Sr. Clinical Research Associate - Remote

Date: Mar 30, 2021

Location: Morrisville, NC, US

Company: Teleflex

Expected Travel: More than 50%

Requisition ID: 3431 

 

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

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 Global Clinical Operations team, this position develops and assesses SOPs, assesses processes for efficiency and compliance. This position requires the ability to be detail-oriented, organized, and productive with a keen interest in medical device and biologics research.

Principal Responsibilities

Independently manage all phases of a clinical study including protocol, CRF, and monitoring plan 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, as needed.
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.
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 Operations 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, medical device experience preferred. 
US IDE, IND, and OUS experience desirable.
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-level 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, such as Access, etc.
Ability to develop strong relationships with investigative sites.

Specialized Skills / Other Requirements

Language and Verbal Skills:

Excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally.


Math Skills:

Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.


Analytical and Reading Skills:

Ability to read, understand and abide by company procedures. Ability to define problems, collect data, establish facts, draw valid conclusions and report on findings. 


Physical Requirements:

The physical demands and work environment described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk and hear; up to 8 hours per day. The employee is regularly required to lift and carry up to 10 pounds and occasionally lift and carry up to 25 pounds. Duties also involve daily keyboard data entry. Specific vision abilities required by this job include close vision. 


TRAVEL REQUIRED: 20 - 75%

Ability to travel approximately 20-75% to attend meetings, perform training and monitoring.

 

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: Raleigh