Specialist, Clinical Research - Regulatory
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To assist with coordination of clinical trial regulatory activities and requirements for the Clinical Research Support Services (CRSS ) department within the Center for Health Research (CHR) and to ensure compliance with all government regulations.
- Assists with coordination of accurate quality data collection and protocol interpretation as it relates to regulatory affairs. Prepare regulatory documents, as assigned, for successful submissions to KPNWs Institutional Review Board. These may include: review requests for new protocols, amended protocols, investigative drug brochures, IND safety reports, serious adverse event reporting, annual reports, and changes to informed consents and protocol deviations/violations. Collaborate with Compliance Coordinator and study team members to clarify scientific and clinical issues. Practice according to professional, legal, and ethical standards. Collaborate in the development and implementation of systems and reports to support department and regulatory needs. Collaborate with Compliance Coordinator to evaluate systems and processes to promote effective resource utilization.
- Assist with coordination of specific regulatory assignments to support the goals of the CRSS department, Investigators, the studies and their sponsors. Prepare and submit regulatory documents to sponsors as appropriate. Ensure study administrative regulatory files are accurate and up to date. Assist in development of a quality management process within the department that includes quality control, quality assurance, and quality improvement. Communicate study-related issues, such as protocol violations and patient safety to appropriate persons. Assist with the organization of all regulatory documents and maintain the database with all pertinent regulatory information. Apply knowledge of GCP (Good Clinical Practices), HIPAA (Health Insurance Portability and Accountability Act), Institutional Review Board, and FDA (Federal Drug Administration) rules and regulations that apply to human subjects research. Anticipate fluctuations in work flow and make appropriate adjustments to meet standards and deadlines. Assist with all regulatory audits. Provide assistance with review and updates of department policies and procedures to ensure compliance with CHR/KP standards as well as government regulations.
- Foster channels of communication between research staff, PIs and KPNW Research Subject Protection Office (RSPO) to solve problems effectively. Establish positive working relationships with Principal Investigators, RSPO staff and other members of the study team to ensure timely, accurate verbal and written communication of study related regulatory activities. Provide timely, accurate communication to appropriate study team members of changes in regulatory interpretations and/or reporting requirements as required by the RSPO. Collaborate with the Research Subject Protection Office (RSPO) to ensure compliance with all institutional and regulatory requirements. Demonstrate a thorough knowledge of communication skills by contributing productively to problem solving and conflict resolution.
- Functions as a member of a multi-disciplinary team. Act as a role model, developing and participating in collaborative relationships with other staff members. Integrate the department purpose/mission/vision/values into practice. Performs other duties as requested.
- Minimum two (2) years in a clinical trial setting.
- Bachelors degree OR four (4) years of experience in a directly related field.
- High School Diploma or General Education Development (GED) required.
- Strong computer skills preferably Microsoft Word and Excel.
- Proficient in accessing and downloading information from web sites.
- Excellent written and verbal communication skills.
- Meticulous organizational and attention to detail skills.
- Ability to work well with others in various departments under pressure, and meet time deadlines.
- Flexible, able to multi-task and prioritize work.
- Working knowledge of medical terminology.
- Minimum two (2) years of research experience in clinical research setting and experience abstracting data.
- Minimum two (2) years of in clinical trial setting.
- Thorough knowledge of MS Office software and data base management.
- Knowledge of FDA regulations as they pertain to the protection of human subjects.
Kaiser Permanente is an equal opportunity employer committed to a diverse and inclusive workforce. Applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), age, sexual orientation, national origin, marital status, parental status, ancestry, disability, gender identity, veteran status, genetic information, other distinguishing characteristics of diversity and inclusion, or any other protected status. Submit Interest