| Regulatory Specialist II - Clinical Trials -- Oakland, CA |
Author: Lucinda Hopewell
Date: 08-04-10 18:56
Date: 8/3/10
Title: Regulatory Specialist II-Kaiser Permanente Northern California
Job Number: 030147
Located at: Clinical Trials Compliance and Quality Department, Kaiser Foundation Research Institute - Oakland, CA
Kaiser Foundation Research Institute (KFRI) is a national program that was established in 1958 by the KaiserPermanente (KP) Health Plan/Hospitals Board of Directors to administer and support research in KP. Supporting a system of nine IRBs, KFRI holds the Federalwide Assurance for human subjects protection for all KP Regions.
The KPNC Clinical Trial Compliance and Quality Department provides a regulatory support program to assist Investigators conducting FDA-regulated clinical trials within KPNC with the preparation and maintenance of their IRB and regulatory files.
Position Summary:
THE CT Regulatory Specialist II (CTRS-II) is a position with demonstrated proficiency which, under the direction of the KPNC clinical trials administrative management and Principal Investigator, provides regulatory document support to the KPNC 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. This individual 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 full-time, exempt, position (Mon-Fri. 8:00-5:00pm) which must adhere to the position's scope of practice as outlined in the Major Responsibilities below.
Education/License/Certification:
Minimum AA degree, CIP, CIM, ACRP or SOCRA certification required. Bachelor's degree may be substituted for 1 year work experience. RAC certification will be considered.
Qualifications:
3 years effective project management experience in clinical trials research or human subjects protections required.
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 in organized fashion.
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 policies and procedures.
Summary of Major Duties:
* Assist with ensuring compliance with KPNC IRB SOPs and document applications
* Adhere to GCP, federal, state, and local regulations, and KP policies.
* Assure all site documents including SOPs and administrative files are maintained in audit-ready condition.
* Assist with internal/external audits and quality monitoring activities including monitoring visits, audits and inspections.
* Prepare, submit, and maintain required IRB documents under the direction of the PI
* Perform duties such as filing, photocopying, faxing, and distributing study-related documents.
* Create and maintain the Essential Study Binder for each IRB-approved study.
* Assist with monitoring visits from sponsor related to study specific regulatory documents
* Assist in study closure activities including scheduling monitor close-out visit, preparation and collection of close-out documentation, and preparation of study files for distribution to long-term
storage.
* Maintain long-term storage records and keep PI and "Sponsor informed of any changes in the status of study records.
* Act as liaison with internal/external parties and research team regarding regulatory document activities.
* Participate in training, education and development activities to improve own knowledge and performance to sustain and enhance professional development.
* Perform routine quality control activities and assist with quality improvement initiatives.
* Adhere to departmental policies and procedures to ensure quality, confidentiality, privacy and security of clinical research interactions and participant information, and responsible use of operational research databases in compliance with KP policies.
Interested Applicants please email: Nancy.Outenreath@kp.org with resume and cover letter for consideration or FAX to: 510-625-3748.
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