PRIM&R accepts advertisements from all institutions seeking to hire for positions in animal and human research ethics and related fields, such as research administration and ethics education; listing does not imply endorsement of the lister or of the qualifications stated for a position.
Job Summary: The Research Compliance Specialist will work under the direction of the Director, Office of Research Integrity to ensure compliance with federal, state, and local laws including Lehigh Valley Health Network (LVHN) hospital policies. The Research Compliance Specialist reviews and manages research related compliance matters including allegations of research noncompliance, research protocol deviations, conflicts of interest related to research, and allegations of research misconduct. This position conducts routine and for-cause compliance audits to ensure accuracy, privacy and security of participant information, and compliance with all protocols and relevant policies. Prepares audit reports to present to research investigators. Provides regulatory guidance to the LVHN research community regarding the responsible conduct of research. Conducts risk assessments of various research functions and creates a monitoring and auditing program to address areas identified by the risk assessment related to research compliance areas. Assists with the development of policies and procedures to assure compliance with all applicable federal, state, and local regulations and guidelines, and LVHN policies for clinical research. Conducts focused education and training based on findings from risk assessments and audits, regulatory changes and enforcement activities, and new policies and procedures. Coordinate reports to regulatory oversight agencies and facilitate investigations and responses to requests for information from various government entities. Reports issues related to noncompliance to the Research Compliance Committee. Coordinates data collection, review and reporting as needed to support ongoing compliance investigations. Research periodicals, internet sites, and government publications to keep abreast of federal, state, and local developments and compliance efforts related to research. Manages a tracking system to record research conflict of interest disclosures. Maintains all research compliance records. Perform other related duties and responsibility as required.
Minimum Requirements: Bachelors degree in a health field ; RN required
At least two years of experience in the clinical research environment required with at least two years of coordinating clinical trials and/or clinical trials auditing experience.
Detailed knowledge of regulations regarding the use of human subjects in clinical trials, outcomes research, nursing research, and other research areas. Experience using spreadsheet, database and word processor applications. Strong attention to detail and ability to adhere to policies and procedures is required This person must have superior organizational skills and experience exercising independent judgment and decision-making with an analytical skills set in the application of federal regulations Effective professional communication skills: Ability to communicate with others in a clear, understandable, and professional manner Strong interpersonal skill: Ability to work with personnel at all levels to gather information, communicate compliance requirements and handle complex issues within an often-sensitive political environment Ability to work collaboratively in a team environment Must be flexible and comfortable working in an uncertain and fast paced environment.
Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP); Certified in Healthcare Research Compliance (CHRC)
Licensure and Certifications: RN. Certification in related fields.
Internal Number: 5908
About Lehigh Valley Health Network
With about 18,000 employees, Lehigh Valley Health Network (LVHN) is the region’s largest employer and the health care provider of choice for more people in the region. It’s also a great place to work because our employees have A Passion for Better Medicine. They take pride in what they do, trust one another and enjoy working alongside skilled health care professionals to continue our mission to heal, comfort and care.