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Manager, Clinical Protocol Administration

📁
Managerial/Professional
💼
Pediatrics - Patient Care 113100
📅
141440 Requisition #
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 THIS POSITION IS A HYBRID REMOTE POSITION

 

JOB SPECIFIC COMPETENCIES
Research Operations Management  Recruits, hires, disciplines and terminates staff for research projects.  Directly manages clinical research staff, in collaboration with the Principal Investigators.  Provides for the orientation and training of new employees.  Manages departmental, large-scale and multiple site research activities and processes including implementation of new and ongoing clinical trials including COG studies.  Provides direction and manages research finance for clinical trials, including billing and ensuring contractual payments received from sponsors.  Routinely reviews budgets for funded protocols in the department, and identifies future funding needs to ensure project completion.  Coordinates site initiation meetings; participates in onsite routine monitor visits and interviews with auditors; and attends investigator meetings.  Efficiently organize and monitor processes to maintain all investigational study related records.

 

 

Planning and Program Development  Provides strategic planning for clinical research grants and protocol initiatives for the department.  Ensures projects have appropriate resources, including education, staffing and administrative support.  Develops and manages implementation of systems, policies, and procedures affecting the submission, review, approval, contract negotiation, activation, regulation, tracking, and reporting of protocols as well as review and submission of grant applications and annual reports, according to institutional and external requirements.  Responsible for contract negotiations with private industry sponsors. 

 

Regulatory and Compliance   Serves as the department's contact to industry and other academic sponsors in regards to regulatory documents and processes, IRB reviews, investigator and site qualifications, protocol and informed consent revisions, CAP and CLIA laboratory certifications, COG participation, and other relevant study correspondence. Through establishment of and monitoring procedures, ensures drug accountability, regulatory compliance, quality assurance, integrity of and submission of patient data, and other regulatory activities related to execution of projects.  Coordinates systems and practices to ensure quality and regulatory compliance. Maintains study regulatory documentation and tracks submission of clinical trial regulatory records.  Facilitates investigator compliance with Good Clinical Practices, Code of Federal Regulations, institutional policies, and local IRB by-laws.

 

Planning and Execution    Provides oversight of new clinical trial protocol submissions, amendments, and informed consents for IRB approval.  Reviews eligibility for funding sources as requested, and provides assistance to PIs with protocols and development of new projects. Prepare applications and annual reports for new drug applications or devices, including correspondence with the FDA.   Collaborates with investigators on annual, interim, and final study reports.

 Communication and Coordination    Communicates pertinent information related to clinical trial budgets and contracts, study data, IRB protocol approvals and reviews, investigator materials, internal and external safety reports, and other relevant documentation with industry, sponsors, and PIs.

 

 

 

 

 

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

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 program may substitute for one year of required supervisory or management experience.

Preferred: Six years of the following experience in Grants, Contracts, Pre/Post awards. Two years of supervisor or management experience preferred. 

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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