Research Compliance Specialist

Lehigh Valley Health Network•Allentown, PA

2d•Onsite

About The Position

Conducts research compliance tasks and initiatives such as: conducting risk assessments of various research functions, monitoring and auditing research. Conducts education and training on research related activities, regulatory change, and policies and procedures.

Requirements

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.

Nice To Haves

Bachelor’s Degree in nursing or Bachelor’s Degree health related field

Responsibilities

Conducts routine and for-cause compliance audits to ensure accuracy, privacy, and security of participant information and compliance with all protocols and relevant policies and maintains all audit records and findings.
Prepares audit reports to present to research investigators; reviews/assists in the development of research corrective and preventative action plans (CAPA), as needed.
Reviews and manages research-related compliance matters, allegations of research noncompliance, research protocol deviations, conflicts of interest related to research, and allegations of research misconduct; maintains all research compliance case records.
Assembles case documents and supportive information to present to the Research Compliance Committee (RCC) and Research Conflict of Interest Committee (COIC); writes and processes the letters of determination and management plans.
Manages a tracking system to record research conflict of interest (COI) disclosures and serves as a resource to Investigators and researchers in completing their COI Questionnaire.
Conducts research training for all new investigators and research staff to understand processes on informed consent, regulatory, source documentation, etc.
Provides education on research compliance policies, guidelines, and procedures, as needed.
Understands and remains current on relevant law, guidelines, and institutional policies to protect human subjects and ensures institutional compliance.
Demonstrates knowledge of FDA, OHRP, DHHS, GCP, Office of Research Integrity (ORI), and other regulatory agency requirements related to human subject clinical research, identifies areas of focus for quality improvement (using FDA and GCP guidelines), and ensures assures reviews are conducted in accordance with regulatory and AAHRPP requirements.