Clinical Protocol Administration Manager
Full Time
Houston, TX 77030
Posted
Job description
SUMMARY
The primary purpose of the Manager, Clinical Protocol Administration position is to provide clinical research finance, grant administration, and research operations support for the submission and management of research trials contracts and grants in the Department of Surgical Oncology.
JOB SPECIFIC COMPETENCIES
Clinical Research Finance Responsible for negotiating contractual language between sponsor and Grants and Contracts and communicating with the PI for approval. Communicates all budget aspects to the Principal Investigator for approval. Reviews the coverage analysis with the assigned research personnel and the Principal Investigator and ensures all research related costs are captured on the budget. Works with research personnel to create payment spreadsheet. Works with Clinical Research Finance on review and finalization of budget and with Legal on contract negotiation on all clinical sponsored agreements. Obtains all required signatures on all budget-related documents (i.e., contract and coverage analysis). Ensures all contracts are fully executed and copies are obtained and filed for research records. Routes contracts for review and negotiation, tracks the progress, and communicates the status to the PI. Responsible for creating study budgets to include personnel salary, tissue bank charges, pharmacy charges, and any other miscellaneous charges including invoiceable items. Reviews award set-up to ensure that budget categories match budget. Facilitates invoices for completion and submits for all payment time points. Monitors that all funds are received for all payment time points and applied to appropriate company center. Works with GCA to ensure timely closure of fund accounts at the time of completion and sweeping of remaining funds to company. Requests no-cost extensions for accounts as required. Requests transfer of expenses between accounts as required. Resolves all overdrafts on research related accounts. Coordinates the renewals of all expiring research related contracts that require renewals. Monitors and ensures that all clinical research related funds are invoiced and payment is received to PI's account in a timely manner according to the contract agreement.
Grant Administration Supports all aspects of grant awards pre-award/post-award including the audit process. Works with the Grants Team to maintain/create a database of all departmental grants for the administrative grants file to include pending, new and existing grants and/or proposals. Verify accuracy and generate reports for the Department/Leadership. Assures that monthly financial reports are provided to the faculty to include account balances and salary projections for their respective grant funds. Works with the faculty/Department Leadership to prepare cost projections and budgets for grant-funded research. Maintains familiarity with grant guidelines for various funding agencies in order to advise faculty and staff in preparing and submitting grant applications.
Research Operations Works with department leadership, managers, and study team to ensure that budgets are clearly understood and managed correctly per protocol. Responsible for maintaining financial and research databases for internal tracking at all stages of the research continuum. Provides comprehensive support for all aspects of all departmental awards and reports appropriately. Participates in the planning, monitoring, execution, and close-out of research activities including protocol development and submission, study prioritization and feasibility, study activation, monitoring, data support, invoice/budget reconciliation, and effort certification. Attends appropriate departmental and research meetings and institutional continuing education programs. Maintains working knowledge as well as a comprehensive understanding of the research trial and funding process.
Required Education:
Bachelor's degree in Science, Healthcare, Nursing or related field.
Required Experience:
Six years of extensive research administrative experience in a biotechnology or academic setting to include two years experience with research protocols, grants and contracts and two years supervisory/management experience. May substitute additional experience for required education (or vice versa) on a one to one year basis. Successful completion of the LEADing Self Accelerate program may substitute for one year of required supervisory or management experience.
Preferred Experience/Skills:
Research finance, accounting, reconciliation, and salary distribution experience, budget development and negotiation experience, understanding of clinical trial research/study funding and environment. Highly organized and comfortable with multiple protocols and accounts, clear, consistent, and thorough communication verbally and written (email and study documentation), proper responsiveness and follow-up/through of sponsor and study issues, high team/collaborative spirit.
Work Schedule: Willingness/ability to come on-site as needed for non-remote work activities.
Other Requirements:
Must pass pre-employment skills test as required and administered by Human Resources.
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-Hybrid
The primary purpose of the Manager, Clinical Protocol Administration position is to provide clinical research finance, grant administration, and research operations support for the submission and management of research trials contracts and grants in the Department of Surgical Oncology.
JOB SPECIFIC COMPETENCIES
Clinical Research Finance Responsible for negotiating contractual language between sponsor and Grants and Contracts and communicating with the PI for approval. Communicates all budget aspects to the Principal Investigator for approval. Reviews the coverage analysis with the assigned research personnel and the Principal Investigator and ensures all research related costs are captured on the budget. Works with research personnel to create payment spreadsheet. Works with Clinical Research Finance on review and finalization of budget and with Legal on contract negotiation on all clinical sponsored agreements. Obtains all required signatures on all budget-related documents (i.e., contract and coverage analysis). Ensures all contracts are fully executed and copies are obtained and filed for research records. Routes contracts for review and negotiation, tracks the progress, and communicates the status to the PI. Responsible for creating study budgets to include personnel salary, tissue bank charges, pharmacy charges, and any other miscellaneous charges including invoiceable items. Reviews award set-up to ensure that budget categories match budget. Facilitates invoices for completion and submits for all payment time points. Monitors that all funds are received for all payment time points and applied to appropriate company center. Works with GCA to ensure timely closure of fund accounts at the time of completion and sweeping of remaining funds to company. Requests no-cost extensions for accounts as required. Requests transfer of expenses between accounts as required. Resolves all overdrafts on research related accounts. Coordinates the renewals of all expiring research related contracts that require renewals. Monitors and ensures that all clinical research related funds are invoiced and payment is received to PI's account in a timely manner according to the contract agreement.
Grant Administration Supports all aspects of grant awards pre-award/post-award including the audit process. Works with the Grants Team to maintain/create a database of all departmental grants for the administrative grants file to include pending, new and existing grants and/or proposals. Verify accuracy and generate reports for the Department/Leadership. Assures that monthly financial reports are provided to the faculty to include account balances and salary projections for their respective grant funds. Works with the faculty/Department Leadership to prepare cost projections and budgets for grant-funded research. Maintains familiarity with grant guidelines for various funding agencies in order to advise faculty and staff in preparing and submitting grant applications.
Research Operations Works with department leadership, managers, and study team to ensure that budgets are clearly understood and managed correctly per protocol. Responsible for maintaining financial and research databases for internal tracking at all stages of the research continuum. Provides comprehensive support for all aspects of all departmental awards and reports appropriately. Participates in the planning, monitoring, execution, and close-out of research activities including protocol development and submission, study prioritization and feasibility, study activation, monitoring, data support, invoice/budget reconciliation, and effort certification. Attends appropriate departmental and research meetings and institutional continuing education programs. Maintains working knowledge as well as a comprehensive understanding of the research trial and funding process.
Required Education:
Bachelor's degree in Science, Healthcare, Nursing or related field.
Required Experience:
Six years of extensive research administrative experience in a biotechnology or academic setting to include two years experience with research protocols, grants and contracts and two years supervisory/management experience. May substitute additional experience for required education (or vice versa) on a one to one year basis. Successful completion of the LEADing Self Accelerate program may substitute for one year of required supervisory or management experience.
Preferred Experience/Skills:
Research finance, accounting, reconciliation, and salary distribution experience, budget development and negotiation experience, understanding of clinical trial research/study funding and environment. Highly organized and comfortable with multiple protocols and accounts, clear, consistent, and thorough communication verbally and written (email and study documentation), proper responsiveness and follow-up/through of sponsor and study issues, high team/collaborative spirit.
Work Schedule: Willingness/ability to come on-site as needed for non-remote work activities.
Other Requirements:
Must pass pre-employment skills test as required and administered by Human Resources.
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: 156994
- Employment Status: Full-Time
- Employee Status: Regular
- Work Week: Days
- Minimum Salary: US Dollar (USD) 76,000
- Midpoint Salary: US Dollar (USD) 95,000
- Maximum Salary : US Dollar (USD) 114,000
- FLSA: exempt and not eligible for overtime pay
- Fund Type: Soft
- Work Location: Hybrid Onsite/Remote
- Pivotal Position: No
- Referral Bonus Available?: No
- Relocation Assistance Available?: No
- Science Jobs: Yes
#LI-Hybrid
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