Comrise
6 Months Contract
MUST HAVE CARDIAC RESEARCH EXPERIENCE
· 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