Clinical Research Associate I

Date: Jan 24, 2023

Location: Philadelphia, PA, US

Company: Teleflex

Expected Travel: More than 50%

Requisition ID: 7656 

 

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

 

Under the supervision of the Senior Manager, Clinical Operations, the Clinical Research Associate (CRA), I will assist with site activity from site selection and 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, this position assists in study management, including investigational to post-market, single-center and/or multi-center studies, and assesses processes for efficiency and compliance. This position requires the ability to be detailed-oriented, organized, and productive, with a keen interest in medical device research.


**Position is home office based. Prefer location in the Philadelphia, PA area.

 

#LI-LP1
 

Principal Responsibilities

 

  • Assist in the management of clinical site phases of study including essential document management, contract execution, IRB/EC support, recruitment, and development of site tools. 
  • Support study meetings, training, data review, and query generation. 
  • Assist in the facilitation of corrective action assessment and reconcile site payments while ensuring protocol compliance and maintaining TMF in audit and inspection readiness. 
  • Provide status updates, ensure high follow-up rate, manage shipping and material, and develop sufficient resolution of identified action items. 
  • Conduct on-site and remote interim monitoring visits regularly to ensure adherence to monitoring plan, protocol, and regulations. 
  • Attain high-quality data and subject retention milestones through proactive site management, including leading site webinars and writing newsletters 
  • Contribute to annual reports, data management, data analysis, and publication support. 
  • Track and resolve site protocol deviations and action items, including reconciling device, equipment, and imaging media disposition 
  • Assist in assessments of SOPs annually. 
  • Maintain current knowledge of applicable US and international clinical regulations and guidance documents. 
  • Participate in department systems and development initiatives including related trainings. 
  • Provide regular status reports or presentations to the team and support investigator meetings as needed 
  • Ensure CTMS is current and capable of generating reports upon request. 
  • Support 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. 
  • Support the clinical department initiatives, including optimizing SOPs and on-time internal training.
  • Contribute to the company culture of being collaborative, respectful, transparent, ethical, efficient, high-achieving, and fun!
     

Education / Experience Requirements

 

  • Bachelor’s degree required. Prefer a BS degree in natural sciences or related field, or equivalent related practical experience in the field of clinical research. 
  • 1 year of clinical research experience required. Experience working in medical device field preferred.
  • US IDE and OUS experience preferred, post-market study experience is desirable 
  • Knowledge of interventional and cardiovascular disease state preferred 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 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.
  • Individual 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 50-75% 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.
     

TRAVEL REQUIRED: 50-75%

 

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: Philadelphia