Clinical Research Associate

Date: Apr 10, 2021

Location: Pleasanton, CA, US

Company: Teleflex

Expected Travel: Up to 25%

Requisition ID: 3563

 

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

  1. Roehrborn, J Urology 2013 LIFT Study
  2. 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 Clinical Project Manager, the Clinical Research Associate will assist with study management activities from site selection and 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 assists in the development of SOPs, the assessment of processes for efficiency and compliance, and the coordination of assigned research studies. This position requires the ability to be detailed-oriented, organized, and productive with a keen interest in medical device research and urology.

Principal Responsibilities

•    Acts as site manager and primary contact throughout all study phases, and takes overall responsibility of allocated sites 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.
•    Assists in the development, management and shipping of study materials.
•    Supports study meetings, site and internal staff training, data review, and query generation. 
•    Identifies, assesses, and resolves site performance, quality, or compliance problems. Facilitates corrective action assessments as needed. 
•    Coordinates and reconciles site and vendor payments. 
•    Collects, reviews, and monitors required regulatory documentation to maintain the TMF in audit and inspection readiness. Participates in internal and external clinical audits. 
•    Provides site status updates, ensures enrollment and subject retention milestones are met, identifies risks and escalates when appropriate, and develops sufficient resolution of identified action items. 
•    Conducts 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. 
•    Contributes to annual reports, data management, data analysis, and publication support. 
•    Maintains current knowledge of applicable US and international clinical regulations, standards, and guidances documents. 
•    Supports investigator meetings as needed. 
•    Ensures CTMS is current and capable of generating reports upon request. 
•    Supports Protocol Deviation and Adverse Event review and reporting. 
•    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. 
•    Performs other duties as assigned. 
•    Contributes to the company culture of being collaborative, respectful, transparent, ethical, efficient, high-achieving, and fun!

Education / Experience Requirements

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

Specialized Skills / Other Requirements

•    Knowledge of urology and BPH disease state or willingness to undergo rigorous and fast learning independently. 
•    Ability to foresee and prevent risks and understand when to elevate issues to management and recommend corrective action. 
•    Excellent time management 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 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 20-75% to perform training and monitoring. 
•    Valid driver’s license issued by the state in which the individual resides. 
 

 

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.


Nearest Major Market: San Francisco
Nearest Secondary Market: Oakland