Not provided by employer
Founded in 2001, cvrx is a leader in innovative technologies that address the unmet needs in cardiovascular diseases with safe and effective therapiesWe have developed truly groundbreaking technology that is improving patient lives across the globeCvrx is comprised of dedicated and talented industry leaders working together to make a mark within the medical device industry.
Our team works earnestly to fulfill the mission of serving the under-met need of heart failure patients and providing solutions that lead to longer, healthier lives.
It is an exciting time at cvrx and we are currently looking for talented individuals to join us in this journey!
The clinical research associate ii (cra ii) performs the day-to-day operations associated with the execution of clinical trials and is responsible for direct contact with assigned clinical investigative sitesThe cra ii will coordinate site activities from site start-up to site closure as neededThe cra ii will ensure the overall quality of the clinical sites by reviewing study data and managing site adherence to the protocol, gcp, all applicable regulations.
Develops and maintains successful working relationships with study sites and cvrx field staff
Assists in the preparation of study materials and training of investigators, center staff, and cvrx field staff.
Processes payments to sites, vendors, and consultants.
Supports clinical centers in the execution of site irb or ethics committee submissions.
Responsible for the collection, tracking, and maintaining required regulatory documents from clinical centers.
Responsible for shipment of study-related materials.
Coordinates and conducts monitoring (as directed by the monitoring plan) at participating centers to ensure compliance with the protocol, regulations, and the timely receipt of accurate data / other required study documents.
Source verifies clinical data/information and oversees data correction to match the source.
Reviews monitoring reports.
Manages device accountability at the site.
Reviews clinical data/information and oversees data correction.
Provides input to study budgets and project plans.
Takes initiative to assist in the oversight of activities conducted by contract research organizations (cro`s).
Reviews center activation documentation.
Assists in training of new clinical research associates.
Completes special projects and performs job-related duties as assigned.
Bachelor`s degree or at least 4 years of relevant clinical research experience.
2-4 years experience directly supporting clinical research or similar experience in a medical/scientific area.
Knowledge of medical terminology.
Experience with gcp`s and regulatory compliance guidelines for clinical trials.
High attention to detail and accuracy.
Able to manage multiple tasks.
Normal office conditions.
Must be able to sit/stand/walk 8 hours per day.
Position requires up to 40% travel.
Must be fully vaccinated against the covid-19 virus and willing to comply with pre-employment screening, including but not limited to reference verification and background check.
Posted 2 days ago