Job Abstract

Summary

The Coordinator, Clinical Studies – Regulatory - ensures regulatory compliance for the Department of Genitourinary Medical Oncology clinical trials, assists with the institutional and federal approval procedures for research laboratory and clinical trials and provides education relevant to regulatory matters to the research staff.

Key Functions

Regulatory Compliance:

Assembly of regulatory documents required per local and FDA regulation, departmental and institutional standard operating procedures (SOPs) and processes for clinical trial operations (activation, amendments, etc.).

Timely submission of required clinical trial regulatory documents as above (IND related documents for Compliance Office and oversight of the FDA approval process, etc.)

Communicates with applicable sponsors regarding clinical trial regulatory document submissions.

Creates, updates, and oversees maintenance of current regulatory files for all GU protocols according to departmental SOPs.

Collaborates with institutional departments and/or outside institutions to maintain appropriate regulatory documentation.

Participates in routine monitoring visits and provides sufficient, appropriate, and timely responses to sponsor or auditor regulatory queries.

Provides support to the Protocol Teams in preparing for inspections by regulatory agencies.

Performs routine Quality Assurance of regulatory files for assigned clinical trials prior to monitoring, audit, or inspection visits.

Assists in development and maintenance of a regulatory document control system.

Participates in developing departmental processes for organization, record, and coordination of regulatory-related operations. Conduct simple analyses of processes and identify and resolve problems and quality issues.

Tracks changes and updates in regulatory laws/guidelines as they occur. Discusses and communicate changes to appropriate team members, including management. Assists in the coordination and implementation of changes to department process as necessary.

Prepares for and attends study start-up meetings for assigned trials or as back-up.

Maintains up to date knowledge of public website updates and maintenance, including but not limited to FDA clinical trials.gov website and the NCI Clinical Trials Reporting Program (CTRP) website. Communicates with the Institutional team on behalf of the PI and Protocol Team as needed.

Assists in the organization and development of the GU multicenter regulatory infrastructure for collection, tracking, sharing, and maintenance of relevant regulatory documentation for collaborating institutions and investigators.

Participates in PI meetings in order to communicate key regulatory information to the protocol team.

Protocol Submissions:

Prepares and reviews clinical trial documents for submission of new and amended or modified documents for the Institutional Review Board (IRB), the National Cancer Institute (NCI), the Food and Drug Administration (FDA), sponsor or supporters and other approving entities.

Creates and edits Informed Consent Documents for new and amended or modified clinical trial documents.

Provides Quality Assurance to ensure consistency between clinical trial and related documents and that the documents are written in accordance with institutional and federal guidelines governing clinical research and lab protocols.

Interacts professionally by e-mail, phone, and face-to-face with pharmaceutical company representatives, governmental agents, institutional physicians and staff, and others.

Maintains up to date knowledge of departmental and institutional databases for execution of clinical trial workflow such as ePRTCL, CORe, Prometheus, ClinicalTrials.gov, and others as indicated.

Maintains knowledge of pharmaceutical databases for execution of clinical trial workflow and regulatory communication such as the Shared Investigator Platform, and external IRB interfaces.

Budgeting and Research Accounting:

Maintains up to date basic knowledge of the protocol budget creation and budget/payment schedule negotiations.

Maintains knowledge of the protocol Cost Determination revision, finalization, and submission as it affects the protocol and informed consent documents.

Completes forms (as specified) for protocol, contract, and budget approval that affect clinical trial operations (activation, amendments, etc.).

Maintains up to date knowledge of patient reimbursement processing and forms required for the IRB protocol submission process.

Maintains up to date basic knowledge of the Institutional contract/financial systems and departmental process, and communicates with co-workers with full access of these systems.

Maintains up to date basic knowledge of the departmental process for invoice payment and reconciliation.

Maintains up to date basic knowledge of the terminology related to No Cost Extension requests used when clinical trials exceed the original contract timeline.

Education:

· Participates in the orientation process of new Clinical Research Group employees as well as ongoing training of current staff regarding regulatory matters.

· Participates as a speaker in departmental in-services and trainings.

· Attends appropriate departmental meetings and institutional continuing education programs.

· Shares information and develops and/or designates educational presentations for the monthly Clinical Research Group (CRG) meetings and Data Coordinator/Research Nurse staff meetings, as approved by supervisor.

· Prepares updates on laws/regulations for distribution to CRG members.

· Maintains working and teaching knowledge of current Code of Federal Regulation and Good Clinical Practice guidelines as well as a comprehensive understanding of the research trial process, including but not limited to basic eligibility and disease processes.

· Maintains a working knowledge of departmental clinical trial workflow in order to communicate with the team for proper execution of trial procedures.