| Research Compliance Coordinator -- Chicago, IL |
Author: Jon Merz
Date: 12-28-09 16:03
Research Compliance Coordinator – Children’s Memorial Hospital, Chicago, IL
Office of Research Integrity and Compliance.
Contact Person – Annie Munana, Director ORIC amunana@childrensmemorial.org. For additional information visit:
http://www.childrensmemorial.org/jobs
General Summary of Position Responsibility:
Under the supervision of the Director–ORIC, the primary responsibility of the Research Compliance Coordinator, (RCC), is to ensure that the various research compliance activities and programs within CMMC adhere to federal, state and local, regulations as well as institutional policy. The RCC supports the compliance committee(s) as assigned and in performing the day to day committee specific responsibilities and processes, the RCC may work under the direction and guidance of the committee manager. In addition to playing a key role in compliance this position will also promote the high ethical standards CMMC demands in all research protocol and data collection.
Essential Job Functions:
1. Assists Director in the development and maintenance of compliance programs, including but not limited to SOPs, educational/training materials, associated forms and policies, and is responsible for ensuring changes in regulatory and institutional requirements are integrated in draft SOPs and policies.
2. Conducts regulatory review of initial and continuing research protocol submissions, and amendments, for regulatory and institutional compliance with the intent of maintaining the appropriate governmental compliance. Provides a written report for the Principal Investigator and committee Chair(s).
3. Substantively interprets federal and state regulations when conducting an analysis of the research project.
4. Applies appropriate regulations and regulatory requirements by analyzing the unique fact patterns of each submission to assign the regulatory risk determinations based on the research plan, study phase and methodology. Determines the review category, per DHHS/OLAW/NIH/FDA regulations.
5. Coordinates governmental inspections and program reviews. Participates in compliance audits. Communicates with investigators, compliance committees, and appropriate parties, in written reports and correspondence the specific issues regarding non compliance.
6. Coordinates IRB/IACUC/IBC meetings attendance to ensure quorum; agenda preparation, assists in the preparation of minutes and written follow up reports and correspondence.
7. Assists in the management of data in ORIC and grant databases by data entering, tracking and monitoring pertinent submission information into the system. Provides monthly reports to the Director and Chair(s).
8. Contributes to website development, the development of quality assurance initiatives, as well as other special projects as the need arises
9. Participates in the accreditation applications, site visits and reports.
10. Attends courses and workshops, at the local and national level, for training purposes and to maintain knowledge base of current and updated regulations.
11. Other duties as assigned.
Knowledge, Skills and Abilities:
1. Bachelor’s degree required. One to three years related experience in a research compliance setting.
2. Regulatory Professional Certification or certification eligible preferred (such as CIP – Certified IRB Professional)
3. Must possess strong written and verbal communication skills, and be detailed oriented.
4. Candidate must be able to make independent decisions and function independently with minimal supervision. Candidate should be able to function with a high level of discretion and confidentiality.
5. Must possess the ability to communicate with all levels of faculty and staff within the institution in an accurate, helpful, and customer service oriented manner.
6. Must maintain current knowledge of federal, state and local regulations pertaining to the conduct of research and research compliance, such as DHHS, OHRP, FDA, OLAW, and USDA.
7. Must have working knowledge of Windows applications (Excel, MS-Office/WORD, ACCESS).
8. Maintenance of membership in a related professional organization and conference attendance is expected, such as PRIM&R.
|
|
| Topics |
Author |
Date |
  |
Research Compliance Coordinator -- Chicago, IL new |
|
Jon Merz |
12-28-09 16:03 |
|
