Job DescriptionJob Description

Summary of Duties and Responsibilities:

• Performs conduct procedures in strict compliance to the study protocol, Good Clinical Practice standards, Standard Operating Procedures (SOP’s), QA/QC procedures, OSHA guidelines and other state and local regulations as applicable
• Oversees and monitors the well-being and safety of study participants by active assessment as well as by serving as a visible point of contact at all times
• Facilitates verbal directions from the Principal Investigator (PI) to study participants and/or clinical study staff and ensures appropriate follow-through
• Assists the PI with the review of laboratory data results for both the selection and randomization of study participants and for the monitoring of safety parameters while study conduct is ongoing
• Provides ongoing assessment of the study subject/patient to identify Adverse Events (AEs), ensures proper documentation and reporting of all AEs, including follow up of open AEs when subjects are not in-house, and provides any appropriate clinical care or instructions to subjects, as directed by the PI or as deemed medically necessary by their professional judgment
• Continuously communicates the progress of study conduct to PI, CSM, and members of the clinical study team through various methods of communication
• Immediately notifies the PI, CSM, and members of the clinic management team upon the occurrence or reporting of a Serious Adverse Event (SAE) by a study participant and initiates documentation of the event
• Enforces rules and regulations with study participants and handles participant complaints efficiently and effectively, maintaining participant satisfaction
• Maintains compliant, clear and accurate study charts and documentation of all AEs reported and Concomitant Medication usage throughout the study
• In the absence of the Clinical Study Manager, performs as the floor leader and mentor, assisting research technicians, clinical research nurses, clinical research paramedics, and laboratory technicians as needed on the conduct floor

Company DescriptionSelect Source International (SSI) is an IT, Health Care, and Engineering Services consulting firm that has been in business since 1998. SSI consultants have provided exceptional services that have been appreciated by clients, customers, and users alike at several large Fortune 500 companies, mid-size enterprises, and consulting companies.Company DescriptionSelect Source International (SSI) is an IT, Health Care, and Engineering Services consulting firm that has been in business since 1998. SSI consultants have provided exceptional services that have been appreciated by clients, customers, and users alike at several large Fortune 500 companies, mid-size enterprises, and consulting companies.

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