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Full-Time

Senior Clinical Research Associate

Posted on 6/27/2024

ReCor Medical

ReCor Medical

201-500 employees

Ultrasound renal denervation technology provider

Hardware

Compensation Overview

$105k - $138kAnnually

Senior, Expert

Remote in USA

Category
Lab & Research
Life Sciences
Medical Research
Biology & Biotech
Required Skills
Communications
Requirements
  • Bachelor’s Degree or international equivalent in medical or scientific related discipline preferred.
  • Minimum of 5 years monitoring related experience. Experience in medical device trials preferred.
  • Clinical Research Associate certification preferred.
  • Strong attention to detail and organizational skills.
  • Excellent presentation, verbal, and written communication skills.
  • Technical expertise including Teams, Word, Excel, eTMF and CTMS preferred.
Responsibilities
  • Mentors junior team members, on-boarding and training related to core responsibilities.
  • Participates in and may lead regular monitoring team meetings to share best practices, identify process improvements, and create consistency across monitoring team.
  • Supports the evaluation of clinical sites for possible participation in ReCor projects.
  • Supports site qualification and initiation visits and ad-hoc trainings of site team members, as needed.
  • Schedules, prepares for, and conducts interim monitoring visits and close-out visits.
  • Monitors study data and verifies source documentation for accuracy and completeness.
  • Collaborates with sites and cross-functional teams to resolve data queries.
  • Collaborates with study team to develop project related documents, as needed.
  • Completes monitoring reports and associated communications in compliance with Monitoring Plan and SOPs.
  • Responsible for device accountability at each site visit throughout the study.
  • Reviews and maintains the Investigator Site File/Regulatory Binder and collects documents for Sponsor files.
  • Facilitates submissions to Ethics Committees/Institutional Review Boards (IEC/IRB), and regulatory authorities, as needed.
  • Continuously assesses institutional, regulatory and clinical protocol compliance.
  • Complies with Data Protection (GDPR, HIPAA), Good Clinical Practice (ISO14155), relevant local laws and regulations, SOPs, WIs, clinical protocols, and Manual of Operations.
  • Identifies and escalates non-compliance and project related risks, as needed.
  • Participates in project team meetings, escalates risks and issues, and represents monitoring function as needed.
  • Supports activities related to site audits and/or regulatory inspections.
  • Collaborates with global and cross-functional team members to problem solve, share best-practices and provide input on process improvement initiatives.
  • Other duties as assigned

The Paradise™ Ultrasound Renal Denervation (uRDN) System by ReCor Medical utilizes ultrasound energy delivered by a balloon catheter to target overactive renal nerves, potentially reducing blood pressure and medication dependency through a minimally-invasive procedure.

Company Stage

Series D

Total Funding

$37.9M

Headquarters

Palo Alto, California

Founded

2009

Growth & Insights
Headcount

6 month growth

14%

1 year growth

53%

2 year growth

94%