Senior Clinical Studies Coordinator (Immunology)

Location
Houston, Texas
Salary
Competitive
Posted
June 01 2021
Ref
140072
Discipline
Health Sciences
Organization Type
Healthcare/Hospital
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.

KEY FUNCTIONS

ADMINISTRATIVE
  • Ongoing training and guidance of IMT personnel, as applicable, regarding institutional and external regulation, protocol document submission preparation, and required documentation for submissions and regulatory files
  • Coordinates educational activities for the research staff, as requested by supervisor
  • Conducts routine meetings with research staff
  • Collaborates with the writing of research policies/processes and implements quality assurance initiatives.
  • Participates in the planning and implementation of cross-departmental activities including clinical trials, protocol development, submission and approval process, regulatory compliance, and prioritization and feasibility
  • Represents the platform at meetings and functions
  • Ensures that clinical research conducted by the platform meets IRB, federal, institutional and other applicable guidelines and policies


RESEARCH PLANNING, OVERSIGHT AND MANAGEMENT
  • Develops systems, policies and procedures affecting the submission, review, approval and tracking of protocols plus contract negotiation and execution, according to institutional and external requirements
  • Manages large-scale and multi-departmental research activities including implementation of clinical trials, protocol development, submission and approval process, regulatory compliance, monitor and evaluate process changes. Conduct simple analyses of processes and identify and resolve problems and quality issues
  • Tracks progress of institutional trials associated with the IMT Platform, including pre-activation status, accrual, specimen collection details, and other requested information. Provide reports as requested
  • Assists with overseeing and training staff to obtain research samples including, but not limited to, blood, bone marrow aspirate, and tissue samples
  • Ensures appropriate training for participating departments relating to trial procedures, specimen collection processes, and IMT Platform expectations
  • Attendance at and set-up/coordination of study start-up meetings
  • Assists with preparation for audits as needed. Assist in development and maintenance of regulatory document control system


PROTOCOL MANAGEMENT

Protocol Submissions
  • Ensures the timely protocol preparation, review, and submission for new and amended protocol documents
  • Efficient collaboration with physicians, research nurse supervisors(s), laboratory manager, and other personnel to ensure that deadlines are met and all protocols are properly formatted, and contain appropriate related documents and appendices
  • Collaboration with industry sponsors and supporters, as necessary, to ensure compliance with private industry operating procedures relating to protocol document language
  • Appropriate communication and timely responses to internal reviewers and external agencies (pharmaceutical companies, government sponsors, etc.)


BUDGETS AND RESEARCH ACCOUNTING
  • Assists with protocol budget creation, budget and payment schedule negotiations, clinical research agreements/amendments relating to compensation language and trial conduct and logistics
  • Implements a research charge tracking mechanism, including creating and completion of protocol tracking systems for each applicable study and reconciliation of all charges. Ensure that billing to all accounts is accurate and in compliance with internal and external rules and regulations
  • Supports routine invoicing according to contractual payment schedule and collaborating department reimbursement.
  • Account reconciliation for IMT to include appropriate allocation of funds and any necessary adjustment to accommodate study-specific needs


REPORTING AND TEAM BUILDING
  • Attendance at relevant meetings and conferences as needed
  • Preparation of quality reports and metrics for monthly meetings


MAINTAINS A LEVEL OF PROFESSIONAL EXPERTISE THROUGH EDUCATIONAL PROGRAMS
  • 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.


OTHER
  • Demonstrates excellent oral and written communication skills when contacting other institutions, patients and agencies (i.e. pharmaceutical companies, sponsoring agencies, etc) by phone, email and/or face-to-face interactions. Assimilates pertinent information in order to compose written correspondence.
  • Other duties as required.


Education

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.

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

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