Cordis · 15 hours ago
Senior Clinical Research Associate (Remote)
United States
Full-time
Remote
Senior Level
5+ years expCordis is a global leader in cardiovascular and endovascular technology, dedicated to transforming cardiovascular care. The Senior Clinical Research Associate will support the execution of clinical trials, ensuring adherence to regulations and protocol compliance while interacting with healthcare professionals and project teams.
Health CareHealth DiagnosticsMedical
Responsibilities
Serve as the primary point of contact for assigned sites, providing guidance on protocol requirements, operational workflows, and issue resolution
Supervise study sites and activities to ensure adherence to appropriate industry US and OUS regulations, ICH/GCP, the study Protocol(s), and applicable local regulations
Conduct remote and/or onsite qualification, initiation, interim monitoring, and close‑out visits with minimal oversight
Perform and communicate detailed review of site study documentation (e.g. ICFs, CTAs, budgets), site-reported data, etc. to Study Lead and study sites
Lead or assist with preparation of study documents (study protocol, ICF, CRF, etc.) and study plans
Manage and maintain internal Trial Master Files (TMFs). Potentially develop a standardized eTMF file nomenclature so that all files are consistently named
Assist in organizing Steering Committee events and meetings, along with helping to prepare educational content
Assess site performance, enrollment progress, and protocol compliance; implement corrective and preventive actions (CAPAs) when needed
Prepare dashboards, reports and other internal tracking mechanisms
Collaborate with cross‑functional teams (clinical operations, data management, safety, regulatory) to ensure timely study execution
Work with and/or oversee the CRO and Core Labs to ensure study operations and activities are of high quality
Assist with organization and content preparation for Investigator meetings and Study Coordinator meetings
Ensure proper proactive and timely escalation of site/project related issues and risks to the Study Lead and contribute to mitigation strategies
Assist with internal audit preparation
Support sites in preparing for audits and inspections; participate in sponsor or regulatory authority inspections as needed
Provide coaching, oversight, and co‑monitoring support to any junior CRAs
Contribute to process improvement initiatives, SOP updates, and operational best practices
Qualification
Required
Requires a minimum 5+ years of relevant experience with a Bachelor's degree; or equivalent education and experience; Or 3+ years and a Master's degree; Or a PhD with no previous professional experience
Where required, the role must hold an appropriate degree in the industry (eg. Legal)
Strong work ethics and commitment to serve internal and external clients
Energy, focus, motivation, debate-friendly, and good interpersonal skills
Strong analytical and problem-solving skills with the ability to anticipate site-level risks
Open and honest approach to debates and constant evaluation
Team player, 'can-do' attitude
Ability and desire to develop good working relationships internally and externally
Excellent written and verbal communication and documentation skills
Proficiency in English to enable engagement with global clinicians
Attention to detail and accuracy of output
Enjoys and has a track record of operating independently and with minimal supervision
Skill in project management, managing multiple sites and prioritizing workflow to meet deadlines
Capable of working across multiple time zones including Europe
Proficiency with MS software (Word, Excel, Powerpoint), EDC, CTMS, eTMF
Preferred
At least 3-5 years of experience working in the medical device space in a CRO or Sponsor setting with strong knowledge of conducting studies under ICH/GCP guidelines, FDA regulations and clinical trial operations
Experience working on an IDE clinical study
Experience with cardiovascular clinical studies
A minimum of a Bachelor's degree, preferably in life sciences, nursing, pharmacy or related field
Company
Cordis
Cordis Corporation, a Johnson & Johnson company, has pioneered less invasive treatments for vascular disease.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
unknown2021-03-12Acquired
Leadership Team
Scott Drake
Chief Executive Officer
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