Healthcare: Clinical Research Physician III/Clinical Research Associate III - Elizabeth, New Jersey

Roles & Responsibilities: 1) Review of draft SAE case narratives and other narratives for events of special interest for understandability, consistency and medical correctness (200 narratives) 2) Review and interpretation of concomitant medication listings as provided from verbatims in case report forms (750 records) a. Assignment of generic drug name (may be provided in listing as country specific brand name) b. Assignment of dosing regimen (may be provided in medical short hand e.g. 1 qod, bid) 3) Clinical Review of patient profiles and data listings to check for completeness, discrepancies and protocol deviations 4) Support clinical data review and resolution of queries 5) Support clinical team activities to review draft statistical outputs for format and completeness Skill Set: Experience in contributing to and reviewing clinical study reports. Demonstrated knowledge of cardiovascular medicine and medications sufficient to accomplish the tasks shown above. MD or non-MD clinical scientist with several (> 5) years experience with cardiovascular trials (heart failure trial experience would be most relevant). Experience with morbidity and mortality trials (M&M trials) valued. Excellent oral and written communication skills. Experience with writing protocols, clinical study reports, or manuscripts. Demonstrated experience reviewing and interpreting complicated clinical data sets: this is a complicated trial with over 700 data tables anticipated. Strong analytical skills- ability to review and understand complex data sets and make recommendations/proposals for resolving data issues. ()