Job Summary

The Research Compliance Analyst will work with the leaders of Research and other stakeholders in the system to help research and develop the necessary policies and education programs to address risk areas. Responsible for independently conducting directed and scheduled audits of research studies and related activity. Coordinates and provides educational programming to research faculty and staff. Responsible for executing central administrative duties associated with the Office of Research Compliance. Through these audits and responsibilities, will help identify areas of compliance vulnerability and risk.

Job Duties

• Responsible for preparation of materials for research compliance committee meetings.

• Assists with development,implementation, and maintenance of allresearchcompliance program policies and audit plans through risk analysis.

• Interfaces with allresearchdepartments to coordinate and monitor compliance withapplicable research regulatory requirements and reports of audit results.

• Develops and implementsresearchregulatory compliance education plans.

• Assists with development of research auditing and review processes, and independently carries out these audits and processes to monitor compliance with applicableresearchregulations.

• Conducts appropriate Medicare Coverage Analysis review process to ensure institutional compliance with CMS billing requirements.

• Conducts review of conflict of interest disclosures for research investigators, organizes and presents disclosures to Research Conflict of Interest Committee, assists in creating conflict of interest management plans, and monitors compliance with internal conflict of interest policy.

• Responsible for administrative oversight and training for ClinicalTrials.gov registration.

• Conducts review of electronic files when a researcher terminates Geisinger employment to ensure data transfer is appropriate.

• Assists with development, implementation, and maintenance of an investigation and remediation process to ensure prompt response to, and investigation of, any potential research non-compliance or misconduct that is inconsistent with applicable research regulatory requirements.

• Assists with ensuring implementation and maintenance of a formal system to receive and record internalresearchcomplaints and reports regarding internal practices or actions which do not comply with applicableresearchregulations and institutional policies.

• Monitorsresearchdepartments' compliance with applicable state and federalresearchregulatoryrequirements regarding record retention.

• Demonstrates comprehension and understanding of federal regulations and guidelines of the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Good Clinical Practice Guidelines (GCP), and the International Conference on Harmonization (ICH); and seeks knowledge growth of aforementioned regulations.

Work is typically performed in an office environment. Accountable for satisfying all job specific obligations and complying with all organization policies and procedures. The specific statements in this profile are not intended to be all-inclusive. They represent typical elements considered necessary to successfully perform the job.

*Relevant experience may be a combination of related work experience and degree obtained (Associate’s Degree = 2 years; Bachelor’s Degree = 4 years).

Education

Bachelor's Degree- (Required)

Experience

Minimum of 1 year-Related work experience (Required)

About Geisinger

Founded more than 100 years ago by Abigail Geisinger, the system now includes ten hospital campuses, a 550,000-member health plan, two research centers and the Geisinger Commonwealth School of Medicine. With nearly 24,000 employees and more than 1,700 employed physicians, Geisinger boosts its hometown economies in Pennsylvania by billions of dollars annually. Learn more at geisinger.org or connect with us on Facebook, Instagram, LinkedIn and Twitter.

Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected category under applicable federal, state, and local laws.

Our Vision & Values

Everything we do is about making better health easier for our patients, our members, our students, our Geisinger family and our communities.

KINDNESS: We strive to treat everyone as we would hope to be treated ourselves.

EXCELLENCE: We treasure colleagues who humbly strive for excellence.

LEARNING: We share our knowledge with the best and brightest to better prepare the caregivers for tomorrow.

INNOVATION: We constantly seek new and better ways to care for our patients, our members, our community, and the nation.

SAFETY: We provide a safe environment for our patients and members and the Geisinger family.

Our Benefits

We offer healthcare benefits for full time and part time positions from day one, including vision, dental and prescription coverage.