| Regulatory and Administrative Specialist -- San Rafael, CA |
Author: Karin Ludwig
Date: 06-21-11 18:16
REGULATORY AND ADMINISTRATIVE SPECIALIST – CONTRACTOR POSITION
IMMEDIATE AVAILABILITY
Contact: Ms Lea Ann Bernick, Program Manager 415-760-1741
Sutter Health Western Cancer Division
Cancer Research Group
Terra Linda Health Plaza
4000 Civic Center Drive
San Rafael, CA 94903
POSITION SUMMARY:
The incumbent is responsible and accountable for ensuring all protocol related regulatory processes and procedures are maintained for both new and existing cancer research clinical trials. The incumbent drafts all relevant IRB (Institutional Review Board) and NCI cooperative group submission documentation in a timely manner. Prepares annual continuing review reports for all protocols and ensures they are submitted by the required due date. The incumbent is also responsible for downloading all protocol amendments, notices, suspensions, terminations, advertisements, and internal and external safety reports (adverse reaction reports) to and preparing them for submission. These same documents must be distributed to physician investigator for review and loaded when appropriate onto intranet collaboration website for medical centers to access. The incumbent is accountable for maintaining and keeping program regulatory files current, and maintaining all databases and tracking systems in place for these activities. The incumbent will provide rounding of quality assurance chart reviews at each medical center on a quarterly basis as part of the QA program. The incumbent will Administrative support will include: maintenance of investigator membership files and updates; distribution of all IRB approved documents to 4-5 medical centers; and other assigned support from other Program Manager;.
REPORTING RELATIONSHIPS:
This position reports to the Program Manager.
MINIMUM POSITION REQUIREMENTS:
• Education:
• Bachelor of Arts degree in business or a health related field or equivalent work experience is required.
• Experience in healthcare, business English, administrative systems, computers is essential.
• Experience in Institutional Review Board requirements and research is preferred.
• Experience:
• Demonstrated abilities to professionally handle public contact, confidential information and maintain effective work flow, and filing/tracking systems are required.
• Experience in word processing and database software (Excel) are required.
• Prior experience coordinating and processing documents for an Institutional Review Board is preferred.
• Prior experience ensuring compliance with research regulations is preferred.
• Knowledge:
• General knowledge of clinical research is required;
• Knowledge of oncology terminology, disease process and treatments is preferred.
• Knowledge and understanding of governmental regulations concerning research involving human subjects, including those of the U.S. Food and Drug Administration (FDA), Office for Protection of Research Subjects, and National Cancer Institute (NCI), is preferred.
• Special Skills/Equipment:
• Ability to manage multiple tasks simultaneously and work is required.
• Excellent interpersonal and communications skills, both oral and written are essential.
• Proficiency in Microsoft for Windows including: Word 6.0 (table production and manipulation) is required. Proficiency in Excel software is required. Access database software is preferred.
• Well developed organizational skills, systemization of work flow processes and ability to follow-through with detailed processes and procedures within designated time frames is required.
• Ability to work with minimal supervision.
• Physical Requirements:
• Must be able to walk carrying up to 20 pounds of office supplies or patient medical records, documentation from copy center.
• Must be able to sit for extended periods of time for computer work.
QUANTIFIABLE DIMENSIONS:
This position supports the Sutter Western Division Cancer Research Group in facilitating the institutional review process and maintenance of required federal documents required for continued participation in NCI- and FDA-approved research protocols. This position is required to collect and maintain information, systems and documents for investigator and facilities affiliated with the Research Program for the conduct of approximately 30-40 clinical trial protocols per year, and 40 protocols in long term follow up. Provides back up support for Program Manager when on leave or at outside meetings.
FREEDOM TO ACT/ACCOUNTABILITY:
The Research Regulatory and Administrative Specialist has the authority to review and process sensitive and confidential information, initiate SHWDCRG protocol related activities for approved studies, to order supplies in accordance with budgetary constraints, maintain and upgrade multiple tracking systems, and prepare documentation for Program Manager sign off. The incumbent is expected to work independently and balance priorities upon receipt of project direction and prioritization from the Program Manager. The incumbent is expected to be able to work independently with minimal supervision and strict accountability to maintain regular tasks and assignments.
HIPAA:
This position has access to protected health information. The protected health information this position can access is all medical information. This position requires this patient health information in order to perform the functions outlined as part of this position description.
WORKING RELATIONSHIPS/CONTACTS:
Principal contacts are the Research Manager, IRB Specialist, Clinical Research Associates, and NCI-affiliated research bases and study sponsors.
|
|
|
