MD Anderson Cancer Center Senior 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 2017 rankings. It is one of only 49 comprehensive cancer centers designated by the National Cancer Institute.
The primary purpose of the Senior Coordinator, Clinical Research Program position is to be responsible for the development, negotiation and finalization of budgets and contracts for clinical trials and serves as a finance liaison for finance interactions between GIMO, Clinical Research Finance Dept., the Office of Grants and Contracts and legal office, and various industry sponsors. In addition to working closely with the institution personnel, this position also communicates regularly with pharmaceutical company representatives. Specifically this position will have oversight of all industry and federal sponsored clinical trials budgets and contracts (pre-award).
The salary range is: min-$59,600 and mid-$74,500 and max-$89,400.
FINANCIAL MANAGEMENT OF CLINICAL TRIALS
• Manages administrative/budget and contract aspects of research trials including federal and pharmaceutical funded protocols, through all components of a study.
• Work with study Principal Investigator (PI) by providing administrative support to develop, implement and complete research studies.
• Independently prepares protocol budgets and contracts that comply with regulatory and institutional requirements.
Works with study sponsors and/or Clinical Research Organizations (CROs) to develop budget documents that conform to both MD Anderson and Sponsor requirements.
-Negotiates directly with the study sponsor and/or Clinical Research Organizations (CROs) on behalf of the department/PI to ensure costs and payments are appropriate.
-Presents status updates of assigned budgets in weekly team meetings.
• Coordinates activities associated with site start-up and overall financial trial management.
• Acts as a liaison with private industry pharmaceutical companies and legal services to aid in the completion of language appropriate for clinical trials.
• Collaboratively works with all department clinical faculty to provide support for clinical trials goals.
• Orients new faculty/support personnel on department's clinical trials research infrastructure and procedures.
MAINTENANCE OF INTEGRITY OF CLINICAL TRIALS
• Works with Clinical Research Finance (CRF) department personnel and GIMO clinical staff (study managers, Nurse Supervisor and Manager, PI, etc...) to review and approve the preliminary and final versions of the Coverage Analysis, accurately reports any discrepancies, and reports suggestions for correction to appropriate staff.
• Presents final coverage analysis information at Pre-SIV to ensure that all clinical trial staff understand which tests are SOC and which are research.
• Creates, updates, and maintains organizational files which include all pertinent correspondence and information regarding pre-award activities for GIMO clinical trials. Maintains an up-to-date status report and creates summary reports as requested for supervisor, PI, and/or management staff.
• Ensure all investigator contracts are reviewed and approved by legal prior to execution;
• Issue and track confidentiality disclosure agreements (CDAs), if required; prepare program/study status reports for management
• Review, negotiate and approve the terms and conditions for complexed contracts in accordance with internal policy and applicable laws;
• Develop and approve investigator site and baseline budget;
• Tracks, by sponsor, all sponsor communication for reference for future budget design and negotiation.
• Works with principal investigators in the development and implementation of research protocol in regards to the budgeting process for investigator initiated protocols.
• Works closely with the regulatory team in the department in regard to protocols (e.g. addition of investigators, amendments, serious adverse events, consent form changes, monitoring visits, correspondence, continuing review and study termination reports) to ensure quality study flow and that all governing regulations are being adhered to.
• Relays timely information to Supervisors, Administrative Director of Protocol Research, and Department Administrator in regards to budget and/or contract (e.g. addition of responsibilities necessitating budget changes; inadequate sponsor budget in relation to clinical trial costs, etc.) to ensure quality study flow and accurate budgeting.
• Manage the process of subsequent contract amendments, note to files and other contract related requests;
• Assist colleagues with the resolution of problems related to contract terms and conditions, compliance with sponsor and institutional policy, and any other contract related issues;
• Processes budget and contract changes for protocol amendments.
• Reviews protocols, amendments, and ancillary documents for discrepancies and/or lack of clarity. Works with PI and/or Sponsor to resolve these.
• Prepares and submits various reports to sponsors, investigators, regulatory authorities, and any others deemed necessary.
COMPLIANCE AND EDUCATION
• Ensures compliance with Good Clinical Research Practice standards.
• Attends in-services, departmental meetings, mandatory training, and/or other events to remain abreast of new policies/procedures affecting the conduct of protocols.
• Disseminates pertinent information to other team members. Participates in the development of departmental policies and procedures related to protocol research.
• Assists in the development of in-service educational events for GIMO team members.
• Maintains knowledge of clinical trials process
-Serves as a subject matter expert and trains new staff as needed.
Required: Bachelor's degree in Nursing, Public Health, Healthcare Administration or related scientific field.
Preferred: Master's degree in Nursing, Public Health, Healthcare Administration, Finance, or related scientific field.
Required: Eight years experience in area of research study obtained from nursing, data gathering or other related experience. With preferred degree, six years of required experience.
Preferred: Clinical trial budget and contract 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