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Clinical Trials Regulatory Specialist II(258184)

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Company: Kaiser Permanente

Location: Pasadena, CA

Date Posted: July 3, 2014

Source: Kaiser Permanente

Description

The Clinical Trial Regulatory Specialist II (CTRS-II) is a position with demonstrated proficiency which, under the direction of the KPSC clinical trials administrative management or designee and Principal Investigator (PI), provides regulatory document support to the Kaiser Permanente Southern California (KPSC) PI and research site(s) conducting multiple FDA-regulated or other clinical trials. The CTRS-II has demonstrated proficiency in providing operational support for Sponsor and IRB regulatory compliance. The CTRSII works independently and assumes increased responsibilities. This position is also responsible for assisting in protecting the health, safety, and welfare of research participants. This is a non-licensed position which must adhere to the position's scope of practice as outlined in the Major Responsibilities below.

Essential Functions:

• Compliance:
• Support and comply with the Principles of Responsibility (Kaiser Permanente Code of Conduct).
• With guidance from PI and KPSC Clinical Trials Compliance Director, assist with ensuring compliance with KPSC IRB Standard ...

Description

The Clinical Trial Regulatory Specialist II (CTRS-II) is a position with demonstrated proficiency which, under the direction of the KPSC clinical trials administrative management or designee and Principal Investigator (PI), provides regulatory document support to the Kaiser Permanente Southern California (KPSC) PI and research site(s) conducting multiple FDA-regulated or other clinical trials. The CTRS-II has demonstrated proficiency in providing operational support for Sponsor and IRB regulatory compliance. The CTRSII works independently and assumes increased responsibilities. This position is also responsible for assisting in protecting the health, safety, and welfare of research participants. This is a non-licensed position which must adhere to the position's scope of practice as outlined in the Major Responsibilities below.

Essential Functions:

• Compliance:
• Support and comply with the Principles of Responsibility (Kaiser Permanente Code of Conduct).
• With guidance from PI and KPSC Clinical Trials Compliance Director, assist with ensuring compliance with KPSC IRB Standard Operating Procedures (SOP) and document applications.
• Adhere to Guideline for Good Clinical Practice (GCP), federal, state, and local regulations, and KP policies and procedures.
• Assure all site documents including SOPs and administrative files are maintained in audit-ready condition.
• Assist with internal and external audits and quality assurance activities including monitoring visits, audits and inspections.
• Support the cost effective financial aspects of the clinical trial.
• Study Implementation:
• Prepare the following IRB documents: a. New protocol applications; b. KP consent form draft; c. Protocol modification forms; d. Adverse Event/Serious Adverse Event summary for annual report; and e. IND Safety Report Summary sheet for annual report.
• Assist the PI and other designated research staff in the preparation, submission, and maintenance of the following study-related regulatory documents: a. Current and obsolete versions of protocol and consent forms; b. FDA form 1572 and/or 1571; c. Protocol violations/deviations; d. Serious adverse events; e. Current and obsolete Investigation Drug Brochures; f. Documentation of IRB submissions and related correspondence, reports, and letters; g. Current laboratory certifications and normal reference ranges; h. Research staff CVs and licenses, training materials, and certifications; and i. Test article accountability forms, signature logs, etc.
• Perform duties such as filing, photocopying, faxing, and distributing study-related documents.
• With direction from PI, assist in preparation of annual, interim and final KPSC IRB reports.
• Maintain current licensure documentation including MD/RN licenses and CVs.
• Maintain training and education documentation for research personnel.
• Obtain regulatory certifications including KP laboratory state licenses, current laboratory certifications and normal reference ranges.
• With direction from PI, communicate and coordinate with the Sponsor regarding study document regulatory file on activities and functions, including scheduling and conducting Sponsor-initiated monitor visits and following-up on outstanding items.
• Coordinate with the PI and internal/external parties regarding the collection and maintenance of regulatory IRB and other documentation and procedures.
• Perform data entry of study activities into a database program to track pertinent study activity (i.e., study enrollment, consents, protocol violations/deviations, serious adverse event reports, and IRB history).
• This job description is not all encompassing.

Qualifications

Basic Qualifications:

Experience
• Minimum three (3) years effective project management experience in clinical trials research or human subject"s protections required.
• Bachelor's degree may be substituted for one (1) year work experience.
Education
• Associate's degree required, OR two (2) years of experience in a directly related field.
• High School Diploma or General Education Development (GED) required.
License, Certification, Registration
• CIP, CIM, ACRP or SOCRA certification required.

Additional Requirements:
• Must be proficient in electronic health systems and databases used in research environment, word-processing and spreadsheets.
• Demonstrate proficiency in medical terminology.
• Demonstrate written, verbal, and interpersonal communication skills.
• Attention to detail and accuracy.
• Ability to effectively manage multiple tasks with strict timelines.
• Demonstrate prioritization and organizational skills.
• Ability to address issues with problem solving skills.
• Ability to be flexible and dependable.
• Ability to work effectively on cross-functional teams.
• Present professional manner and appearance.
• Comprehensive knowledge of the principles, methods and procedures of basic medical and/or clinical research processes.
• Comprehensive knowledge and understanding of human research protection regulations, policies, procedures, and standards as
applied to IRB and compliance operations.
• Comprehensive knowledge of GCP, federal, state, and local regulations including HIPAA and KP policies and procedures.
• Must be able to work in a Labor/Management Partnership environment.

Preferred Qualifications:
• RAC certification will be considered.

Primary Location
: California-Pasadena-S. Los Robles Administration 100 S. Los Robles Scheduled Hours (1-40): 40 Shift: Day Working Days: Mon, Tue, Wed, Thu, Fri Working Hours Start: 8:00 AM Working Hours End: 5:00 PM

Schedule
: Full-time

Job Type
: Standard

Employee Status
: Regular Employee Group: Salaried Employees

Job Level
: Individual Contributor

Job
: Research and Development Public Department Name: Research and Evaluation

Travel
: No Job Eligible for Benefits: Yes

External hires must pass a background check/drug screen. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.

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