Research Regulatory Coordinator at The Cancer &… · Grand…

Our Mission: At The Cancer & Hematology Centers we are dedicated to help, healing and hope for cancer patients and their families.

We provide our patients with advanced treatments, innovative research and, above all else, compassionate care. Our patients receive the most comprehensive, contemporary cancer care balanced with the compassion of a dedicated nursing and support staff. Treating cancer requires a team of committed and caring health care professionals working together to understand and address your needs. In addition to caring physicians, we have a full range of support staff available to assist you and your family, such as oncology-certified nurses, social workers, experienced lab and pharmacy personnel and a psychologist. Our focus is not just on healing but also on helping and offering hope. We know that being diagnosed with cancer is a life-changing event, and it takes a lot of adjustment to accept the emotional and physical realities of this disease. Our staff understands what you’re going through and can offer compassion and resources to help. To us, it’s important that healing isn't just centered on your disease site. Our cutting-edge cancer care is available close to home. Our medical staff have close ties to prominent hospitals and ongoing cancer research, and we bring those breakthrough advances to our regional centers to progress the level of care that is offered right here at home. 

Why Join Us? We are looking for talented and high-motivated individuals who demonstrate a natural desire to support the meaningful work of community oncologists and the patients we serve.

Job Description:

Desired/Required Qualifications:

Education:

• Bachelor’s degree or equivalent in related field required.

• Education may only be substituted with an equivalent number of years (4+) of experience directly related to Clinical Research Regulatory Affairs, or clinical training programs such as MA or LPN.

Specific skills & abilities:

• Two years of experience in Clinical Research, with preference for experience in Research Regulatory Affairs or agencies such as the FDA, IRBs or IBCs.

• Completion of a research-related certification such as SOCRA, CRPM, or similar, is preferred.

• Experience with eRegulatory systems, Electronic Medical Records, CTMS, Electronic Data Capture, Microsoft Office Suite preferred.

• Strong communication skills in person and virtually.

• Strong organizational skills and attention to detail required.

Primary Duties and Responsibilities

1. Prepare electronic regulatory file folders

2. Prepare initial regulatory packet to Sponsor (EMR/SDIL Checklists, Delegation Log template, FDA 1572, Financial Disclosure forms, Central Documents, SOPs, etc.).

3. Complete and obtain signatures on Protocols, Amendments and Investigator’s Brochures from appropriate personnel.

4. Maintain central documentation, including Curriculum Vitae, Medical Licenses, Good Clinical Practice certification, Human Subject Research certification, lab normal ranges, CLIA, etc. with assistance from the Research Assistant.

5. Complete and maintain Financial Disclosure forms and FDA Form 1572 for all studies.

6. Complete and maintain Delegation of Authority Logs.

7. Review Site Initiation Visit binders provided by Sponsors and distribute documents to appropriate personnel.

8. Prepare and submit IRB submissions, manage IRB correspondence, and distribute IRB-approved documents to appropriate staff for new and existing studies.

9. Prepare forms and submissions for IBC review, as applicable.

10. Review and edit Informed Consent documents to match site SOPs and budget and contracts prior to IRB submission.

11. Track IRB required dates for reviews and amendments, and complete IRB Continuing Reviews as needed.

12. Process IND Safety reports, SUSAR reports and other interim safety reports per SOP.

13. Prepare for monitor visits by ensuring that the regulatory binder is complete, monitors have access to the eBinder system, and be available for same-day questions, as well as follow-up items.

14. Attend internal meetings surrounding Severe Adverse Events (SAEs) and Protocol Deviations (PDs) to provide guidance on IRB-reportability and file the surrounding documentation to the regulatory binder as well as report to the IRB if necessary.

15. Distribute protocol-specific training documents and create/maintain training logs for all required documentation.

16. Update internal spreadsheets, project management software, online systems, etc. as needed with information about regulatory status and billable regulatory tasks.

17. Contribute to departmental projects for addition of research sites, migration to new electronic systems, and other projects as necessary.

18. Maintain consistent communication with sponsors and internal research staff to ensure efficient delivery and maintenance of regulatory documentation.

19. Filing of all study-related communications and documentation.

20. Assist in sponsor, FDA, or internal quality assurance audits of regulatory documentation, and the follow-up task resolution.

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.