Job description
We are a dynamic group of professionals providing regulatory, quality and 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, in vitro diagnostics and more.
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, in vitro diagnostics and more.
We are seeking an experienced Sr. CRA 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.
MAJOR DUTIES OF POSITION:
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 remote and in-person 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 in timey 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%
KNOWLEDGE AND SKILL REQUIREMENTS:
A 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.
BS or BA in a relevant scientific discipline BS or BA degree preferred; science or related field also preferred.
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.
BENEFITS
Medical, Dental and Vision Benefits
Discretionary Bonus Program
22.5 Days of Paid Time-Off (PTO)(increases based on years of service)
10 Paid Holidays
401(k)
The above description is intended to describe the general content, identify the essential functions of, and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements.
colinoncars.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, colinoncars.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, colinoncars.com is the ideal place to find your next job.