| Research Compliance Administrator -- Denver, CO |
Author: Jon Merz
Date: 04-08-08 11:18
Position Summary: As a member of the Human Research Participant Protection Program (HRPPP) this individual develops, implements, directs, coordinates, and monitors programs in Research Compliance that include, but are not limited to, Research Training and Education, and Monitoring and Auditing to assure the integrity of Kaiser Permanente Colorado (KPCO) research efforts and provide a means for continual quality improvement for research conducted at this institution as well as the other essential responsibilities described below. The Research Compliance Administrator participates in an interactive network to coordinate these programs with representatives from senior leadership and throughout the different levels of the organization. The Research Compliance Administrator is responsible for assuring that appropriate programs and procedures exist to enable compliance with research regulations and to protect the rights and welfare of human research participants.
Requirements: Bachelor's degree in a health care related or bioethics field. Master's or doctoral degree preferred. At least three years experience in human research participants' protection and clinical or health services research required. Demonstrated proficiency in teaching and training adult learners. Experience conducting monitoring and auditing activities on research studies involving human participants. Demonstrated ability to interpret and apply federal regulations and organizational policies and procedures relative to research compliance, research integrity and protection of research participants. Outstanding verbal communication, written communication, teamwork, human relations, project management, problem solving and customer service skills required. Proficiency in relational databases, spreadsheets and word processing applications required.
Essential Responsibilities: Develop, implement, direct, coordinate, monitor and maintain an ongoing KPCO Research Compliance Training and Education program for all KPCO investigators and research staff to ensure compliance with federal and state regulations and institutional polices. Collaborate with research teams to develop, implement, coordinate and maintain a Monitoring and Auditing program to provide a means for continual quality improvement for KPCO research activities. Serve as resource to the Institutional Review Board & Research Review Committee of KPCO for research compliance related issues. Additional responsibilities include collaboration with the KPCO HIPAA Privacy and Security Officer to serve as the KPCO HIPAA Privacy and Security Officer for Research. Assure compliance with HIPAA Privacy and Security for KPCO research including but not limited to executing HIPAA agreements, disclosure accounting, authorization documents, and HIPAA training for researchers. Through the role Regional Research Integrity Officer, this individual will serve as research ombudsman to receive and address concerns regarding research misconduct in accordance with applicable regulations and policies. Responsible for administrating annual conflict of interest surveys for research, including maintaining a record of all survey responses, and report any appearance of a conflict to the appropriate institutional administrative bodies. Collaborate with the HRPPP Team and others as appropriate to develop and maintain Standard Operating Procedures (SOPs) and Policies and Procedures (P&Ps) for research conducted at KPCO. Prepare and disseminate written notifications to the appropriate individual, committee, regulatory body, CMPG Administration or KFHP of Colorado Administration regarding Research Compliance actions. Maintain accurate, timely complete and confidential written/computerized records that systematically track and document the decisions and operations related to compliance with federal regulations. As a member of the HRPPP Team, the Research Compliance Administrator serves as a resource to the institution for questions regarding:
• Research training and education;
• Research monitoring and auditing;
• HIPAA Privacy and Security for research;
• Research misconduct;
• Conflict of interest; and
• Current and developing regulations regarding the protection of humans research participants
Maintains and supports a culture of compliance, ethics and integrity. Maintains knowledge of policies and procedures and performs in accordance with the Principles of Responsibilities and applicable regulatory requirements, external laws and accreditation standards. Appropriately reports observed fraud or abuse.
Functional and Environmental Factors available upon request.
SCHEDULE: Mon-Fri 8:30am to 5:15pm.
Location: 10065 E. Harvard Ave Denver, CO 80231
STARTING SALARY RANGE: $56,000 - $72,000 DOE plus excellent benefits package
Qualified candidates please email resume to Lori.X.Gradwohl@kp.org referencing Research Compliance Administrator in the subject line.
- Kaiser Permanente is an AA/EEO employer -
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Author |
Date |
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Research Compliance Administrator -- Denver, CO new |
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Jon Merz |
04-08-08 11:18 |
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