Research Regulatory Coordinator

OneOncology•Grand Rapids, MI

21h

About The Position

The Cancer & Hematology Centers is seeking a talented and highly motivated Regulatory Coordinator to support the meaningful work of community oncologists and the patients they serve. This role is crucial in ensuring that all regulatory documentation is prepared, maintained, and submitted accurately and efficiently for clinical research studies. The center is dedicated to providing advanced treatments, innovative research, and compassionate care to cancer patients and their families, bringing cutting-edge cancer care close to home.

Requirements

Bachelor’s degree or equivalent in related field required.
Two years of experience in Clinical Research, with preference for experience in Research Regulatory Affairs or agencies such as the FDA, IRBs or IBCs.
Strong communication skills in person and virtually.
Strong organizational skills and attention to detail required.

Nice To Haves

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.
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.

Responsibilities

Prepare electronic regulatory file folders.
Prepare initial regulatory packet to Sponsor (EMR/SDIL Checklists, Delegation Log template, FDA 1572, Financial Disclosure forms, Central Documents, SOPs, etc.).
Complete and obtain signatures on Protocols, Amendments and Investigator’s Brochures from appropriate personnel.
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.
Complete and maintain Financial Disclosure forms and FDA Form 1572 for all studies.
Complete and maintain Delegation of Authority Logs.
Review Site Initiation Visit binders provided by Sponsors and distribute documents to appropriate personnel.
Prepare and submit IRB submissions, manage IRB correspondence, and distribute IRB-approved documents to appropriate staff for new and existing studies.
Prepare forms and submissions for IBC review, as applicable.
Review and edit Informed Consent documents to match site SOPs and budget and contracts prior to IRB submission.
Track IRB required dates for reviews and amendments, and complete IRB Continuing Reviews as needed.
Process IND Safety reports, SUSAR reports and other interim safety reports per SOP.
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.
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.
Distribute protocol-specific training documents and create/maintain training logs for all required documentation.
Update internal spreadsheets, project management software, online systems, etc. as needed with information about regulatory status and billable regulatory tasks.
Contribute to departmental projects for addition of research sites, migration to new electronic systems, and other projects as necessary.
Maintain consistent communication with sponsors and internal research staff to ensure efficient delivery and maintenance of regulatory documentation.
Filing of all study-related communications and documentation.
Assist in sponsor, FDA, or internal quality assurance audits of regulatory documentation, and the follow-up task resolution.