Fred Hutchinson Cancer Research Center

Senior Clinical Trials Safety Specialist

The Fred Hutchinson Cancer Research Center, "the Center", is a major research institution in the field of cancer study, one of only twenty-four such centers in the United States.

Major Duties and Responsibilities:

Responsibilities include develop clinical trial safety monitoring and reporting strategies for all phases of HIV Vaccine and Prevention Trials. Provide leadership in implementation of safety monitoring plans. Oversee quality control of clinical safety data. Query sites for clarification and update of clinical data. Work with SCHARP (Statistical Center for HIV/AIDS Research & Prevention) staff and site to resolve clinical queries. Oversee the design and development of tools for tracking important clinical safety events in trials. Oversee MedDra coding of all adverse experiences in all SCHARP studies. Monitor consistency reports. Work with Clinical Affairs staff to update data. Oversee the reconciliation of Serious Adverse Experience (SAE) reports with Adverse Experience data in the study database. Provide summary SAE data to investigator committee for review. Oversee the design and development of tools for SAE/AE tracking. Serve as liaison to HIV Vaccine and Prevention Trials Network partners regarding clinical safety monitoring and clinical safety data management. Review study protocols with emphasis on clinical safety monitoring; actively participate in study protocol/operations conference calls, e-mail communications and meetings. In collaboration with SCHARP staff, design and develop data collection forms, instructions and procedures. Oversee protocol safety training to ensure adherence to protocol. Oversee the development of SOPs and WPGs. Responsible for after hours coverage. Conduct all job duties within context of Good Clinical Practice (GCP) and according to SCHARP SOPs guidelines. Hire, train and supervise Clinical Affairs staff. Serve as general clinical resource for SCHARP staff by attending protocol meetings, answering clinical questions, researching special situations and providing staff training.

Requirements:

Nurse Practitioner, Physician Assistant or Medical Doctor. At least 5 years of clinical trials experience, preferably in Pharmacoviligence. Demonstrated knowledge of and experience with research methods, data quality control and data management. Previous experience overseeing clinical trial safety monitoring and clinical safety data management is highly desirable. Knowledge of GCP/ICH/FDA regulations; demonstrated effective team leadership skills; ability to communicate effectively, good organizational skills, and attention to detail.

Please refer to requisition number: NH-015570 when applying for this position.

The Fred Hutchinson Cancer Research Center and The Seattle Cancer Care Alliance are equal opportunity employers, committed to workforce diversity.

Fred Hutchinson Cancer Research Center
Reference Job Code: NH-015570

823 Yale Avenue N (J1-105)
Seattle, WA 98109
Fax: (206) 667-4051
Email: nhewitt@fhcrc.org

Fred Hutchinson Cancer Research Center is an Equal Opportunity Employer

Submitted: 07/20/2004