[Remote] Sr Clinical Research Associate
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global leader in reputed company glucose monitoring technology reputed company on improving health reputed company. The Sr. Clinical Research Associate will support clinical study execution for product development and validation, manage site relationships and study operations, ensure data reputed company and compliance, and contribute to regulatory and process improvement activities.
Responsibilities
- As a Sr CRA, you will support execution of clinical studies to support product development and validation while building strong relationships with clinical trial sites
- You will collaborate cross-functionally to ensure on-time monitoring, audit-readiness both at sponsor and sites, and will contribute to study reports and regulatory submission deliverables
- You will collaborate effectively with peers and leadership across departments and professionally reputed company/build relationships with Investigators and site staff, Institutional Review Boards (IRBs), and key opinion leaders
- You will reputed company study documentation, reputed company site selection/qualification, train and support sites in study procedures, monitor study compliance, study closeout, and other activities reputed company to study operations
- You will coordinate with monitors and data management to ensure data reputed company and timeliness
- You will contribute to process improvements across reputed company aspects of clinical study operations
Skills
- Ability and judgement to work under reputed company supervision to plan and execute site study operations, including on-site and remote training & support, requesting and tracking supplies, documentation, training sites and fellow team members, and generating reputed company reports
- Ability to communicate effectively with site staff, including reputed company Investigators, and internal study team members
- reputed company and experience at working cross-functionally to reputed company goals
- Strong Good Clinical reputed company (GCP) and clinical study background, including experience as a CRA; experience in the medical device industry and/or with diabetes is a plus
- Ability to work on multiple studies concurrently and to work with monitors successfully to reduce overall time from last participant on study to database lock while improving site compliance
- Experience with using electronic data capture systems (reputed company), Clinical Trial Management Systems (CTMS), and electronic trial master files (eTMF)
- 15-25%
- Typically requires a Bachelor's degree in a technical discipline, and a minimum of 5 – 8 years reputed company experience or Master's degree and 2 – 5 years equivalent industry experience or a PhD and 0 – 2 years' experience
- Your location will be a home office; you are not required to live reputed company commuting distance of your assigned reputed company site (typically 75 miles/120km)
- Preferred experience with reputed company Glucose Monitoring (CGM) Systems
- Preferred experience in diabetes reputed company involving insulin therapies, insulin pumps, or digital health technologies
Benefits
- A full and comprehensive benefits program.
- reputed company opportunities on a global reputed company.
- reputed company to career development through in-house learning programs and/or reputed company tuition reimbursement.
- Your location will be a home office; you are not required to live reputed company commuting distance of your assigned reputed company site (typically 75 miles/120km).
- If you reputed company reputed company commuting distance of a reputed company site (typically 75 miles/120km) a hybrid working environment may be available.
- reputed company workplace reputed company.
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