The primary purpose of the Manager, Clinical Protocol Administration position is to lead and collaborate with the research team and Principal Investigator (PI) to manage and evolve clinical trial data activities for the department. This position provides leadership and management of the Data Team to ensure clinical research is conducted efficiently, incorporating state-of-the art technologies and methods, and in compliance with departmental process, institutional policies, the Code of Federal Regulations, and Good Clinical Practice Guidelines.

ADMINISTRATIVE/SUPERVISION

Manages the hiring, development, and evaluation process of the Data Team.

Coordinates schedules, training and protocol assignments for Data Team beginning at clinical concept presentation. Assesses effort routinely.

Ensures changes in assignment are reflected in various tools for clinical trial management (such as, but not limited to, protocol group email, delegation logs, protocol specific trainings, notification to sponsors/supporters and PI meeting schedules).

Creates and maintains policies relating to protocol data management and staff development. Monitors adherence to policies and ensures the maintenance of development files for the Data Team.

Develops and maintains 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 actions as needed.

Creates, modifies and develops departmental process (standard operating procedure or SOP) related to staff development and clinical trial data. Monitors adherence to department SOP and institutional policies. Communicates updates and changes to process and policy to the staff, formally and informally.

Attends appropriate departmental meetings and institutional continuing education programs.

Participates 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 the Data Team assignments.

In collaboration with the Clinical Research Group management, reviews current departmental clinical research policies and processes to ensure relevance, and modifies and/ or develops new guidelines and new tools that incorporate state-of-the art methodologies as needed.

Serves as liaison with interdepartmental, extramural, industry research collaborators, and Contract Research Organizations (CROs) during pre- and post-activation stages of protocols.

Assists in evaluating and resolving start up logistics with the study team and the Clinical Research Group (CRG) Managers, and participates in pre-activation meetings including pre-site initiation visits, site initiation visits, and logistics meetings.

Manages the Supervisors, Data Team, communicates routinely with intradepartmental, extramural, and industry research collaborators regarding queries, data entry, database issues, protocol status, and other events.

Manages and collaborates in the development of data management tools and training modules for multicenter protocols as needed when the department's faculty are the lead, in collaboration with CRG Managers and the CRG Director.

Coordinates strategies to enhance collaborations between investigators and clinical or research scientists.

Participates in site initiation visits and teleconferences to enhance multicenter research activities.

Ensures the maintenance of accurate protocol assignment sheet and oversees the execution of all CRG reports of trial data activities.

Assists with internal quality assurance audits of clinical research group related to data management and the adherence to relevant Federal, local and departmental policies, process or guidelines.

Participates in sponsor visits and teleconferences to stay informed and potentially enhance research activities.

Assists the QA team with departmental monitoring and audit/inspection response.

Consults with principal investigator (PI) and CRG Managers regarding ongoing clinical trials especially as related to Investigator Initiated Trials (IIT) to ensure successful trial execution.

DATA MANAGEMENT & EDUCATION

Works closely with CRG Managers and CRG Director in the development of novel data management tools to improve data quality and increase process efficiency.

Works closely with principal investigator (PI) regarding ongoing clinical trials. Works closely with research nursing team to ensure consistency between protocol database and source documentation; includes generating written queries for missing/deficient source documentation and assisting research nurse as needed reviewing and correcting study-related forms

Supports the development and implementation of data quality inspection processes to facilitate data conceptualization, pre-processing, curation, provenance, and collection.

Manages the preparation of quality reports and metrics for the purpose of grant submissions, budget creation, clinical trial evaluations, protocol review presentations, data review events, audits, conferences, posters, and manuscripts as required by the department. Identifies missing elements in the source documentation or regulatory file.

Drafts/reviews documents, educational reference materials, and study manuals. Manages the processes of submission, revision and approval of these documents. Manages the training process of new staff, orientation, on-boarding and continuing education. Updates study staff on EPIC system updates.

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.

Maintains working knowledge of multicenter regulatory collection, tracking, sharing as related to institutions and investigators compliance.

Attends appropriate departmental meetings and institutional continuing education programs.

Shares information and, as requested by CRG leadership, develops educational presentations for the monthly CRG Townhall meetings.

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.

EDCUCATION:

Required: Bachelor's degree in Science, Healthcare, Nursing or related field.

EXPERIENCE:

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: Experience with clinical trial data.

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

Additional Information

• Requisition ID: 168510

• Employment Status: Full-Time

• Employee Status: Regular

• Work Week: Days

• Minimum Salary: US Dollar (USD) 80,000

• Midpoint Salary: US Dollar (USD) 100,000

• Maximum Salary : US Dollar (USD) 120,000

• FLSA: exempt and not eligible for overtime pay

• Fund Type: Soft

• Work Location: Hybrid Onsite/Remote

• Pivotal Position: Yes

• Referral Bonus Available?: Yes

• Relocation Assistance Available?: Yes

• Science Jobs: Yes

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