Website CYNET SYSTEMS
CYNET SYSTEMS
Company : CYNET SYSTEMS
Job Description:
Responsibilities:
- Perform on site or remote monitoring visits including qualification, initiation, interim monitoring, and close out and complete reports as per study monitoring plan.
- Build and maintain successful working relationships with internal partners such as clinical functions, regulatory affairs, quality assurance, research and development, and investigational site staff such as investigators, research nurses, and coordinators.
- Resolve case report form discrepancies.
- Review and report adverse events, serious adverse events, and protocol deviations per industry standards.
- Review documentation for ALCOA standards.
- Assist with site remediation activities as applicable.
- Ensure sites maintain an acceptable inventory and accountability of study devices and clinical supplies.
- Communicate clearly and effectively with study sites.
- Comply with investigative sites confidentiality requirements for monitors.
- Complete and maintain relevant global medical and clinical affairs, business unit specific, and study specific training.
Qualification And Education:
- Bachelor s degree or higher in a healthcare or science related field.
- Clinical background strongly preferred such as registered nurse, nurse practitioner, or other licensed healthcare professional.
- Consideration of alternate education will be case dependent based on experience and positional need.
Experience:
- Five or more years of relevant clinical research experience as a field based clinical research associate in the device or pharmaceutical industry including multi phase business knowledge of medical device or pharmaceutical product development.
- Medical device experience required.
- Ability to travel up to fifty percent.
Skills:
- Superior written and verbal communication skills.
- Proficiency in presentation preparation and delivery.
- Technical savviness with the ability to understand the impact technology has on increasing effectiveness and performance.
- Working knowledge of clinical trial management processes and systems including monitoring, investigational product handling, and data management.
- Working knowledge of domestic and international clinical research guidelines such as ICH GCP, FDA CFR, ISO, and HIPAA.
- Ability to work in and promote team cohesiveness in a virtual or remote environment.
- Demonstrated ability to prioritize multiple tasks with competing timelines and deliverables.