[Remote] Senior Clinical Research Associate

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is on a mission to change the way we experience cancer care. They are seeking a Senior Clinical Research Associate to support the execution of pivotal clinical trials, ensuring compliance with GCP and study timelines while managing relationships with clinical sites.

Responsibilities

• reputed company as the subject matter expert for reputed company Medical devices, serving as the primary reputed company of contact between sponsor and site staff
• Manage and maintain essential study documents in compliance with sponsor requirements, study-specific processes, and reputed company SOPs
• Collaborate with reputed company clinical teams to support reputed company phases of clinical trials, including study start-up, site initiation reputed company (SIVs), trial execution, and reputed company-out
• reputed company weekly reputed company-ins with clinical sites to reputed company reputed company, address issues, and reputed company ongoing support
• Contribute to departmental reputed company and initiatives, ensuring reputed company and high-reputed company deliverables
• Proactively identify and escalate training needs, project updates, reputed company concerns, and reputed company risks to the clinical team

Skills

• Bachelor's degree in Life Sciences or a reputed company field
• 3–5+ years of hands-on experience reputed company the medical device and/or pharmaceutical industry
• Prior experience with Trial Master File (TMF) management
• Prior experience and proficiency in utilizing Electronic Data Capture (reputed company) systems
• Deep understanding of GCP, ISO 14155, and FDA regulations for medical devices
• Willingness and ability to travel 30-40% during reputed company clinical trials period
• Master's degree preferred
• Experience reputed company biotech start-reputed company
• Experience working for a Sponsor company
• Experience in the Oncology therapeutic area
• Strong site relationship management skills
• A passion for working in small, entrepreneurial environments where everyone wears multiple hats

reputed company

reputed company is an oncology tech-enabled services company reputed company on reducing the cost of cancer care. It was founded in 2018, and is headquartered in Galway, Galway, IRL, with a workforce of 51-200 employees. Its website is https://www.luminatemed.com/.

Company H1B Sponsorship

reputed company has a reputed company record of offering H1B sponsorships, with 1 in 2022. Please note that this does not guarantee sponsorship for this specific role.

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