Senior Clinical Research Associate
New
V
VeranexMedical devices
Location: Remote, USFull-TimeSenior
Salary98,400 - 140,690 USD per year
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Job Details
- Experience
- Minimum of 5 years of directly related work experience or equivalent in clinical research
- Required Skills
- Project ManagementMicrosoft Office
Requirements
- Have a minimum of 5 years of directly related clinical research experience or equivalent.
- Have experience with medical device significant-risk IDE trials and/or non-significant-risk abbreviated IDE trials.
- Have working knowledge of Good Clinical Practices, FDA regulations, and IRB requirements.
- Demonstrate project management competencies and the ability to work with quality, reliability, and attention to detail.
- Be able to work autonomously and as part of a cross-functional team and meet tight deadlines.
- Have strong verbal and written communication skills and the ability to communicate across organizational levels and with clients and partners.
- Be proficient with Microsoft Office Suite, including Word, Excel, Outlook, and PowerPoint.
- Have experience with electronic data capture (EDC) and electronic Trial Master File (eTMF) systems.
- Have experience interfacing with physicians and clinical staff and familiarity with hospital or clinical environments.
- Be familiar with medical and anatomical terminology.
- Be able and willing to travel 25–50%.
- A BS or BA degree is preferred, particularly in a relevant scientific discipline or related field.
Responsibilities
- Train and guide investigators and research coordinators on protocol, GCP, CFR, and IRB/Ethics Committee requirements.
- Conduct periodic on-site evaluations and follow up on corrective actions.
- Act as the primary liaison to clinical sites.
- Conduct site qualification, study start-up, initiation, monitoring, and close-out activities, including source data verification.
- Prepare timely, high-quality site visit reports in accordance with the Clinical Monitoring Plan.
- Contribute to protocol, informed consent, CRF, study plan, annual progress report, and clinical study report development.
- Review adverse events, device deficiencies, data trends, and audit reports, and implement corrective actions as needed.
- Support department SOPs and work instructions, investigational device traceability, and study TMF documentation.
- Drive trial enrollment and communicate potential and actual enrollment obstacles.
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