Clinical Research Associate II (Based Remote US)

Date: Aug 24, 2021

Location: San Antonio, TX, US

Company: Teleflex

Expected Travel: More than 50%

Requisition ID: 4526 

 

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 Associate Director, Clinical Operations, the Clinical Research Associate II will assist with study management activities from study development, 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. This role is based remotely and can be located anywhere in the US.

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 and resources.
•    Assists with development of study-specific documentation, such as CRFs and source document templates. 
•    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 guidance 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. 
•    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’s degree preferably in sciences or related field, or related practical experience in the field of clinical research. 
•    Minimum 2 years of clinical research experience
•    Minimum 1 year of clinical research monitoring experience 
•    US IDE and OUS experience preferred, post-market study experience is desirable.

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 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 20-75% 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.  


TRAVEL REQUIRED: 20-75%

 

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: San Antonio