PS Clinical Site Monitor

Job Summary

This position will provide project management and clinical monitoring support for Investigator-Initiated Trials (IITs) coordinated by the Huntsman Cancer Institute (HCI) Research Compliance Office (RCO) from trial start-up through trial closeout. The incumbent will act as a liaison between clinical sites, the Research Compliance Office, sponsors/funding agencies and the Principal Investigators to ensure that clinical trials are conducted in compliance with the protocol, and applicable institutional and regulatory guidelines. As a member in the Research Compliance Office department, the candidate will also be responsible for quality assurance oversight of clinical trials via monitoring and auditing trials and reporting study progress to the Data Safety Monitoring Committee (DSMC). This is a hybrid position and requires onsite work to be performed at Huntsman Cancer Institute, where some of the work may be done remotely.

Responsibilities

Essential Functions:

1. Performs on-site and remote monitoring activities of clinical research studies.
2. Oversee, coordinate and conduct monitoring of clinical investigations to ensure compliance with University, Food and Drug Administration (FDA), Office of Human Research Protection (OHRP), Good Clinical Practice (GCP), state and federal guidelines.
3. Analyze and document monitoring processes for all activities in the conduct of the clinical investigation, and recommend improvements to operating policies and procedures for compliance review. Monitor and follow up on required documentation related to audit processes.
4. Develop and maintain site feasibility packets, multisite study procedural manuals, and other multisite process documents.
5. Prepare clinical sites for study start-up by conducting site initiation visits.
6. Analyze and evaluate data gathered during research. Identify data discrepancies and missing data in source records or CRF's.
7. Recognize protocol deviations and other study related issues and work to resolve and/or make appropriate recommendations for correction and full resolution.
8. Perform dual review of eligibility to verify that potential clinical trial participants meet protocol specific eligibility criteria and provided informed consent according to federal and IRB regulatory guidelines.
9. Monitor adverse events for seriousness and facilitate the AE/SAE reporting process to ensure that all adverse events are reported to the study supporter and all participating site IRB's.
10. Process new study subject registrations prior to enrollment.
11. Communicate with sites regarding the determinations made on behalf of the DSMC.
12. Oversees the maintenance and organization of project documentation and records.
13. Act as a liaison between the external clinical site(s), HCI parties (PI, regulatory team, study team, etc.) study sponsors and/or regulatory agencies and the research compliance office to resolve any issues that may arise throughout the course of the study.
14. Provides guidance and training to research faculty and staff pertaining to complex and highly specialized rules and regulations including complex protocol, multisite trials and IND/IDE issues.
15. Assists in the development of policies, procedures and process improvements for departmental implementation and guidance for external associates.
16. Other responsibilities may include but are not limited to; updating and revision of SOPs, training and orientation of study staff, organization of coordinator/investigator meetings.
17. Perform other duties as assigned by management.