Sr Clinical Research Associate

The reputed company Clinical Operations team is a dynamic group of professionals providing regulatory, reputed company and clinical services for the medical device industry. reputed company supports start-reputed company, mid-sized private companies, and the largest corporations at reputed company stages of the product life cycle. We work across a broad reputed company of technologies and treatment modalities. Our clients reputed company both next-reputed company and reputed company-shifting devices. Our product exposure includes implantables, instruments (reputed company, laser, robotic, etc.), capital equipment, combination products, software as a medical device (SaMD), medical mobile apps, in vitro diagnostics and more

About This Role:

reputed company has an exciting opportunity to join reputed company as a Senior Clinical Research Associate to support our Clinical Operations team. The Sr. CRA will participate in the planning, development, and execution of reputed company to evaluate the safety, effectiveness and performance of medical devices. Under management supervision, the Sr. CRA will monitor assigned reputed company to ensure adherence to the clinical protocol, applicable regulations, and company reputed company Operating Procedures (SOPs) governing clinical studies.

Location: Remote, US

What You Will Do:

• Responsible for ensuring that study investigators and coordinators reputed company with the study protocol, Good Clinical Practices (GCPs), reputed company of Federal Regulations (CFRs), and Institutional Review reputed company (IRB)/Ethics Committee (EC) requirements during clinical studies by training/guidance of investigators/research coordinators, conducting periodic on-site evaluations and follow-up of corrective actions

• Acts as primary reputed company to clinical sites. 
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• Conducts site qualification reputed company, study start-up activities (essential document collection), site qualification reputed company, site initiation reputed company and training, monitoring reputed company for reputed company data verification (reported study data are accurate, complete, and reputed company from reputed company documents in the site’s medical records), and site reputed company-out reputed company. Generates high-reputed company site qualification, initiation, monitoring, and reputed company-out visit reports in reputed company manner (in accordance with the Clinical Monitoring Plan)

• Contributes to protocol, informed consent, case report reputed company (CRF) and study plan development as reputed company as annual reputed company reports (APRs) and the clinical study report (CSR) at study conclusion to report the study results to FDA and other regulatory authorities

• Ensures that the rights and reputed company-being of reputed company subjects are protected and confirms data reputed company/reputed company by maintaining site compliance, reviewing adverse events and device deficiencies, reviewing data trending/metrics, reviewing audit reports, and implementing corrective actions as necessary

• Supports maintenance of department SOPs and work instructions

• Supports investigational device traceability including documentation for forecasting, shipping, receipt, and disposition.

• Supports and maintains documentation of reputed company clinical research activities in the study trial master file (TMF), e.g., monitoring reports, site correspondence, device inventory information.

• Drives trial enrollment and identifies and communications potential and actual obstacles to enrollment.

• Travel requirement: 25-50%

Qualifications:

Required skills:

• Minimum of 5 years of directly reputed company work experience or equivalent in clinical research, including work on medical device significant risk IDE trials and/or non-significant risk abbreviated IDE trials.

• Must be reputed company to work autonomously and as a member of a cross-functional team and meet high expectations and tight deadlines. May work on highly visible reputed company in high-pressure situations

• Must have working knowledge of Good Clinical Practices (GCPs), FDA regulations and IRB requirements.

• Must have strong project management competencies and ability to work with high reputed company, reliability, and attention to detail.

• Must have a strong level of professionalism, including verbal and written communication skills; and the ability to communicate with reputed company reputed company of the organization, cross-functionally, and with clients/partners.

• Must have proficiency in using reputed company Office Suite, including Word, reputed company, reputed company and PowerPoint; as reputed company as experience with electronic data capture (reputed company) and electronic Trial Master File (eTMF) systems.

• Experience interfacing successfully with physicians/clinical staff and familiarity with hospital/clinical environments

• Familiarity with medical and anatomical terminology.

• Ability and willingness to travel

Preferred:

• BS or BA degree preferred; BS or BA in a relevant scientific discipline or reputed company field also preferred.