Research & Education Operations Analyst

Responsible for facilitating, reporting, and analyzing processes related to the Research Advisory Committee for the development, review, and completion of clinical research trials. This position serves as a liaison between internal customers, external customers, and the Research Advisory Committee. This position requires strong analytical and problem-solving skills as well as written and verbal communication. Advanced proficiency in Microsoft Excel and Microsoft Office Suite is required.

1.Maintain, process and route research applications, amendment forms, Interest Disclosure forms, time and effort reports, human subject protection training certificates, Clinical Research Policies, closeout forms, and supporting documents as needed.
2. Analyze and develop quarterly and ad hoc reports of Research Department services and outcomes data for presentation to the Research Advisory Committee and/or senior
management.
3. Perform complex analysis using modeling, forecasting, and statistical analysis.
4. Provide guidance to Pediatrix physicians and interdepartmental representatives in regard to the Clinical Research Policies and procedures. Assist with completion of Research Applications and related forms. Field questions from internal and external customers.
5. Review studies in queue and assess for operational needs; perform interdepartmental project coordination to reach timeline goals, as needed. Maintain communication with various departments supplying information to ensure timely completion of all research agreements.
6. Coordinate the completion of research contracts (i.e. Research Agreements, Amendments, Nondisclosure Agreements, Data Use Agreements, Investigator Agreements and any other contract type as needed) in collaboration with the Director, legal department, finance, and site/sponsor representatives as applicable.
7. Identify quality issues within the study to implement appropriate corrective action plans.  Escalate findings and action plans to appropriate parties.
8. Prepare and present project information at internal and external meetings as directed.
9. Complete annual review and/or revision of Pediatrix Clinical Research Policies.
10. Write and/or revise Standard Operating Procedures (SOPs) as directed.
11. Demonstrate strong understanding of applicable ICH Good Clinical Practice Guidelines, FDA regulations, and HIPAA regulations.
12. Coordinate administrative maintenance of the Research Advisory Committee including member roster, training status, meeting set up, record minutes, and correspondence documentation.
13. Manage the Research Application tracking database; update daily as needed.
14. Manage the Pediatrix Research and Pediatrix Research E-forms shared mailbox.

15. Track the completion of Conflict of Interest forms, Human Subjects Training, and Clinical Research Policies Training for all applicable personnel, as needed.
16. Complete special projects regarding Research and CQI Initiatives, as needed.
17. Analyze current processes and procedures, including workflow patterns, and provide input for greater efficiency and cost reductions.
18. Assist Investigators with IRB submissions by completing forms, collecting required documents, and submitting through the IRB portal.
19. Utilize ClinicalTrials.gov to submit study information and monitor for required edits as necessary.
20. Conduct biannual queries for Pediatrix affiliated publications to compile and showcase on the company website.
21. Maintain Formstack and CITI Program subscriptions and act as liaison to edit or correct forms/documents as necessary.
22. Maintain Clinical Research Department SharePoint page and RAC pages and edit website as directed.

Education required: Bachelor’s Degree
Experience required: Previous experience in Clinical Research
Skills required: Advanced Proficiency in Microsoft Excel.
Strong analytical and problem-solving skills.
Strong written and verbal communication.
Ability to work independently and with others.
Certifications preferred: Society of Clinical Research Associates Certification (SoCRA)

Benefits for Full Time employee and qualified dependents:

• Health Insurance including prescription drugs
• Dental Insurance
• Vision Insurance
• Life Insurance
• Short- and Long-Term disability options
• Employee stock purchase program – 15% discount*
• 401k with company match**
• Long Term Care (LTC)
• Pre-tax Health Savings Account (HSA)
• Pre-tax Flexible Spending Accounts (FSA)
• Aflac Hospital, Critical Illness and Accident plans
• Identity Protection
• Employee Assistance Program (EAP)

*Part Time Regular employee classifications also receive this benefit.

** Available to part-time regular and part-time casual employees age 21 and over.

Pediatrix® Medical Group, Inc. (Pediatrix) is the nation’s leading provider of physician services. Pediatrix-affiliated clinicians are committed to providing coordinated, compassionate and clinically excellent services to women, babies and children across the continuum of care, both in hospital settings and office-based practices. Specialties include obstetrics, maternal-fetal medicine and neonatology complemented by more than 20 pediatric subspecialties, as well as pediatric primary and urgent care clinics. The group’s high-quality, evidence-based care is bolstered by significant investments in research, education, quality-improvement and safety initiatives. The physician-led company was founded in 1979 as a single neonatology practice and today provides its highly specialized and often critical care services through more than 5,000 affiliated physicians and other clinicians in 37 states. 

Please Note: Fraudulent job postings/job scams are becoming increasingly common. All genuine Pediatrix job postings can be found through the Pediatrix Careers site: www.pediatrix.com/careers.

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All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.