- Works in Medical Device - To support 1-3 protocols in the neurovascular space.
- Demonstrated leadership, through involvement in specific initiatives when needed, and/or SME to systems and/or processes
- Mentors/coaches junior flex team
- Acts as Lead SM-training other SMs on study
- Develops site start up documents for studies including SIV agenda
- Provides SM "voice" when reviewing study documents (e.g. Monitoring Guidelines)
- Represents LTMs or SMs on SMTs/meetings
- Supports country budget development and/or contract negotiation in liaison with CCS colleagues
- Assists with ASV
- Metrics/KPIs: Metrics/KPIs governing these services are outlined in the Quality Oversight Plan (QOP) document.
- Primary interfaces: Provider Functional Manager, Clinical Trial Assistant, Local Trial Manager and Central Study Team for assigned clinical trials.Other Interfaces: Study Responsible Physician, Regional Quality and Compliance. Manager/Specialist, Local Drug Safety Officer (where required) and Site Manager team; Investigators and their delegates at site (trial personnel including study coordinators, pharmacists, etc.
- Bachelor Degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science.
- Have a minimum of 3 years' experience in monitoring medical device or pharmaceutical industry clinical trials*
- Medical Devices monitoring preferred; however, strong neurovascular pharma monitoring experience will be considered in lieu of Med Device experience.
- Analytical/risk-based monitoring experience is an asset
- Ability to actively drive patient recruitment strategies at assigned sites
- Ability to partner closely with investigator and site staff to meet all of our study timelines
- Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting).
- Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and self-starter with the ability to work independently.
- Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements.
- Need to travel up to 50%
- To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.
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Senior Clinical Research Associate - Kentucky, United States - PRA Health Sciences
4 weeks ago
Description
Overview
As a Sr CRA you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Responsibilities
What will you be doing?
Interfaces – Primary/Other:
Qualifications
What do you need to have?
Why ICON?
Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
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