Sr. Clinical Research Associate (Remote)

Date: Oct 19, 2021

Location: Pleasanton or Remote, CA, US

Company: Teleflex

Expected Travel: Up to 50%

Requisition ID: 4699

 

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

The Sr. Clinical Research Associate (Sr. CRA) manages study activity from site selection, start-up, to close-out with adherence to regulations, maintaining data integrity, and aligning deliverables with corporate goals. As a key contributor to the Clinical Affairs team, this position develops and assesses SOPs, assesses processes for efficiency and compliance, and mentors other junior CRAs. This position requires the ability to be detailed-oriented, organized, and productive with a keen interest in medical device research.

Principal Responsibilities

•    Independently manage all phases of a clinical study including protocol and CRF development, essential document management, contract execution, IRB/EC support, recruitment, site payment reconciliation and development of site tools. 
•    Conducts Qualification, Site Initiation, Interim, and Close-Out monitoring visits to ensure adherence to monitoring plan, protocol, and regulations. 
•    Train site personnel regarding the protocol and applicable regulatory requirements.
•    Ensure each site is meeting its goals of follow-up rate, data clean deadlines, protocol compliance, and enrollment.
•    Lead study meetings to ensure completion of established project team goals and objectives, including study training and data review. 
•    Facilitate corrective action assessment and maintain TMF in BIMO readiness. 
•    Provide study status updates to Management team and develop sufficient resolution of identified action items. 
•    Contribute to annual reports, data management, data analysis, and publication support. 
•    Develop and assesses SOPs annually. 
•    Monitor emerging trends to help integrate new requirements into department procedures. 
•    Maintain current knowledge of applicable US and international clinical regulations and guidance documents. 
•    Participate in department systems and development initiatives including related trainings. 
•    Support investigator meetings as needed. 
•    Ensure CTMS is current and capable of generating reports upon request. 
•    Support 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. 
•    Support the Clinical Affairs team in general and with various improvement projects. 
•    Perform other duties as assigned. 
•    Contribute 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. 
•    At least 7 years of clinical research experience preferably in medical devices. 
•    US IDE and OUS experience required, post-market study experience is desirable. 
•    Knowledge of urology and BPH 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. 
•    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, Excel, and Access 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