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
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