| Quality Improvement Consultant (Clinical Research) -- Boston, MA |
Author: Jon Merz
Date: 10-25-11 15:55
Title: Quality Improvement Consultant (Clinical Research)
Institution: Children's Hospital, Boston
EQuIP/Clinical Investigations
Status: Full-time, 40-hrs/week
Under the supervision of the Manger for the Education and Quality Improvement Program (EQuIP), the Quality Improvement (QI) Consultant will be responsible to:
- Perform internal, on-site QI review activities (preparation, conduct and close-out report) of on-going clinical research studies to evaluate and assess current practices.
- During QI reviews, identify areas of non-compliance, communicate findings and as possible, provide guidance and recommendations for developing corrective and preventative actions.
- Develop and provide educational tools and trainings aimed to facilitate compliant research practices in accordance with institutional policies and applicable federal and state regulations and good clinical practices (ICH-GCP, HHS, FDA); as well as to support institutional quality improvement initiatives.
- Provide one-and-one trainings and group presentations aimed to educate and update the research community (New PI orientation, Research Coordinator Orientation)
- Serve as an educational resource for the clinical research community as to improve clinical research record keeping, conduct and procedures to be in compliance with accreditation and regulatory requirements.
Qualifications:
Minimum educational requirements include a RN, BSN, BS, MS, or BA degree or equivalent in a scientific or health care field.
2-4 years experience in a clinical research setting, preferably as a clinical research coordinator/nurse, in an IRB or research compliance office. Prior experience as clinical research monitor/associate (CRA) for FDA regulated trials a plus.
Knowledge research regulations regarding human subject protections (HHS 45 CFR 46; FDA 21 CFR parts 50, 54, 312 and 812) and good clinical practices (ICH -GCP) is desirable. Knowledge of sponsor-investigator responsibilities for IND and IDE-holders, and applicable FDA regulations is a plus.
Qualified candidates must have excellent organizational, presentational, written and verbal communication skills as this position requires frequent interaction with many Principal Investigators and research staff. Exceptional interpersonal skills required. Candidates must be open-minded, adaptable to evolving assumptions/interpretations and creative in developing and implementing new QI initiatives. Candidates must exercise sound judgment and work with confidential information. Candidates must have the ability to multitask, adapt to changing priorities, and work under pressure, both independently and collaboratively as part of a team.
If interested, please send resume and cover letter to Eunice Newbert via email: eunice.newbert@childrens.harvard.edu.
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Author |
Date |
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Quality Improvement Consultant (Clinical Research) -- Boston, MA |
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Jon Merz |
10-25-11 15:55 |
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