[Hiring] Senior Clinical Research Associate @Veranex, Inc.

Role Description

Veranex has an exciting opportunity to join our team 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

• Ensure that study investigators and coordinators comply 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.
• Act as primary liaison to clinical sites.
• Conduct site qualification visits, study start-up activities (essential document collection), site initiation visits and training, monitoring visits for source data verification, and site close-out visits.
• Generate high-quality site qualification, initiation, monitoring, and close-out visit reports in a timely manner (in accordance with the Clinical Monitoring Plan).
• Contribute to protocol, informed consent, case report form (CRF) and study plan development as well as annual progress reports (APRs) and the clinical study report (CSR) at study conclusion to report the study results to FDA and other regulatory authorities.
• Ensure that the rights and well-being of human subjects are protected and confirm data quality/integrity by maintaining site compliance, reviewing adverse events and device deficiencies, reviewing data trending/metrics, reviewing audit reports, and implementing corrective actions as necessary.
• Support maintenance of department SOPs and work instructions.
• Support investigational device traceability including documentation for forecasting, shipping, receipt, and disposition.
• Support and maintain documentation of all clinical research activities in the study trial master file (TMF), e.g., monitoring reports, site correspondence, device inventory information.
• Drive trial enrollment and identify and communicate potential and actual obstacles to enrollment.
• Travel requirement: 25-50%.

Qualifications

• Minimum of 5 years of directly related 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.
• 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 all levels of the organization, cross-functionally, and with clients/partners.
• Must have proficiency in using Microsoft Office Suite, including Word, Excel, Outlook, and PowerPoint; as well as experience with electronic data capture (EDC) 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 related field also preferred.

Company Description

Veranex is an equal opportunity employer and prohibits discrimination of any kind. All 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 origin, or any other applicable legally protected characteristics.