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Sr Clinical Research Spec
Houston, TX 77030 United States
The primary purpose of the Sr. Clinical Research Specialist position is to manage large-scale multi-protocol, multi-institutional, clinical trial and cancer control projects. Affects research protocols and patients in designated protocols. Scope of position is defined by the Nurse Practice Act of the State of Texas and requires adherence to the policies and procedures of the Institution.
Manage large-scale multi-protocol, multi-institutional, clinical trial and cancer control projects through the application of Clinical Nursing and Research experience with multiple treatment modalities, and for a wide range of malignancies. Function as project manager, including design, implementation, monitoring and reporting status, ensuring on-time, and on-budget performance. Participate in Budget planning activities. Requires critical thinking and independent decision-making. This position requires excellent verbal and written communication skills.
Provide Quality Assurance Services that require a working knowledge of the Pathophysiology of multiple disease processes and the prognoses for the same. Apply working knowledge of Industry Standard and Investigational Treatment modalities, and their expected outcomes and side effects.
Utilize Nursing experience and clinical judgment to monitor patient safety reports and to verify protocol compliance based on data received in-house.
Prepare, review and approve audit reports.
Communicate audit results to NCI and/or sponsor and OMCR management. Review and evaluate corrective action plans. Requires overnight travel.
Prepare and implement project specific training programs and materials for presentation at Investigator and Coordinator meetings. May require overnight travel.
Responsible for the management of assigned project personnel, which may include, Clinical Research Specialist, Sr. Coordinator of Research Data, Coordinator of Research Data, and others. Evaluate and determine project specific priorities and delegate duties to assigned personnel. This position requires excellent management and organizational skills, resource planning and the ability to work autonomously.
Job Description-Requirements EDUCATION
Required: Graduation from an approved school of professional nursing.
Preferred: Bachelor of Science degree in Nursing
Required: Current Texas license to practice professional nursing.
Preferred: Human Subject Research Certification
Required: Eight years of experience to include 5 years of nursing and some research/oncology experience.
Preferred: One year auditing experience.
Education, training, experience:
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