Part Time Sub Investigator

Would you like to work for a premier provider of innovative solutions in drug discovery and development?  MDS Pharma Services has an exciting opportunity as a Part Time Sub Investigator at our Tempe, AZ location.  
 
Purpose:

Conduct clinical studies according to study protocols, review safety data and monitor the safety of study participants enrolled into clinical trial protocols.

Essential Functions:

Pre-study

-Oversee the informed consent process of study subjects.
-Perform screening examinations
-Review subject screening data, including subject medical histories, ECGs, radiographic studies, laboratory studies, labwork and any other ancillary tests required per study protocol.
-Interact with client in-person (on-site) or via written, electronic or telephone correspondence to address any screening related questions.
-Client interaction of safety concerns on-site visits, screening review
-Review of subjects eligibility based upon protocol inclusion and exclusion criteria
-Approve subjects for inclusion on study.

Review, initial and date all safety related data in a timely manner to include laboratory studies, ECGs and all other safety data as dictated by the study protocol.
-Safety monitoring – Monitor, review, and track adverse events and serious adverse events.  Provide treatment as needed.

Post-study

-Safety monitoring - perform end-of-study physical examinations and provide follow-up for any ongoing adverse events
-Assist P.I. in review of Case Report Forms
-Assist P.I. with on-site client review of case report form

-Coordinate with nursing staff to ensure proper medical coverage for clinical studies
-Responsible for adverse drug assessments, evaluations, and documentation under guidance of PI
-As needed, assist with training of clinic associates on ECG procedures, manual vitals procedures and assessment skills related to reporting adverse events
-Assist in the design of study and time/event schedules involving special medical procedures
-Order specialized equipment for special clinical studies.
 

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