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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 all research compliance program policies and audit plans through risk analysis.

• Interfaces with all research departments to coordinate and monitor compliance with applicable research regulatory requirements and reports of audit results.

• Develops and implements research regulatory compliance education plans.

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

• 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 internal research complaints and reports regarding internal practices or actions which do not comply with applicable research regulations and institutional policies.

• Monitors research departments' compliance with applicable state and federal research regulatory requirements 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).
 

Position Details

Education

Bachelor's Degree- (Required)

Experience

Minimum of 1 year-Related work experience (Required)

Certification(s) and License(s)

OUR PURPOSE & VALUES: Everything we do is about caring 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 We offer healthcare benefits for full time and part time positions from day one, including vision, dental and domestic partners. Perhaps just as important, from senior management on down, we encourage an atmosphere of collaboration, cooperation and collegiality. We know that a diverse workforce with unique experiences and backgrounds makes our team stronger. Our patients, members and community come from a wide variety of backgrounds, and it takes a diverse workforce to make better health easier for all. We are proud to be an affirmative action, equal opportunity employer and all qualified applicants will receive consideration for employment regardless to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.

We are an Affirmative Action, Equal Opportunity Employer Women and Minorities are Encouraged to Apply. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of disability or their protected veteran status.

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