Clinical Research Associate

Expected Travel: More than 50%

Requisition ID: 12746 

About Teleflex Incorporated

As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare. 
 
Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.
 
At Teleflex, we are empowering the future of healthcare.  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 Clinical Trial Manager, Clinical Operations, the Clinical Research Associate 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 complete comprehensive, accurate, and on-time visit reports. 
•    Assists in the management and shipping of study materials and resources.
•    Assists with the 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-specific and drafting newsletters. 
•    Track and resolve site protocol deviations and action items, including reconciling devices, equipment, and imaging media disposition.
•    Ensure adherence to Adverse Event/Serious AE/SAE reporting processes and manage 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. Participate 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. 
•    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.

Education / Experience Requirements

•    Bachelor’s degree required. Prefer a BS degree in natural sciences or related field, or equivalent related practical ex