Sr Clinical Research Associate/Clinical Research Associate II - (Remote) ID-14446
Veranex is the leading service provider for medtech companies. Our global team of experts help clients anticipate challenges and find solutions throughout the development and commercial lifecycle. Together, we accelerate new technologies to market and improve patient outcomes.
Sr Clinical Research Associate/Clinical Research Associate II - (Remote)
About This Role:
Veranex has an exciting opportunity to join our team as a Senior Clinical Research Associate or Clinical Research Associate II to support our Clinical Operations team. You will participate in the planning, development, and execution of clinical trials to evaluate the safety, effectiveness and performance of medical devices. You will monitor assigned clinical trials to ensure adherence to the clinical protocol, applicable regulations, and company Standard Operating Procedures (SOPs) governing clinical studies.
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Primary Responsibilities:
- 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 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 a 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 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 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.
- In addition to the above, please see the direct responsibilities for both Senior and Level II below
(Sr. CRA Responsibilities)
- Leads the development and maintenance of department SOP's and work instructions.
- Drives study enrollment identifiers and communicates potential and actual obstacles to enrollment.
- Leads site qualification visits, study start-up activities (essential document collection), site initiation visits and training, monitoring visits for source data verification (reported
- study is accurate, complete and verifiable from source documents in the site's records), and site close-out visits.
- Leads the investigational device availability/traceability including documentation for forecasting, shipping, receipt, and disposition.
- Leads audit/inspection activities as needed.
(Level II CRA Responsibilities)
- Develops and maintains department SOP's and work instructions.
- Develops study documentation, e.g. protocol, informed consent, case report from (CRF) and study specific plans as well as annual progress reports (APRs) and the clinical study report (CSR).
Qualifications
Required skills:
Clinical Research Associate II:
-
- 2-4 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
Sr. Clinical Research Associate:
-
- 4+ 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
- Ability to work independently, demonstrating full understanding of clinical studies
- Led clinical studies to include ensuring the studies are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), good clinical practice (GCP), and all applicable regulatory requirements.
Required skills (both levels):
-
- Must be able to work autonomously and as a member of a cross-functional team and meet high expectations and tight deadlines
- Ability to work on highly visible projects in high-pressure situations
- Working knowledge of Good Clinical Practices (GCPs), FDA regulations and IRB requirements
- Strong project management competencies and ability to work with high quality, reliability, and attention to detail
- 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
- 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.
- Must be able and willing to travel 25-50%
Preferred: • BS or BA degree preferred; BS or BA in a relevant scientific discipline or related field also preferred.
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.
