Clinical Studies Coordinator - Lymphoma-Myeloma
- Requisition #: 171545
- Department: Lymphoma - Myeloma
- Location: Houston, TX
- Posted Date: 11/11/2024
MISSION STATEMENT
The mission of The University of Texas M. D. Anderson Cancer Center is to eliminate cancer in Texas, the nation, and the world through outstanding programs that integrate patient care, research and prevention, and through education for undergraduate and graduate students, trainees, professionals, employees and the public.
SUMMARY
JOB SPECIFIC COMPETENCIES
Sponsored Contracts, Budget negotiations, and Amendments Communicates with sponsors of clinical trials regarding needed contract and/or budget amendments. Liaise between PI, Sponsor/Sponsor representatives, Collaborating Departments, Institutional & Departmental Leaders, Clinical Research Finance (CRF), Legal, and the Office of Sponsored Programs (OSP). Initiates the coordination, creation and finalizing of relevant documents/ budgets and facilitates processes leading to Institution approval for completion; In coordination with PIs and research staff; Enhance budget process including thorough Coverage Analysis/Determination; Maintains tracking system of budget process and updates PI on the status of budget timeline; Assist in the strategic planning for the and development of clinical budgets for LOI PI-initiated and correlative studies; Route CTA(s) accordingly to accommodate New budgets and Amendments; Coordinate with the financial team to develop and monitor budget justification of expenditures as dictated by the study/protocol.
Clinical Research Program Manager Budget and Contract Oversight Develops and maintains a processing and tracking system for all protocol related paperwork; Collects and develops criteria information for protocol submission; Pre-Award activities: assist faculty with initial study planning; acquire lab manual, create advanced set up, assist in review of coverage determinations, budget preparation and review negotiation; Execute proposal and clinical protocol for submission of Material Transfer Agreements (MTA) and Clinical Trial Agreements (CTA) for Legal review, review/negotiate payment term; Provide pre-/post-award management of assigned budget(s), contract(s), and/or clinical research activities.
Budget Management Leads all budget management efforts for clinical trials as assigned by team and as needed based on departmental priorities and disease team priorities. Ensures conduct of assigned studies is in accordance with Good Clinical Practice, federal regulations and institutional policies. Interact with NCI and Pharmaceutical industry to correct/update protocol documents. Communicate verbally and in writing as needed or as requested by the principal investigator of the study, internal reviewers, external agencies, Institutional Review Board and Clinical Research Finance.
Other duties as assigned
Required Education:
Bachelor's degree.
Preferred Education:
Master's degree.
Required Experience:
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.
Preferred Experience:
Experience working on clinical trials, clinical trial budget submission, and experience working in Excel.
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
Additional Information
#LI-Remote
The mission of The University of Texas M. D. Anderson Cancer Center is to eliminate cancer in Texas, the nation, and the world through outstanding programs that integrate patient care, research and prevention, and through education for undergraduate and graduate students, trainees, professionals, employees and the public.
SUMMARY
JOB SPECIFIC COMPETENCIES
Sponsored Contracts, Budget negotiations, and Amendments Communicates with sponsors of clinical trials regarding needed contract and/or budget amendments. Liaise between PI, Sponsor/Sponsor representatives, Collaborating Departments, Institutional & Departmental Leaders, Clinical Research Finance (CRF), Legal, and the Office of Sponsored Programs (OSP). Initiates the coordination, creation and finalizing of relevant documents/ budgets and facilitates processes leading to Institution approval for completion; In coordination with PIs and research staff; Enhance budget process including thorough Coverage Analysis/Determination; Maintains tracking system of budget process and updates PI on the status of budget timeline; Assist in the strategic planning for the and development of clinical budgets for LOI PI-initiated and correlative studies; Route CTA(s) accordingly to accommodate New budgets and Amendments; Coordinate with the financial team to develop and monitor budget justification of expenditures as dictated by the study/protocol.
Clinical Research Program Manager Budget and Contract Oversight Develops and maintains a processing and tracking system for all protocol related paperwork; Collects and develops criteria information for protocol submission; Pre-Award activities: assist faculty with initial study planning; acquire lab manual, create advanced set up, assist in review of coverage determinations, budget preparation and review negotiation; Execute proposal and clinical protocol for submission of Material Transfer Agreements (MTA) and Clinical Trial Agreements (CTA) for Legal review, review/negotiate payment term; Provide pre-/post-award management of assigned budget(s), contract(s), and/or clinical research activities.
Budget Management Leads all budget management efforts for clinical trials as assigned by team and as needed based on departmental priorities and disease team priorities. Ensures conduct of assigned studies is in accordance with Good Clinical Practice, federal regulations and institutional policies. Interact with NCI and Pharmaceutical industry to correct/update protocol documents. Communicate verbally and in writing as needed or as requested by the principal investigator of the study, internal reviewers, external agencies, Institutional Review Board and Clinical Research Finance.
Other duties as assigned
Required Education:
Bachelor's degree.
Preferred Education:
Master's degree.
Required Experience:
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.
Preferred Experience:
Experience working on clinical trials, clinical trial budget submission, and experience working in Excel.
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
Additional Information
- Requisition ID: 171545
- Employment Status: Full-Time
- Employee Status: Regular
- Work Week: Days
- Minimum Salary: US Dollar (USD) 55,500
- Midpoint Salary: US Dollar (USD) 69,500
- Maximum Salary : US Dollar (USD) 83,500
- FLSA: non-exempt and eligible for overtime pay
- Fund Type: Soft
- Work Location: Remote (within Texas only)
- Pivotal Position: No
- Referral Bonus Available?: No
- Relocation Assistance Available?: No
- Science Jobs: No
#LI-Remote
