Clinical Research Associate San Antonio, TX

 

Chronos Consulting's (www.chronosconsulting.com) client is a leading developer and manufacturer of non-invasive diagnostic medical devices.
 
This role is home office based with up to 70% travel in TX and southeast US.
 
Roles & Responsibilities:
•Provide clinical research project management and study site monitoring which shall include, among others:
a.Site feasibility
b.Site initiation and training of personnel at sites that are participating in trial, routine monitoring visits and close out visits for each study site assigned
c. Manage scope of projects 
d.- Write monitoring plans
e.  Monitoring sites; collecting data, assuring complete ICFs and CRFs and adherence to protocol, compare CRF entries to source documents, identifying adverse events. Facilitate decision-making and documenting regarding accepted deviations. Prepare reports after each visit.
f.- Review monitoring reports when site monitoring by other CRA
g.- Provide study metrics at specified intervals
h.- Review and document review of investigators qualifications
i.- Travel to and from each site
j.- Provide monitoring reports for review for each monitoring visit within 10 business days of monitoring visit completion
k.- Remote monitoring of EDC, Checking completeness of data and requesting missing information.
l.- Manage identified sites and periodic communication with sites
m.- Other project activities
n.Assuring stock of kits for tests at all sites 
 
Qualifications:
•B. Sc. or higher in life sciences  
•clinical studies experience with medical devices required
•Preferable formal education and/or training in FDA and EMEA regulation, CRA, cGMP, GLP
•Familiar with laws governing the conduct of clinical studies 
•Excellent oral and written English 
•Excellent communication and interpersonal skills
•Highly organized and detail oriented with superb project management skills
 
apply to This email address is being protected from spambots. You need JavaScript enabled to view it.