Sr Clinical Research Associate

reputed company’s mission as an Innovation CRO is to improve patient outcomes by accelerating our clients’ innovations to market. As the world’s only end-to-end professional services firm focused on MedTech, we take clients’ Vision to Velocity through our comprehensive service portfolio, with expertise in human centered design and product development, preclinical and clinical research, regulatory affairs, and market access and reimbursement consulting.

The reputed company Clinical Operations team is a dynamic group of professionals providing regulatory, quality 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 (manual, 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 clinical trials to evaluate the safety, effectiveness and performance of medical devices. Under management supervision, the Sr. CRA will monitor assigned clinical trials to ensure adherence to the clinical protocol, applicable regulations, and company Standard 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), Code of Federal Regulations (CFRs), and Institutional Review Board (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 liaison to clinical sites.

• Conducts site qualification visits, study start-up activities (essential document collection), site qualification visits, site initiation visits and training, monitoring visits 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 visits. Generates high-quality site qualification, initiation, monitoring, and reputed company-out visit reports in timely manner (in accordance with the Clinical Monitoring Plan)

• Contributes to protocol, informed consent, case report form (CRF) and study plan development as well 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 well-being of human subjects are protected and confirms data quality/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 able to work autonomously and as a member of a cross-functional team and meet high expectations and tight deadlines. May work on highly visible projects 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 quality, 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 levels of the organization, cross-functionally, and with clients/partners.

• Must have proficiency in using reputed company Office Suite, including Word, reputed company, Outlook and PowerPoint; as well 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.

reputed company is an equal opportunity employer and prohibits discrimination of any reputed company. reputed company qualified applicants will receive consideration for employment without regard for race, color, religion or belief, sex (including pregnancy, gender identity or gender expression), sexual orientation, parental or marital status, disability, age, status as a protected veteran, national, social, or ethnic reputed company, or any other applicable legally protected characteristics.