Research Compliance Specialist

Lehigh Valley Health Network; United States; On-site; USD 65,000 - 90,000; Full time

Job summary

Lehigh Valley Health Network is seeking a professional to conduct research compliance tasks and initiatives, including risk assessments and monitoring of research activities. The role emphasizes education on regulatory change, policies, and procedures across the institution.

The position requires a Bachelor’s Degree and at least two years of clinical research experience, with strong knowledge of FDA, OHRP, DHHS, and GCP guidelines to ensure patient safety and data integrity.

Qualifications

• Bachelor’s Degree
• 2 years of experience in a clinical research environment
• Preferred qualifications: Bachelor’s Degree in nursing or 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.

Skills

Clinical research experience

Education

Bachelor’s Degree

Bachelor’s Degree in nursing or health-related field

Job description

Imagine a career at one of the nation’s most advanced health networks.

Be part of an exceptional health care experience. Join the inspired, passionate team at Lehigh Valley Health Network, a nationally recognized, forward-thinking organization offering plenty of opportunity to do great work.

LVHN has been ranked among the “Best Hospitals” by U.S. News & World Report for 23 consecutive years. We’re a Magnet(tm) Hospital, having been honored five times with the American Nurses Credentialing Center’s prestigious distinction for nursing excellence and quality patient outcomes in our Lehigh Valley region. Finally, Lehigh Valley Hospital - Cedar Crest, Lehigh Valley Hospital - Muhlenberg, Lehigh Valley Hospital- Hazleton, and Lehigh Valley Hospital - Pocono each received an ‘A’ grade on the Hospital Safety Grade from The Leapfrog Group in 2020, the highest grade in patient safety. These recognitions highlight LVHN’s commitment to teamwork, compassion, and technology with an unrelenting focus on delivering the best health care possible every day.

Whether you’re considering your next career move or your first, you should consider Lehigh Valley Health Network.

Summary

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.

Job Duties

• 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.

Minimum Qualifications

• Bachelor’s Degree
• 2 years of experience in a clinical research environment

  Preferred Qualifications

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

  Physical Demands

  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.

  Job Description Disclaimer: This position description provides the major duties/responsibilities, requirements and working conditions for the position. It is intended to be an accurate reflection of the current position, however management reserves the right to revise or change as necessary to meet organizational needs. Other responsibilities may be assigned when circumstances require.

  Lehigh Valley Health Network is an equal opportunity employer. In accordance with, and where applicable, in addition to federal, state and local employment regulations, Lehigh Valley Health Network will provide employment opportunities to all persons without regard to race, color, religion, sex, age, national origin, sexual orientation, gender identity, disability or other such protected classes as may be defined by law. All personnel actions and programs will adhere to this policy. Personnel actions and programs include, but are not limited to recruitment, selection, hiring, transfers, promotions, terminations, compensation, benefits, educational programs and/or social activities.

  https://youtu.be/GD67a9hIXUY

  Lehigh Valley Health Network does not accept unsolicited agency resumes. Agencies should not forward resumes to our job aliases, our employees or any other organization location. Lehigh Valley Health Network is not responsible for any agency fees related to unsolicited resumes.

  Work Shift:

  Day Shift

  Address:

  1255 S Cedar Crest Blvd

  Primary Location:

  Allentown- 1255 Cedar Crest

  Position Type:

  Onsite

  Union:

  Not Applicable

  Work Schedule:

  Monday -Friday: 8:00am-4:30pm

  Department:

  1004-13000 COH-Institutional Review Board