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Manager, Clinical Protocol Administration - Research Regulatory QA
The primary purpose of the Manager, Clinical Protocol Administration position is to collaborate with the research team and Principal Investigator (PI) to coordinate clinical trial quality assurance, submission and regulatory process for the departmental. To evaluate and prioritize clinical trial inspection readiness. To provide leadership and supervision of Regulatory and Quality Assurance (QA) team ensuring that departmental clinical research is conducted in compliance with departmental process, institutional policies, the Code of Federal Regulations, and Good Clinical Practice Guidelines.
Key Functions
ADMINISTRATIVE/SUPERVISION
* Supervises the hiring, development, and evaluation process of the Regulatory and QA team.
* Coordinates schedules, training and protocol assignments for the Regulatory and QA team beginning at clinical concept presentation. Assess effort routinely. Assist in the management of the master protocol assignment sheet. Ensure changes in assignment are reflected in various tools for clinical trial management such as but not limited to protocol group email, delegation, protocol specific training, notification to sponsors/supporters and PI meeting schedule.
* Monitor and log new protocol concepts as identified on the master protocol assignment sheet and regulatory staff effort sheet.
* Develop and maintain protocol effort assessment scoring and assessment over the life of a clinical trial.
* Develops and maintains orientation trainings and checklists. Conducts routine staff meetings. Assesses the effectiveness of training programs, identifies learning needs, modifies process as needed, and manages disciplinary action as needed.
* Create, modify and develop departmental process (standard operating procedure or SOP) related to staff development and clinical trial regulation. Monitor adherence to department SOP and institutional policies. Communicates updates and changes to process and policy to the staff, formally and informally.
* Manages and assist with departmental maintenance of Human Resource files related to Regulatory and QA Team.
* Attends appropriate departmental meetings and institutional continuing education programs.
* Participate in the planning of departmental education sessions to ensure dissemination of new information, department SOP and institutional or federal regulatory policies.
* Demonstrates excellent oral and written communication skills when contacting other institutions, patients and agencies (i.e. NCI, pharmaceutical companies, sponsoring agencies, etc.) by phone, email and/or face-to-face interactions. Assimilates pertinent information in order to compose written correspondence.
CLINICAL TRIAL MANAGEMENT
* Provides leadership for Genitourinary Medical Oncology (GU Med Onc) Regulatory and QA Team assignments.
* Liaison with interdepartmental, extramural, industry research collaborators, and Contract Research Organizations (CROs) during pre-activation stage of protocols. Evaluate and resolve start up logistics with the study team and the Clinical Research Group (CRG) Managers.
* Faciltiation of applicable local, federal, institutional, and sponsor clinical trial process over the life of the protocol.
* Responds to report queries and clarifications related to ClinicalTrial.gov or NCI primary posting during life of clinical trials. Communicates with the institutional team on behalf of the PI and Protocol Team as needed.
* Coordinate strategies to enhance collaborations between investigators and clinical or research scientists.
* Development of data management tools for clinical trials as needed. Work with the departmental supervisors and managers to improve databases and reports used by the CRG.
* Participates in sponsor visits and teleconferences to stay informed and potentially enhance research activities.
* Participates in the editing, revision and submission of clinical trials in order to maintain compliance.
* Ensure staff are informed about protocol assignments and oversee the execution regulatory activities.
* Review departmental clinical trials for departmental monitoring or internal inspection. Participate in quality assurance inspection or audit of CRG. Assess adherence to relevant Federal, local policies and departmental process or guidelines.
* In collaboration with the CRG management, reviews current departmental clinical research processes to ensure relevance. Modifies and/ or develops new guidelines or workflow as requested.
* Perform quality checks on new trial builds and effort reports (including IRB submission and Protocols due to expire). Develops departmental metrics related to submission and QA.
* Review and assist the QA team with departmental monitoring and audit/inspection response.
* Consults with principal investigator (PI) regarding ongoing clinical trials especially as related to Investigator Initiated Trials (IIT). Working with the investigator and CRG Manager to ensure successful trial execution.
* Evaluates the trial feasibility with the CRG Managers as a part of clinical trial submission and activation process.
* Supplement and file relevant clinical trial communications in the regulatory file per departmental process. Perform QA checks on the regulatory and identify missing elements. Work with the study team to resolve and ensure compliance.
* Knowledge of protocol databases and electronic applications. Proficient in the use of Microsoft office applications and departmental electronic data systems such as SIP.
MAINTAINS A LEVEL OF PROFESSIONAL EXPERTISE THROUGH EDUCATIONAL PROGRAMS
* Maintains working knowledge of current Institutional Policy, Code of Federal Regulation and Good Clinical Practice (GCP) guidelines as well as a comprehensive understanding of the research trial process, including but not limited to basic eligibility and genitourinary cancer processes.
* Maintains a working knowledge of departmental clinical trial workflow in order to communicate and monitor proper execution of trial procedures including but not limited to eligibility and disease processes.
* Maintains up to date knowledge of public website updates and maintenance, including but not limited to FDA clinical trials.gov website and the NCI Clinical Trials Reporting Program (CTRP) website.
* Maintains up to date knowledge of departmental and institutional databases for execution of clinical trial workflow such as ePRTCL, CORe or replacement system, Prometheus, ClinicalTrials.gov, and others as indicated.
* Maintains knowledge of pharmaceutical databases or portals for execution of clinical trial workflow and regulatory communication such as the Shared Investigator Platform (SIP), and external IRB interfaces.
* Maintains up to date knowledge of the protocol budget creation, budget/payment schedule negotiations and Cost Determination as it affects the protocol submission and informed consent documents.
* Maintain working knowledge of multicenter regulatory collection, tracking, sharing as related to institutions and investigators compliance.
* Attend appropriate departmental meetings and institutional continuing education programs.
* Share information and, as requested by CRG leadership, develops educational presentations for the monthly CRG Townhall meetings.
OTHER
* Demonstrates excellent oral and written communication skills when contacting other institutions, patients and agencies (i.e. NCI, 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 assigned.
EDUCATON:
Required: Bachelor's degree in Science, Healthcare, Nursing or related field.
EXPEIENCE:
Required: 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 and/or LEADing Self Discover programs may substitute for one year of required supervisory or management experience. Completion of both programs can be substituted for a maximum of two years of supervisory or management experience.
Preferred: Clinical Research Regulatory QA
OTHER:
Required: 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
