DaVita Inc.
Clinical Trial Project Manager
DaVita Inc. - Boston, Massachusetts, us, 02298
Work at DaVita Inc.
Overview
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Overview
GENERAL SUMMARY/ OVERVIEW STATEMENT:
Like the look of this opportunity Make sure to apply fast, as a high volume of applications is expected Scroll down to read the complete job description. The Program for the Coordination and Oversight of Research Protocols (PCORP) within the MGH Cancer Center Protocol Office specializes in the central coordination, monitoring and regulatory oversight of Investigator-initiated, multi-center clinical trials. PCORP is seeking candidates experienced in clinical trial coordination and implementation to provide managerial, operational and supervisory oversight for a team of research coordinators/monitors and their respective research trials. The Clinical Research Project Manager will independently direct a team of research staff to coordinate, monitor and advance a portfolio of therapeutic oncology trials from concept through completion. Project Manager responsibilities include direct management of individual trials in addition to the hiring, training, and first-line supervision a team of research staff and the day-to-day operations other their research portfolios. The Project Manager has oversight responsibility of the team's timeline management, clinical quality assessment and trial operations integrity and for ensuring Sponsor-Investigator and Site Investigator compliance with Federal and local regulatory requirements. The Clinical Research Manager provides input into the assessment of program procedures and staff management, while maintaining a working knowledge of all aspects of clinical research management.
PRINCIPAL DUTIES AND RESPONSIBILITIES: Manager responsibilities include: Trial and portfolio coordination Coordination, regulatory maintenance, monitoring and timeline management of several multi-center clinical trials within the Cancer Center Ongoing evaluation and verification of protocol procedures, regulatory and data compliance and alignment with federal and local regulations across all participating sites Act as central communications liaison for all clinical trial collaborators Work directly with entities within and outside the organization, including Investigators, funding sponsors, collaborators and vendorsto establish workflow, monitor process and identify and resolve issues Identify variance across participating sites' Standard Operating Procedures and developing processes to ensure compliance Fulfill routine and expedited reporting requirements to all funding sponsors, monitoring boards, regulatory boards or other governing agencies (e.g. FDA, IRB, DSMB, etc) Occasional domestic travel required (
Like the look of this opportunity Make sure to apply fast, as a high volume of applications is expected Scroll down to read the complete job description. The Program for the Coordination and Oversight of Research Protocols (PCORP) within the MGH Cancer Center Protocol Office specializes in the central coordination, monitoring and regulatory oversight of Investigator-initiated, multi-center clinical trials. PCORP is seeking candidates experienced in clinical trial coordination and implementation to provide managerial, operational and supervisory oversight for a team of research coordinators/monitors and their respective research trials. The Clinical Research Project Manager will independently direct a team of research staff to coordinate, monitor and advance a portfolio of therapeutic oncology trials from concept through completion. Project Manager responsibilities include direct management of individual trials in addition to the hiring, training, and first-line supervision a team of research staff and the day-to-day operations other their research portfolios. The Project Manager has oversight responsibility of the team's timeline management, clinical quality assessment and trial operations integrity and for ensuring Sponsor-Investigator and Site Investigator compliance with Federal and local regulatory requirements. The Clinical Research Manager provides input into the assessment of program procedures and staff management, while maintaining a working knowledge of all aspects of clinical research management.
PRINCIPAL DUTIES AND RESPONSIBILITIES: Manager responsibilities include: Trial and portfolio coordination Coordination, regulatory maintenance, monitoring and timeline management of several multi-center clinical trials within the Cancer Center Ongoing evaluation and verification of protocol procedures, regulatory and data compliance and alignment with federal and local regulations across all participating sites Act as central communications liaison for all clinical trial collaborators Work directly with entities within and outside the organization, including Investigators, funding sponsors, collaborators and vendorsto establish workflow, monitor process and identify and resolve issues Identify variance across participating sites' Standard Operating Procedures and developing processes to ensure compliance Fulfill routine and expedited reporting requirements to all funding sponsors, monitoring boards, regulatory boards or other governing agencies (e.g. FDA, IRB, DSMB, etc) Occasional domestic travel required (