Duties include but are not limited to:

·       Practice and adhere to the “Code of Conduct” philosophy and “Mission and Value Statement”

·       During your employment with HRI you will be routinely assigned training requirements. You are expected to complete any training assignments by the due date.

·       Performs routine operational activities for multiple research protocols

·       Liaise between site research personnel, industry sponsors, and Supervisor

·       Collaborates closely with various site departments/teams, including finance, relevant hospital administrative representatives, and the local IRB, if applicable

·       Coordinates schedule of assessments from initial submission of feasibility until study closeout

·       Reviews the study design and inclusion/exclusion criteria with physician and patient

·       Ensures the protection of study patients by verifying informed consent procedures and adhering to protocol requirements

·       Ensures the integrity of the data submitted on Case Report Forms or other data collection tools by careful source document review; monitors data for missing or implausible data

·       Creates study specific tools for source documentation when not provided by sponsor

·       Collects, completes, and enters data into study specific case report forms or electronic data capture systems

·       Generates and tracks drug shipments, device shipments, and supplies as needed

·       Ensures timely and accurate data completion

·       Tracks and reports adverse events, serious adverse events, protocol waivers, deviations, and violations

·       Communicates all protocol-related issues to appropriate study personnel or manager

·       Attends study specific on-site meetings, investigator meetings, conference calls and monthly CRC meetings, as required

·       Reviews and responds to any monitoring and auditing findings