MD Anderson Cancer Center Coordinator, Clinical Studies in Houston, Texas
Coordinator, Clinical Studies
Budgeting and Research Accounting:
Protocol budget creation and budget/payment schedule negotiations.
Protocol Cost Determination revision, finalization, and submission.
Completion of forms (as specified) for protocol, contract, and budget approval and activation.
Patient reimbursement processing.
Familiar with Institutional contract/financial systems.
Interaction with Sponsored Trial staff for invoice payment and reconciliation.
Accounts receivable reconciliations and invoice tracking.
No Cost Extension requests.
Assemble regulatory submissions for study activation as required per FDA regulation, sponsor standard operating procedures (SOPs), institutional and departmental standards and processes.
Timely submission of required regulatory documents, including preparation of IND related documents for Compliance Office and oversight of the FDA approval process. Create, update, and maintain current regulatory files for all GU protocols according to sponsor and departmental SOPs. Collaborate with multiple departments and/or outside institutions to maintain appropriate regulatory documentation.
Participation in routine monitoring and sufficient, appropriate, and timely responses to sponsor queries. Provides support to the study team in preparing for inspections by regulatory agencies.
Assist in development and maintenance of a regulatory document control system. Develop processes for organization, record, and coordination of regulatory-related operations. Monitor and evaluate process changes. Conduct simple analyses of processes and identify and resolve problems and quality issues.
Tracking of changes and updates in regulatory laws/guidelines as they occur. Interpret and communicate changes to appropriate team members, including management. Coordinate and implement changes as necessary.
Attendance at and preparation for study start-up meetings.
Public website updates and maintenance, including but not limited to FDA clinical trials website and the NCI Clinical Trials Reporting Program (CTRP) website.
Organization and development of the multicenter regulatory infrastructure for collection, tracking, sharing, and maintenance of relevant regulatory documentation for collaborating institutions and investigators.
Protocol preparation, review, and submission for new and amended protocol documents for the Institutional Review Board (IRB), the National Cancer Institute (NCI), the Food and Drug Administration (FDA), and other approving entities.
Quality Assurance to ensure consistency between protocol and related documents and that the protocols are written in accordance with institutional and federal guidelines governing clinical research and lab protocols.
Professional e-mail, phone, and face-to-face interaction with pharmaceutical company representatives, NCI agents, institutional physicians and staff, and others.
· Participate in the orientation process of new Clinical Research Group employees as well as ongoing training of current staff regarding regulatory matters. Obtain speakers and schedule workshops.
· Attend appropriate departmental meetings and institutional continuing education programs. Share information and develop and/or designate educational presentations for the monthly Clinical Research Group (CRG) meetings and Data Coordinator/Research Nurse staff meetings, as approved by supervisor. Prepare updates on laws/regulations for distribution to CRG members.
- Maintain working and teaching knowledge of current Code of Federal Regulation and Good Clinical Practice guidelines as well as a comprehensive understanding of the research trial process, including but not limited to eligibility and disease processes.
Education Required: Bachelor's degree.
Experience 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.
Experience Preferred: Regulatory 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: 128435
Employment Status: Full-Time
Employee Status: Regular
FLSA: non-exempt, eligible for overtime, and is subject to the provisions of the Fair Labor Standards Act (FLSA)
Work Week: Days
Fund Type: Soft
Pivotal Position: No
Minimum Salary: US Dollar (USD) 50,800
Midpoint Salary: US Dollar (USD) 63,500
Maximum Salary : US Dollar (USD) 76,200