MD Anderson Cancer Center Coordinator, Clinical Research Program in Houston, Texas
The University of Texas MD Anderson Cancer Center in Houston is one of the world's most respected centers focused on cancer patient care, research, education and prevention. It was named the nation's No. 1 hospital for cancer care in U.S. News & World Report's 2018 rankings. It is one of the nation's original three comprehensive cancer centers designated by the National Cancer Institute.
The primary purpose of the Clinical Research Program Coordinator is to manage the regulatory portfolio for The Division of Radiation Oncology's MD Anderson Research Program. This individual will provide divisional faculty and research staff with regulatory support for conducting research and ensure strict adherence to the policies and procedures of the institution. This individual will interact with stakeholders both internal and external to the organization and should possess excellent communication skills to increase efficiency, collaboration, and effectiveness within the program.
Plan, develop, and organize the regulatory aspect of the Division of Radiation Oncology's.
Manage Divisional Research projects and collaborate closely with key stakeholders in activating clinical trials within MD Anderson.
Act as primary contact/liaison for the regulatory processing of research projects within the Division of Radiation Oncology .
Provide regulatory oversight for the overall effective operations of the Division's research protocols, which includes collaboration with the principal investigator or study sponsor to resolve regulatory issues. Develop, implement, or revise processes to improve quality and efficiency.
Understand and apply the requirements, recommendations and guidance related to the conduct of multicenter clinical trials as delineated in the HRPP Toolkit, MDACC institutional policies, ICH-GCP, and FDA guidelines .
Provide routine communication and updates regarding the progress of Division of Radiation Oncology's projects to key stakeholders. Identify and problem solve any delays and/or opportunities to increase efficiency
Monitor the progress of regulatory workflows . Accountable for tracking and improving the overall activation timeline metrics for Division of Radiation Oncology's protocols.
Coordinate with Research Team to ensure all regulatory requirements are met for the addition of new sites to Division of Radiation Oncology clinical trials.
Receive protocol modification requests from various stakeholders to be considered by the Principal Investigator (PI). Work with PI to determine if proposed changes would alter the overall study objectives and design. Track and follow up until resolved.
Prepare protocol modifications and communicate with stakeholders for feedback prior to submission. Submit to the IRB and monitor the IRB approval progress.
Ensure protocol modifications for assigned studies are disseminated to all key stakeholders immediately following IRB approval .
Prepare and complete regulatory reports or forms as needed for assigned Division of Radiation Oncology's research projects to share with sponsors, agencies, and/or other external entities .
Assist in reviewing, verifying, and tracking project milestones as outlined in the project's executed research agreement. Support the verification and tracking of study invoices, for the release of funds to participating research sites.
Support the Program Manager in tracking the funds flow for assigned studies. Coordinate purchase order payment submissions, facilitate communications with MDACC Accounts Payable and with external stakeholders . Process and provide updates for study-specific items such as accrual invoices, laboratory supplies, etc.
Provide regulatory support to all Radiation Oncology faculty and staff regarding assigned projects .
Coordinate and distribute lab kits/supplies to participating Network sites on assigned projects.
Manage regulatory file for assigned research projects.
KEY RADIATION ONCOLOGY RESEARCH FUNCTIONS
Coordination of regulatory correspondence on research projects.
Communicate effectively, verbally and in writing, as needed or as requested by the principal investigator of the study, with internal reviewers (IRB, etc), external agencies (pharmaceutical companies and /or government sponsors), or other pertinent stakeholders throughout the organization.
Complete regulatory forms in accordance with institutional, state, and federal agencies.
Understand and adhere to the policies and procedures related to conduct of clinical trials as delineated in the department training manual and presented at weekly training meetings.
Direct regulatory support to the Division's research protocols.
Process study document translations and/ or obtain appropriate licensure for data collection instruments/tools for assigned projects in accordance with Institutional policy/ procedure.
Review protocol documents including abstracts, text and informed consent for relevant information.
Assist in modifying consents, protocols, surveys or other study-related documents as instructed; submit to IRB.
Assist in the drafting and submission of Reportable New Information (RNI) for assigned research projects. Adhere to institutional policies concerning safety and infection control.
Conduct protocol regulatory compliance reviews throughout the study lifecycle.
Provide overall regulatory support and coordination in audits (i.e., internal, external, FDA).
Other duties as assigned.
Required : Bachelor's degree.
Required: Three years experience in area of research study or direct patient care obtained from nursing, data gathering or other related experience. May substitute required education degree with additional years of equivalent experience on a one to one basis. With preferred degree, one year of required experience.
It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html
Requisition ID: 154671
Employment Status: Full-Time
Employee Status: Regular
Work Week: Days
Minimum Salary: US Dollar (USD) 53,000
Midpoint Salary: US Dollar (USD) 66,000
Maximum Salary : US Dollar (USD) 79,000
FLSA: non-exempt and eligible for overtime pay
Fund Type: Soft
Work Location: Remote (within Texas only)
Pivotal Position: Yes
Referral Bonus Available?: No
Relocation Assistance Available?: Yes
Science Jobs: No