Research Compliance Specialist
On-siteAllentown, Pennsylvania, United States
Job Summary
Conduct research compliance tasks including risk assessments, monitoring, and auditing of various research functions. Perform routine and for-cause compliance audits to ensure accuracy, privacy, and security of participant information, then prepare audit reports and corrective action plans. Manage research-related compliance matters, allegations of noncompliance, protocol deviations, and conflicts of interest while maintaining case records and processing committee letters. Conduct education and training for new investigators and staff on informed consent, regulatory guidelines, and source documentation. Work Monday through Friday from 8:00am to 4:30pm at Lehigh Valley Health Network in Allentown.
Required Qualifications
- Bachelor's Degree
- 2 years of experience in a clinical research environment
- Ability to work with personnel at all levels to gather information, communicate compliance requirements, and handle complex issues
- Knowledge of regulations regarding the use of human subjects in clinical trials, outcomes research, nursing research, and other research areas
- Strong attention to detail and ability to adhere to policies and procedures
- Lift and carry 25 lbs
- frequent sitting/standing
- frequent keyboard use
- patient care providers may be required to perform activities specific to their role including kneeling, bending, squatting and performing CPR
Desired Qualifications
- Bachelor's Degree in nursing or Bachelor's Degree health related field
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