Job Description
**PURPOSE AND SCOPE:**
Responsible for the collection, accuracy and validity of clinical research data for assigned clinical studies in accordance with the study protocol and timelines. Performs a variety of complex activities to appropriately compile, document and analyze clinical research data, using the subject’s medical record as source. Negotiates differing priorities with multiple players whilst balancing a multiple number of tasks and timelines under a complex network of rules and regulations. Ensures research studies are conducted according to established company policies and procedures as well as all applicable State and Federal regulations, specifically Good Clinical Practice (GCP, ICH, and FDA guidelines. Practices cost containment strategies while ensuring appropriate enrollment of subjects in studies.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
+ Assists with the determination of the guidelines for the collection of clinical data and coordinates and...
Responsible for the collection, accuracy and validity of clinical research data for assigned clinical studies in accordance with the study protocol and timelines. Performs a variety of complex activities to appropriately compile, document and analyze clinical research data, using the subject’s medical record as source. Negotiates differing priorities with multiple players whilst balancing a multiple number of tasks and timelines under a complex network of rules and regulations. Ensures research studies are conducted according to established company policies and procedures as well as all applicable State and Federal regulations, specifically Good Clinical Practice (GCP, ICH, and FDA guidelines. Practices cost containment strategies while ensuring appropriate enrollment of subjects in studies.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
+ Assists with the determination of the guidelines for the collection of clinical data and coordinates and...