Clinical Research Associate Manager (REMOTE) jobs in United States
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Teleflex · 1 day ago

Clinical Research Associate Manager (REMOTE)

Teleflex is a global provider of medical technologies focused on improving health and quality of life. The CRA Manager will lead a team of Clinical Research Associates, overseeing study activities and ensuring compliance with regulations while contributing to the Global Clinical Operations team.

CommercialHealth CareMedicalMedical Device
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H1B Sponsor Likelynote
Hiring Manager
Lexy (Mayer) Cianfrani
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Responsibilities

Manage a team of in-house and regional CRAs, providing guidance on study conduct, clinical operational and monitoring strategy, as well as professional growth
Serve as primary point of contact for CRA escalations and issue resolution across assigned studies
Partner with Clinical Project Managers and cross functional teams to support 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

Qualification

Clinical research experienceCRA management experienceMicrosoft WordMicrosoft ExcelUS IDE/IND experienceCommunication skillsTime management skillsCritical thinking skillsProblem-solving skills

Required

Bachelor of Science degree required. Preferably in natural sciences or related field, or related practical experience
Minimum 8 years of clinical research experience, medical device experience preferred. This should includes a minimum of 3 years in a CRA management, or lead CRA capacity
Proficient in Microsoft Word and Excel, and the ability to quickly learn other software tools and applications, such as Access, etc
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
Ability to develop strong relationships with investigative sites
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

Preferred

US IDE, IND, and OUS experience preferred

Benefits

Medical
Prescription drug
Dental and vision insurance
Flexible spending accounts
Participation in 401(k) savings plan
Various paid time off benefits, such as PTO
Short- and long-term disability
Parental leave

Company

Teleflex

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Teleflex is a manufacturing company that designs and develops medical devices for the healthcare sector.

H1B Sponsorship

Teleflex has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (2)
2023 (3)
2022 (2)
2021 (4)
2020 (1)

Funding

Current Stage
Public Company
Total Funding
$400M
2016-05-12Post Ipo Debt· $400M
1990-01-01IPO

Leadership Team

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Liam Kelly
Chairman, President and CEO
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Cameron Hicks
Corporate Vice President and Chief Human Resources Officer
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Company data provided by crunchbase