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Clinical Research Program Coordinator

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Company: Md Anderson

Location: Houston, TX

Date Posted: March 22, 2014

Source: MD Anderson

Job Location: Houston, TX

Salary Minimum 49,600.00
Salary Midpoint 62,000.00
Salary Maximum 74,400.00

Summary
Responsible for submission, revision, and renewal of the Department of Gynecologic Oncology Industry Sponsored Program protocols according to institutional and federal guidelines. Acts as the department expert/resource for all private industry program matters related to protocol submission and documentation.
Key Functions
Function #1: Protocol Processing and Regulatory Management
Responsible for preparing all private industry program studies for submissions, amendments, monitoring and annual reviews according to institutional guidelines using Protocol Document On-Line (PDOL), eResearch and/or other applicable software on computer. Knowledgeable regarding pharmaceutical protocol submission process, formatting requirements, deadlines, and regulatory issues. Responsible for ensuring that all regulatory and institutional requirements are met before study activation.
Revises active private industry protocols as directed or required and composes all necessary correspondence accompanying the revisions. Routes new submissions, amendments via electronic ...

Job Location: Houston, TX

Salary Minimum 49,600.00
Salary Midpoint 62,000.00
Salary Maximum 74,400.00

Summary
Responsible for submission, revision, and renewal of the Department of Gynecologic Oncology Industry Sponsored Program protocols according to institutional and federal guidelines. Acts as the department expert/resource for all private industry program matters related to protocol submission and documentation.
Key Functions
Function #1: Protocol Processing and Regulatory Management
Responsible for preparing all private industry program studies for submissions, amendments, monitoring and annual reviews according to institutional guidelines using Protocol Document On-Line (PDOL), eResearch and/or other applicable software on computer. Knowledgeable regarding pharmaceutical protocol submission process, formatting requirements, deadlines, and regulatory issues. Responsible for ensuring that all regulatory and institutional requirements are met before study activation.
Revises active private industry protocols as directed or required and composes all necessary correspondence accompanying the revisions. Routes new submissions, amendments via electronic format to the appropriate office and communicates with all involved to see that the revisions are reviewed, approved, and activated in a timely manner. Develops patient care methodology for protocols, including establishing criteria for patient participation and working with the research nursing staff to determine eligibility criteria for abstracts and informed consents. Interfaces with the Office of Protocol Research and external regulatory committees and offices. Interacts with private industry sponsors and their Clinical Research Organization (CRO) as the primary point of contact for monitoring and coordinates program audits. Acts as a departmental resource for matters related to private industry program protocol issues. Processes protocol documents for grant submissions.
Function #2: Communication
Responsible for the creation and distribution of all correspondence (announcements, documents, and other protocol-related correspondence) to institutional departments and outside organizations as required or requested. Retrieves and responds to electronic mail on a timely basis.
Function #3: Internal Protocol Database
Consults with the department Clinical Research Program Coordinator and Clinical Protocol Manager to determine the placement of each study in the Internal Protocol Database and ensures that all forms necessary for internal review are completed prior to presentation to the Research Administration Core Committee (RACC).
Addresses continuing review and/or IRB/PBHSR contingencies or forwards to the study manager or Principal Investigator for completion. Forwards copies of IRB approval memos to private industry contact and their CROs as needed.
Function #4: Other Duties as Assigned:
Non-Essential Functions
May assist other staff members in completing work assignments if necessitated by work load/employee absence, etc.

Job ID: 3663BR

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