Description
As a Senior Clinical Research Associate - Surgical Device - Central Region at ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's global expertise.
You will lead on clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement. Key responsibilities include:
- Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
- Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
- Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
- Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
- Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.
You will have a strong foundation in clinical trial monitoring, with the experience of working independently and guiding others. Required qualifications and experience:
- A bachelor's degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing, or Biological Science.
- 3-5 years of CRA monitoring experience in CRO/pharma environments.
- Strong preference for at least 1 year of medical device monitoring experience; however, complex pharma monitoring experience will be considered.
- In-depth knowledge of FDA regulations and ICH/GCP guidelines.
- Strong problem-solving skills to mitigate risks and identify issues at sites and implement effective solutions promptly.
- Strong interpersonal skills to establish and maintain effective working relationships with site personnel, investigators, and internal teams.
- Exceptional verbal and written communication skills, with the ability to convey complex information clearly and concisely.
- Ability to tailor communication style to the needs and preferences of different stakeholders, fostering a collaborative environment.
- Ability to work independently and manage multiple priorities in a dynamic environment.
- A well-executed plan for communication with the study teams and sites.
- Well-versed in clinical trial management; rigorous, detail-oriented, and precise in reports.
- Willingness to travel as required (approximately 60%).
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
- Competitive base salary and performance-related incentives.
- Health and wellbeing programmes, including medical, dental, and vision coverage where applicable.
- Retirement and pension plans.
- Life assurance and disability coverage.
- Employee assistance programmes and wellbeing resources.
- Learning and development opportunities through structured training and career pathways.