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ASO DIR, Clinical Research

Company: Shands Jacksonville
Location: Gainesville
Posted on: March 21, 2020

Job Description:

ASO DIR, Clinical Research Job no: Work type: Staff Full-Time Location: Main Campus (Gainesville, FL) Categories: Administrative/Professional Department: - MD-PULMONARY-OTHER Classification Title: ASO DIR, Clinical Research Job Description: Responsible for designing workflow structure as well as providing the management, administrative direction, coordination, and control of activities of multiple, simultaneous Clinical Drug Trials. This laboratory holds COLA/CLIA licensure and certification. A primary function of this role will be in maintaining the laboratory in compliance with the Good Clinical/Laboratory Practices detailed in this Accreditation. Incorporation of Clinical testing design into formal Scope of Work documents as well as assist in Sponsor negotiations for Master Service Agreements and related testing budgets. Primary oversight of the regulatory and inspection processes relating to Clinical Trials study audits. Provide direct supervision of and assistance to the personnel of external auditing agencies, either Sponsor specific or Accrediting (ie COLA). This includes Site Initiation inspections, Vendor Qualification documentation as well as documenting compliance of staff with all training and licensure requirements for positions within core testing roles of the Clinical Testing group. Corrective actions and resulting response reports will be compiled for the review and approval of the Program Director. Responsible for protocol development and assay validation as necessary in collaboration with Sponsors. Updates, implements, and evaluates the quality assurance process in response to Audit feedback to verify accurate, quality data collection by all testing staff involved in Clinical Trials. Evaluate, revise and/or develop policies and procedures to insure Clinical Trials Section operations are within acceptable guidelines (NIH, FDA, OPRR, UF). Monitor and evaluate policy implementation and revise as necessary. Provide support to nursing staff in coordination and design of workflow for newly implemented Trials. Supervise the administrative support of the fiscal process and regulatory process for the Clinical Trials program. Expected Salary: $110,000 - $116,000 Minimum Requirements: Master's degree in appropriate area of specialization and four years of appropriate experience; or a bachelor's degree in appropriate areas of specialization and six years of experience. Preferred Qualifications: - Experience in GCP/GLP regulations and required documentation is a must - Ability to communicate effectively and professionally with prospective Sponsors - Ability to work independently - Ability to utilize problem-solving techniques - Ability to prepare, produce and present reports - Ability to collect, evaluate and analyze data - Knowledge of GCP, FDA, OPRR, FDA, HIPPA regulations Special Instructions to Applicants: Upload CV for consideration for this position. This is a time-limited position. Application must be submitted by 11:55 p.m. (ET) of the posting end date. Health Assessment Required:No Advertised: 17 Feb 2020 Eastern Standard Time Applications close: 24 Feb 2020 Eastern Standard Time

Keywords: Shands Jacksonville, Gainesville , ASO DIR, Clinical Research, Healthcare , Gainesville, Florida

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