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The University of Texas MD Anderson Cancer Center is ranked the nation's top hospital for cancer care by U.S. News & World Report's "Best Hospitals." MD Anderson's mission is to eliminate cancer in Texas, the nation and the world through exceptional programs that integrate patient care, research and prevention.

Research Data Coordinator - Regulatory Team

The ideal candidate will have a Bachelor's degree and must be interested in a career in clinical research regulations.

JOB-SPECIFIC COMPETENCIES

Clinical Trials Regulatory Management

• Assist in the coordination of regulatory correspondence and maintenance of FDA-required documentation on all departmental clinical trials.

• Communicate verbally and in writing with pharmaceutical sponsors to address regulatory queries.

• Complete forms and comply with institutional, state, and/or federal regulations for study initiation, conduct, and termination.

• Assist in coordinating and sending outgoing material and correspondence to institutional, state, and/or federal agencies.

• Maintain the electronic filing system (eREG binder) and ensure that appropriate personnel have access.

• Ensure timely completion and submission of Institutional Review Board (IRB) annual Continuing Reviews and assist with any subsequent contingencies.

Coordination of Clinical Trials Regulatory Functions

• Coordinate research meetings and site initiation visits and inform department staff, as needed.

• Schedule research meetings and complete all related tasks, including obtaining equipment, making conference room reservations, and inviting appropriate speakers and collaborators.

• Generate documents using word processing, spreadsheet, and other software to produce a professional appearance.

Departmental Standards and Training

• Evaluates the effectiveness, accuracy, and training needs of the department.

• Coordinates and plans the training programs and ensures compliance with departmental standards.

• Collects and develops criteria and processes information for departmental approval and protocol submission.

• Conducts orientation for faculty, trainees, and research/administrative support personnel - standardizes training practices for this purpose.

• Provides direct/indirect oversight of research and/or faculty support staff in the management of protocol-related activities such as regulatory setup, activation, monitoring, and reporting.

Information Systems & Reporting

• Develops and maintain a processing and tracking system for all protocol-related paperwork.

• Establishes and participates in information systems for the development of research programs including writing, processing, submission, and maintenance of protocols. Reports both in detail and in summary for productivity and responsiveness on a monthly, quarterly, and annual basis.

Audit and Quality Monitoring

• Prepares and coordinates audit/monitor visits for protocol compliance and data quality review.

• Generate reports as requested. Assures accurate documentation.

• Under the supervision of the Principal Investigator (PI) and supervisor/manager, assists the team in the overall conduction of assigned clinical trials.

• Participates in Site Initiation Visits (SIVs), conference calls, and protocol meetings.

• Tracks and manages all relevant protocol paperwork and essential documents in accordance with sponsor requirements and institutional policies and procedures.

• Provides coverage for other coordinators, informs appropriate staff, and arranges coverage for necessary functions as needed.

Other duties as assigned

REQUIREMENTS

Required Education: High school diploma or equivalent.

Preferred Education: Bachelor's degree.

Required Experience: Two years of related experience in the area of research study or direct patient care obtained from nursing, data gathering, or other related experience. With a preferred degree, no experience is required.

Preferred Experience: Demonstrates experience in Good Clinical Practices (GCP) and the Code of Federal Regulations, at an exceeded and/or outstanding level.

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: 160262
• Employment Status: Full-Time
• Employee Status: Regular
• Work Week: Day/Evening, Days
• Minimum Salary: US Dollar (USD) 34,500
• Midpoint Salary: US Dollar (USD) 43,000
• Maximum Salary : US Dollar (USD) 51,500
• FLSA: non-exempt and eligible for overtime pay
• Fund Type: Soft
• Work Location: Hybrid Onsite/Remote
• Pivotal Position: No
• Referral Bonus Available?: No
• Relocation Assistance Available?: No
• Science Jobs: No

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