The Immunology department at MD Anderson Cancer Center seeks to determine the fundamental cellular and molecular mechanisms of a wide range of processes by which the body recognizes and eliminates pathogens and use these findings to unleash the patient's own immune system against previously treatment-resistant cancers. Treating the immune system rather than the cancer itself, the therapeutics developed are applicable to many cancers.The ideal candidate will be familiar with EPIC, protocol management, budgeting, regulatory compliance and good clinical practice (GCP).KEY FUNCTIONSAdministrative
Research Planning, Oversight And Management
- Represent the Immunotherapy Platform (IMT) at meetings and functions, record meeting minutes and action items as needed.
- Coordinate educational activities and routine meetings for research staff.
- Monitor and evaluate process changes.
- Conduct simple analyses of processes and identify and resolve problems and quality issues.
- Participates in developing departmental policies and procedures related to protocol research and executes quality assurance initiatives.
- Coordinates research contracts preparation and execution.
- Assists with creating presentations and visual aids, as needed, concerning IMT associated studies, project milestones, metrics, quality assurance, and regulatory affairs.
- Prepares and submits various reports to IMT scientists, investigators, regulatory authorities, director(s), and collaborators, as requested.
- Collaborates with physicians, research staff, and other stakeholders to meet deadlines and milestones.
- Tracks PA13-0291 billable activities, research charges.
- Ensure that charges to the study account are accurate and in compliance with internal and external rules and regulations, coordinate with collaborating departments when necessary.
- Implement a research charge tracking mechanism for IMT associated studies, including creating and completing protocol tracking systems and reconciling charges billable to IMT.
- Assist with protocol budget planning, creation, and management.
- Provides budget information for research projects, including estimates for expenses for research-related activity, payment schedules, clinical research agreements/amendments relating to trial conduct, and logistics.
- Ensure appropriate allocation of funds and any necessary adjustment to accommodate study-specific needs.
- Provides data regarding research finance to requesting directors, PIs, or other research staff.
- Support routine invoicing according to the contractual payment schedule and collaborating department reimbursement.
- Other duties as assigned.
- Attendance at IMT associated study start-up meetings (SIVs).
- Schedule and host PA13-0291 training for staff in participating departments, covering protocol requirements, specimen collection processes to obtain samples (including, but not limited to, blood, bone marrow aspirate, and tissue samples), and IMT expectations.
- Maintains the Prometheus database by tracking research training for all personnel involved in the conduct of PA13-0291 and ensuring the delegation of authority log (DOA) is up to date. Connects with participating departments to identify training opportunities and to reflect staffing changes in the DOA log.
- Track the progress of institutional trials associated with the IMT, including preactivation (IND, CRC, IRB approval) status, trial accrual, specimen collection details, and other requested information.
- Provide reports as requested.
- Ensure that clinical research conducted by IMT and PA13-0291 delegates meets IRB, federal, and institutional guidelines and policies.
- Assist with preparation for audits as needed.
- Assist in developing and maintaining regulatory document control systems and ensuring that the information collected is accurate, reflects the required information, and is per specified guidelines.
- Routinely distributes appropriate communication and timely responses to internal collaborators (i.e., investigators, scientists, MDACC research staff) and external agencies (i.e., pharmaceutical alliances, vendors.).
- Attends appropriate departmental meetings and institutional continuing education programs.
- Maintains working knowledge of current Code of Federal Regulations and Good Clinical Practice guidelines as well as comprehensive understanding of the research trial process, including but not limited to eligibility and disease processes.
- Participates in protocol development and submissions of IMT associated clinical studies and ensures regulatory compliance.
- Reviews protocols and ancillary documents for clarity, formatting, consistency, and compliance.
- Ensures appropriate language to cover IMT activities.
- Works with PI, study team, and industry partners to resolve any issues.
- Ensure timely protocol preparation, review, and submission for new and amended protocol documents, to include PA13-0291 and IMT associated studies (as needed)
- Demonstrates excellent oral and written communication skills when contacting other institutions and agencies (i.e. industry partners, vendors, etc.) by phone, email and/or face to face interactions.
- Assimilates pertinent information in order to compose written correspondence.
Required: Bachelor's degree.
Preferred: Master's degree.Experience
Required: Five years experience in area of research study or direct patient care obtained from nursing, data gathering or related field. May substitute required education degree with additional years of equivalent experience on a one to one basis. With preferred degree, three years of required experience.
Preferred: EPIC, protocol management, budgeting, regulatory compliance and good clinical practice (GCP).
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