Clinical Research Associate Ii (Remote)

Position Summary

Under the supervision of the Senior Manager, Clinical Operations, the Clinical Research Associate II 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.

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

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Principal Responsibilities

• Ensure adherence to Adverse Event/Serious AE/SAE reporting processes, and manage CEC/DSMC charter activity and site queries.
• 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.
• Contributes to the company culture of being collaborative, respectful, transparent, ethical, efficient, high-achieving, and fun!
• Attain high-quality data and subject retention milestones through proactive site management, including leading site webinars and writing newsletters.
• Complete projects and tasks consistent with corporate objectives.
• Track and resolve site protocol deviations and action items, including reconciling device, equipment, and imaging media disposition.
• Collects, reviews, and monitors required regulatory documentation to maintain the TMF in audit and inspection readiness. Participates in internal and external clinical audits.
• Contributes to annual reports, clinical study reports, data management, data analysis, and publication support.
• Supports study meetings, site and internal staff training, data review, and query generation.
• Provide regular status reports or presentations to the team and support investigator meetings as needed.
• Supports the Clinical Operations team in general and with various improvement projects.
• Identifies, assesses, and resolves site performance, quality, or compliance problems. Facilitates corrective action assessments as needed.
• Assists in the management and shipping of study materials and resources.
• Maintains current knowledge of applicable US and international clinical regulations, standards, and guidance documents.
• Prepare for and conduct regular 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.
• Assists with development of study specific documentation, such as CRFs and source document templates.
• Manage all study phase functions including site launch which includes essential document management, contract execution, IRB/EC support, and patient recruitment and retention support.
• Support the clinical department initiatives, including optimizing SOPs and on-time internal training.
• Ensures CTMS is current and capable of generating reports upon request.
• Assists with implementation and oversight of investigator initiated studies.

Education / Experience Requirements

• Minimum 2 year of clinical research monitoring experience. Experience working in medical device field preferred.
• US IDE and OUS experience preferred, post-market study experience is desirable
• Minimum 3 years of clinical research experience
• Knowledge of interventional and cardiovascular disease state preferred or willingness to undergo rigorous and fast learning independently.
• 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.

Specialized Skills / Other Requirements

• Excellent time management skills.
• Must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally.
• Ability to be detail oriented, organized and productive.
• Ability to travel 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.
• Ability to develop strong relationships with investigative sites.
• Ability to perform at high-levels with limited supervision and effectively partner with team members when necessary.
• Ability to foresee and prevent risks and understand when to elevate issues to management and recommend corrective action.
• 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.
• Ability to exercise critical thinking skills in selecting methods, techniques, and evaluation criteria.
• 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 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.
• Proficient in Microsoft Word and Excel and the ability to quickly learn other software tools and applications.
• 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.

TRAVEL REQUIRED: 50-75%

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