Senior Clinical Research Associate
Company: ACE Partners Agency
- Location: United States
- Work mode: Remote
- Seniority: Senior
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
Job title: Senior In-House Clinical Research Associate, Interventional Vascular (Remote, US)
About the company
This is a venture-backed interventional vascular company with an FDA-cleared balloon platform, already selling in the US and Europe. They’ve just closed an oversubscribed Series D and completed the first human cases with their next-generation IVL system. Next comes a pivotal trial and expansion into coronary.
They have 6 studies running and 3 more starting in the next few months. The plan is FDA approval, commercial scale and an exit within the next couple of years, the same path taken by the best IVL companies before them.
The team is small and expert. Your work is seen and you’re not a number.
The role
You’ll be the sponsor’s clinical eyes on the CRO: the person who makes sure the data, imaging and safety reporting stand up. The Senior Director calls this role the glue of the clinical team.
You’ll report directly to the Senior Director of Global Clinical Affairs, with no layers in between.
What you’ll own
- Oversight of CRO monitoring: reviewing monitoring reports, site data and imaging
- Centralised data review and remote monitoring alongside clinical data management
- Tracking and timely reporting of AEs, SAEs and UADEs
- Investigational device accountability and clinical study supplies
- eTMF maintenance, IRB/EC submissions, annual reports and FDA inspection readiness
- Study start-up: feasibility, site selection, ICFs, CRFs and EDC guidelines
What they’re looking for
- Cath lab background (RN, RT or similar) followed by field clinical or CRA work in the industry
- Peripheral AND coronary vascular trial experience, which is critical
- Sponsor or CRO CRA experience on IDE device trials
- Strong working knowledge of GCP, ICH and FDA device regulations
- Clinical judgement: you can read a case, question the data and spot a safety signal
What’s in it for you
- $160k-$170k base
- Bonus and pay reviews twice a year (July and December)
- Promotion reviews twice a year
- Fully remote anywhere in the US, mostly desk-based with minimal travel
- A front-row seat for pivotal trials, a coronary launch and a potential exit
Interested?
Apply here or message me directly. All conversations are confidential.
