Sr Clinical Research Associate

Veranex; Raleigh, Northern (NC, KY); Hybrid; USD 95,000 - 140,000; Full time

Job summary

Veranex seeks a Senior Clinical Research Associate to join our Clinical Operations team. The Sr. CRA will help plan, develop, and execute clinical trials to evaluate safety and performance of medical devices, monitoring sites to ensure protocol and regulatory compliance under SOPs.

The role requires at least 5 years in clinical research, strong knowledge of GCP/FDA/IRB, and excellent communication. Travel up to 50% may be required, with remote US work available through Veranex’s clinical

Qualifications

• Minimum 5 years of clinical research experience, with device IDE trials.
• Ability to work autonomously and as part of a cross-functional team under tight deadlines.
• Strong knowledge of GCP, FDA regulations and IRB requirements.
• Excellent project management, reliability, and attention to detail.
• Professional communication skills, both written and verbal, across all levels of the organization.
• Experience with EDC and eTMF systems and MS Office Suite.
• Willingness to travel 25-50%.

Responsibilities

• Ensure study investigators and coordinators comply with the protocol, GCPs, CFRs, and IRB/EC requirements during clinical studies through training and guidance.
• Serve as primary liaison to clinical sites.
• Conduct site qualification visits, startup activities, monitoring visits, and close-out visits with thorough reports.
• Contribute to protocol, informed consent, CRF and study plan development, plus APRs and CSR at study end to report results to FDA and regulators.
• Protect rights and well-being of subjects; monitor data quality and implement corrective actions as needed.
• Maintain department SOPs and TMF documentation; support device traceability.
• Drive trial enrollment and identify obstacles to enrollment.
• Travel requirement: 25-50%.

Skills

GCPs

FDA regulations

IRB requirements

Project management

Communication skills

MS Office

EDC

eTMF

Education

BS or BA in a scientific discipline

Tools

EDC

eTMF

Microsoft Office Suite

Job description

TheVeranexClinicalOperationsteam is a dynamicgroup of professionals providing regulatory,qualityand clinical services for the medical device industry. Our team supports start-ups, mid-sized private companies, and the largest corporations at all stages of the product life cycle. We work across a broad spectrum of technologies and treatment modalities. Our clients develop both next-generation and paradigm-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, invitrodiagnostics and more

About This Role

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

• Responsible for ensuring 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
• 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 source data verification (reported study data are accurate, complete, and verifiable from source documents in the site’s medical records), and site close-out visits. Generates high-quality site qualification, initiation, monitoring, and close-out visit reports intimately 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 progress 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/integrity 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 all 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 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. 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 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.