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Director

Department:
Clinical Research Organization

Responsibilities:

Oversees all clinical research activities and regulatory affairs for the division
Manages the planning, implementation and monitoring of all ongoing studies
Accountable and point of contact for all study-related conduct issues
Ensures all studies comply with GCP/ICH, FDA, local, other regulations and company Standard Operating Procedures
Oversees clinical project teams and ensures on-time, on-budget performance
Reviews and develops study proposals, budgets, protocols, case report forms and study forms
Participates in investigator’s meetings and all meetings with clients
Reviews and approves monitoring trip reports, SAE reports, invoices, project management reports and contracts
Monitors and directs in-house and regional personnel to execute and monitor protocols and successful completion of projects
Manages timelines, flow of reports and information between the company, sponsor, other project team members and all other agencies
Proactively identify potential problems and develops recommendations of resolution
Institutes and enforces change for improved efficiencies internally
Supervises all central staff, senior project team leaders and clinical research associates
Manages projects and monitor sites as necessary

Qualifications:

Department:
Clinical Research Organization

Responsibilities:

Serves as the main contact person for the sponsor and the rest of the project team
Organizes start-up meetings and schedules regular meetings with the project team and sponsor
Trains project team regarding protocol and study procedures
Proactively works with project team and sponsor in identifying and resolving issues
Tracks study enrollment status and provides weekly updates to Sponsor
Ensures timelines are being met

Qualifications:

Department:
Clinical Research Organization

Responsibilities:

Monitors clinical trials under GCP guidelines from initiation through interim and close out visits, including drug accountability and reconciliation.
Reviews protocols, patient informed consent and case report forms to ensure compliance with FDA regulations
Ensures qualifications and expectations of investigators, sub-investigators and study coordinators with respect to the protocol
Approves procedures and facilities for storage of the test articles and maintenance of accountability
Reviews study files for completeness (i.e. IRB approvals, signed consent forms, correspondence, reports of adverse experiences to IRB and RTL)
Reviews CRFs and source documentation to ensure protocol compliance

Qualifications:

Department:
Clinical Research Organization

Responsibilities:

In addition to the duties of a Clinical Research Associate:

Contact person for the study sponsor and others involved in the study
Responsible for assuring all administrative and study requirements are met on time
Ensures qualifications and expectations of investigators, sub-investigators and study coordinators with respect to the protocol
Approves procedures and facilities for storage of the test articles and maintenance of accountability
Reviews study files for completeness (i.e. IRB approvals, signed consent forms, correspondence, reports of adverse experiences to IRB and RTL)
Reviews CRFs and source documentation to ensure protocol compliance
Supervises all Clinical Research Associates

Qualifications:

Department:
Clinical Research Organization

Responsibilities:

Collects all regulatory documents from all sites and submits to the IRB
Ensures all IRB approvals are in place before study enrollment and monitors progress of studies
Coordinates SAE Reporting
Maintains the Investigator database
Create and track questionnaires/surveys during the process of site selection

Qualifications:

Department:
Clinical Research Organization

Responsibilities:

Assists the regulatory coordinator in performing regulatory function with respect to FDA guidelines for conducting clinical trials
Assists the project manager with tracking and monitoring subject enrollment
Assists the director with creating spreadsheets and forms
Acts as a department liaison with field staff and sponsor
Prepare memos, study reports, document tracking forms, essential documents binders and other reports as necessary
Track and maintain case report forms
Coordinate teleconference calls
Perform other administrative duties as assigned

Qualifications:

Department:
Clinical Research Organization

Responsibilities:

Qualifications: