Clinical Research Associate I

Job Summary :

This role will act as the project manager for a large multi-site clinical trial where the clinical site is also the coordination center for the clinical trial. Duties include but are not limited to : coordinate all aspects of the clinical trial at the Sponsor Level including but not

limited to : procuring study drug, site selection and management, vendor selection, consent form development, study document creation, study and data monitoring oversight, SAE and protocol deviation reporting and management, communication and periodic reporting to regulatory agencies and financial sponsors, secure and track all regulatory and financial documents from all sites; critical role in maintaining separation as Site and Coordination Center Candidate must have ability and desire to schedule meetings, write documents, review documents, design CRFs, answer site questions, identify and work with vendors (drug supply, labs, central pharmacy), work with IRBs, consult with biostatisticians, develop study manuals for sites, develop study manual for Coordination Center, develop SAE workflow, develop protocol violation work flow, track study metrics, prepare Investigators Meeting and necessary trainings, develop enrollment plan, prepare reports to DSMB and set up DSMB meetings, review site monitoring reports, and conduct study team meetings. Candidate with nursing degree would engage in acquisition of blood and urine samples which would be processed, stored, and catalogued for biomarker studies. Candidates with laboratory bench experience would engage in processing of blood and urine samples which would be stored and

catalogued for biomarker studies.

Minimum Qualifications :

A Bachelors Degree of Science in an related field and two years of related experianceor equivalent combination of education and experience.

Preferred Qualifications :

Master's Degree or Doctorate Degree in a related field.

Work Days : Monday-Friday (Days)

Message to Applicants :

Salary Range-$60,406-$65,000

RecruitmentOffice : Human Resources