Clinical Trials Coordinator

* Responsible for all portions of study initiation which includes
-coordinate with lab in development of new tests
-coordinate with warehouse for necessary study supplies
-coordinate with MIS department for study specifications
-coordinate with Data Entry & Set-up for study specifications
-coordinate with Sponsors & various monitoring organizations
-write Laboratory Investigator’s Training Manual and Laboratory Protocols.
* Attend investigator meetings & train sites on how to collect laboratory samples
* Do professional presentations at Investigator meetings.
* Manage pharmokinetic samples for studies
* Responsible for on-going study management which includes:
-monitoring sites & identifying any site problems to sponsor
-on-going training on specimen collection & protocol specifications
-participating in conference calls or meetings requested by sponsor
-preparing specialized reports for sponsor
-maintaining & updating study file
* Coordinate with the QA/QC officers for correct study specifications
* Update TLS database with all correct study parameters & update
* Serve as the “Global Study Director”: when performing global studies* Take resupply orders, refax reports, take changes in patient information from sites
* Review reports & release them to the sites
* Help with cost estimates for studies
Assist Clinical Trials customer service, data entry, & set up when needed
REQUIREMENTS
* Must have clinical lab experience
* B.S. degree in Medical Technology or equivalent certification and job experience in a related field. MLT (ASCP), MT (AAB) and HHS certifications preferred but BS in the sciences acceptable
* 1 year customer/client contact experience; familiarity with clinical trials services
* Strong oral & written communication skills; strong organization ability & problem solving skills; professional manner with clients; must work well under pressure; flexibility
* Saturday rotation required; overtime as needed; travel to investigator meetings