Develops, verifies and implements procedures to accomplish SCCC research goals. Reviews research protocol compliance and participant adherence to protocol: Reviews documentation of patient/participant screening procedures completed by Principal Investigator and CRS staff and reviews relevant medical information from patient clinic charts/medical records. Reviews logs/progress reports to track protocol compliance for both currently enrolled as well as follow-up patients/participants. Determines data to be collected and provides QC of Clinical Trial Management System (CTMS): Develops forms for collecting/summarizing data. Ensures data integrity and consistency in CTMS and written records. Supports corrections/queries resolution of audits/monitor visits and takes action to develop and implement CAPAs as needed. Establishes/maintains contact with CRS employees, health care providers, community agencies and study sponsors. Updates appropriate agencies (such as sponsors, IRB, etc.) regarding current status of research project. Provides education to staff about research protocols.
Supports the development and implementation of a CRS employee orientation program. Participates in the implementation coordination and execution of the continuing education program for CRS employees.Assists with the design, conduct, and implementation of education and training programs for investigators, clinical research coordinators, and research staff in general and with specific emphasis on cooperative group trials.Quality Initiatives:
Works closely with the CRS QM and other CRS staff and outside quality control personnel, on overseeing all CAPA initiatives. Provides support, coordination and quality initiatives primarily for the National Group protocols and non IND Investigator Initiated Studies. This includes working with CRS staff to address data timeliness and query resolution. Supports the development and management of the CRS SOP portfolio. Participates in the development of general goals, process improvement plans, and training activities related to research compliance. Works closely with the CRS QM to develop and enhance systems and processes as required to improve efficiencies, compliance and quality of the CRS operation.
Bachelors degree and three or more years relevant work experience; or equivalent combination of education/experience that includes four years in the clinical trials arena.
Medical and/or science education strongly preferred.
Clinical research certification required or commitment to obtain research certification within 1 year of employment.
Oncology and cooperative group clinical trial experience preferred.
High-level interpersonal skills are required.
Excellent English oral and written communication skills required.
Thorough understanding of Good Clinical Practice guidelines and the Code of Federal Regulations required.
Proficient with Microsoft Office Suite including Excel and Power Point.
Knowledge of medical terminology.
Ability to manage multiple tasks simultaneously.
Attention to detail & accuracy.
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Patient safety is a top priority. As a result, during the Influenza ("the flu") season (September through April), the University of Miami School of Medicine requires all employees who provide ongoing services to patients, work in a location (all Hospitals and clinics) where patient care is provided, or work in patient care or clinical care areas, to have an annual influenza vaccination. Failure to meet this requirement will result in rescinding or termination of employment.]]>