Job Responsibilities

• Aligns w/ key stakeholders both internal & external to manage all study coordination & conduct activities for multisite investigator-initiated studies, in accordance w/relevant regulations, Standard Operating Procedures (SOP), & study specific procedures.
• Serves as the primary contact for external subsites on all project related operational matters.
• Collaborates with WCM Principal Investigator (PI) on project design and development of study protocol and informed consent form (ICF).
• Completes all WCM regulatory submissions including Protocol Review and Monitoring Committee (PRMC), Institutional Review Board (IRB), Data Safety Monitoring Committee (DSMC), and other regulatory agencies as required.
• Coordinates with Clinical Research Subsite Navigators to ensure timely dissemination of new and revised project documents to participating subsites.
• Creates the electronic data capture (EDC) system in collaboration with the developers on protocol-specific database design. Ensures the user interface is intuitive for study team use.
• Generates subsite data completion metrics for distribution to subsite PIs and study teams.
• Develops and implements a project-specific monitoring plan. Performs remote monitoring visits to review data timeliness and accuracy. Issues queries for missing data elements or those requiring follow-up.
• Ensures timely resolution of pending data entry and queries.
• Plans subsite Site Initiation Visits (SIV). Develops presentations, training, and educational materials to ensure successful subsite start up. Provides ongoing training and subsite study team support throughout the course of the project.
• Prepares and presents study metrics, progress, and long-term goals at Steering Committee meetings. Leads project-specific study coordinator meetings.
• Provides ongoing updates and reporting to subsite study teams, WCM PI and internal collaborators. Streamlines and facilitates communications with subsites.
• Performs other related duties as assigned.

Education

Bachelor's Degree

Experience

Approximately 3 or more years of related research experience in clinical trial management.

Knowledge, Skills and Abilities

Knowledge of FDA regulations, IRB requirements, Good Clinical Practice, and clinical research databases.

Job Responsibilities

• Aligns w/ key stakeholders both internal & external to manage all study coordination & conduct activities for multisite investigator-initiated studies, in accordance w/relevant regulations, Standard Operating Procedures (SOP), & study specific procedures.
• Serves as the primary contact for external subsites on all project related operational matters.
• Collaborates with WCM Principal Investigator (PI) on project design and development of study protocol and informed consent form (ICF).
• Completes all WCM regulatory submissions including Protocol Review and Monitoring Committee (PRMC), Institutional Review Board (IRB), Data Safety Monitoring Committee (DSMC), and other regulatory agencies as required.
• Coordinates with Clinical Research Subsite Navigators to ensure timely dissemination of new and revised project documents to participating subsites.
• Creates the electronic data capture (EDC) system in collaboration with the developers on protocol-specific database design. Ensures the user interface is intuitive for study team use.
• Generates subsite data completion metrics for distribution to subsite PIs and study teams.
• Develops and implements a project-specific monitoring plan. Performs remote monitoring visits to review data timeliness and accuracy. Issues queries for missing data elements or those requiring follow-up.
• Ensures timely resolution of pending data entry and queries.
• Plans subsite Site Initiation Visits (SIV). Develops presentations, training, and educational materials to ensure successful subsite start up. Provides ongoing training and subsite study team support throughout the course of the project.
• Prepares and presents study metrics, progress, and long-term goals at Steering Committee meetings. Leads project-specific study coordinator meetings.
• Provides ongoing updates and reporting to subsite study teams, WCM PI and internal collaborators. Streamlines and facilitates communications with subsites.
• Performs other related duties as assigned.

Education

Bachelor's Degree

Experience

Approximately 3 or more years of related research experience in clinical trial management.

Knowledge, Skills and Abilities

Knowledge of FDA regulations, IRB requirements, Good Clinical Practice, and clinical research databases.