Research Regulatory Coordinator

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* Location:

** Fort Wayne Medical Oncology and Hematology
** Pay Range:**$23.85 - $41.96#
** Job Description

Summary:

**# Research Regulatory Coordinator is responsible for collaborating with the PI’s and internal and external members of the clinical research team within scope of clinical trial regulatory submission and compliance. Assist in preparing regulatory submissions and maintaining the regulatory files. Coordinate the preparation of regulatory documents for submission to the Institutional Review Board (IRB) or other IRB’s as determined, other internal committees and the FDA as necessary including but not limited to:
Initial documents submission;
Continuing Reports;
Amendments and addendums to research protocols and consent documents and Adverse Event reporting. Collaborate with study team members to perform these duties. Assist in maintaining master regulatory files in accordance with institutional, state and federal regulations.

Demonstrates working knowledge of all facets of role, relevant regulations, and organizational and departmental policies and procedures.  Performs other duties and projects as assigned. Performs all duties in accordance with regulatory requirements and organizational policies and procedures.#
** Primary Key Performance Areas:**#
*** KPA 1 – Creates and maintains central regulatory files in accordance with site SOP.
**** Adhere to and maintain working knowledge of  practice policies, the Federal regulations, ICH, and GCP guidelines.
* In compliance with the Code of Federal Regulations under the Health Insurance Portability and Accountability Act (HIPAA), assure that patient records will be kept confidential and secure.
* Maintain the investigative site study files and regulatory binders.
* Responsible for the preparation of archiving closed studies for long-term storage
* Collect and maintain study specific documentation (for main and satellite locations as needed) in the appropriate Regulatory Binder as well as the electronic document system including:  + Create and maintain the Research Delegation of Authority logs and role specific profiles, ensure revised profiles to investigators and research staff as roles and responsibilities necessitate.  + Create and maintain study-specific FDA Form 1572, ensure form is reconciled and updated as change necessitates.  

+ Collect and maintain Financial Disclosure Forms as completed by investigators, escalate reported disclosures to leadership if reported.  + In collaboration with various departments, maintain historical credentials all current and previous Investigators and research staff, laboratory licenses, CLIA/COLA. Produce as needed for Sponsor/CRO review.
* Maintain credible documentation by using ALCOAC method (Attributable, Legible, Contemporaneous, Original, Accurate, Complete).
* Support GCP and protocol specific training for staff and investigators by:  + Upload and archive protocol specific training modules for all studies.  + According to site SOP, distribute training module assignments and maintain documentation GCP training for all research staff and investigators.
*** KPA 2 – Ensure completion, submission and subsequent distribution of IRB approved documents in accordance with site SOP.
**** Process regulatory documents:  initial submission, ongoing required documents for each study, continuing review, study closure procedures in accordance with GCP, ICH/FDA requirements.
* Process IND safety reports.
* Prepare and ensure timely reporting and submissions to IRB in accordance to site SOP and federal regulations including:  + Initial IRB submission and approval is obtained at study activation and maintained in the Regulatory Binder  + Obtain documentation of IRB approvals, including amendments and revision to study related documents, such as revised informed consents and protocols and maintain in the Regulatory Binder.  

+ Complete the IRB Continuing review reports required by the IRB and submit to the applicable IRB. File all correspondence regarding continuing review report submission in the Regulatory Binder.  + Ensure the process is followed for reporting any Serious Adverse Event (SAE) to the IRB that meets IRB…