OUS experience preferred, post-market study experience is desirable.

Specialized Skills / Other Requirements

• 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, including boosters.
• Ability to foresee and prevent risks and understand when to elevate issues to management and recommend corrective action.
• Excellent time management skills.
• Ability to be detail oriented, organized and productive.
• 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 limited supervision and effectively partner with team members when necessary.
• Ability to exercise critical thinking skills in selecting methods, techniques, and evaluation criteria.
• 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.
• Ability to travel approximately 30-75% to perform training and monitoring.
• Responsible for performing all duties in compliance with FDA's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, the European Union Medical Device Regulation (MDR) and Medical Device Directive 14155, 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.

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.

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