Senior Research Regulatory Affairs Associate

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Banner Research is currently seeking aSenior Research Regulatory Affairs Associate to provide regulatory support for facility-based research. All clinical research studies have a myriad of regulatory documents and required submissions. Failure to maintain required documentation and IRB approvals would result in non-compliance with federal regulations. As a facility-based Senior Research Regulatory Affairs Associate, you will provide regulatory support for a variety of types of projects, such as clinical trials, investigator-initiated studies, cooperative studies, chart reviews, and more.  Our portfolio includes multiple research areas, such as cardiovascular disease, orthopedics, neurology, pediatrics, pharmacy, and many others. We provide research regulatory support for many of the Banner hospitals and other facilities where research is taking place in multiple states.

As aSenior Research Regulatory Affairs Associate you will work closely with clinicians, coordinators, and other site staff while maintaining an electronic Investigator Site File for all studies. In a typical day, you may assist in making sure documents meet IRB specifications and submit to the IRB, collect and update regulatory documents, and interact with various stakeholders. Every day is different, so an interest in learning about multiple types of studies is a plus. You should be able to stay very organized while multitasking, meeting deadlines, prioritizing your workload, and feel comfortable using online and Microsoft programs. Critical thinking and attention to detail are also important. We spend most of the day on the computer and interacting with staff, clinicians, monitors/sponsors and IRBs.

Schedule: Remote Hybrid: Monday - Friday, 8am-5pm but flexible as long as during regular business hours. .

POSITION SUMMARY

This position is expected to demonstrate some degree of personal and professional competency and critical thought processes with guidance. Provides direction for the daily operational coordination for all regulatory aspects of sponsored, grant-funded and/or investigator-initiated research projects. Serves as the professional resource for regulatory information, handles the submission of electronic regulatory documents; maintains electronic site documents. Leads coordination of regulatory activities with sponsors, clinical research organizations (CROs), clinical research staff, institutional review boards (IRBs) and other internal stakeholders.

CORE FUNCTIONS
1. Prepare and submit research applications and perform regulatory study start up activities, edit informed consents and other related documents, may assist Principal Investigators (PIs) with protocol and study-related document development, facilitate completion of ongoing continuation reports to the IRB which include adverse event and protocol deviation reporting, study amendment reporting and complete other submissions to respective IRBs as required.

2.Maintain all electronic  regulatory documents including protocols, investigator brochures, consents, and recruiting materials. facilitate completion of continuing reviews and amendments per sponsor, participating institutions, Good Clinical Practice (GCP), FDA and other applicable federal, state and local regulatory agency regulations, policies and procedures, and/or guidelines.

3.Act as site’s regulatory point-person to provide information to the PI, Research Director or Clinical Trial Senior Manager, and study staff regarding IRB submissions and approvals of study-related documents. Maintain protocol status updates for pending and active projects. May participate in departmental meetings, conferences, and educational events.

4.Interact with sponsors and CROs, providing requested regulatory documents throughout the life of a study. Participate in site initiation visits, sponsor monitoring, audits and the FDA inspections for review of electronic regulatory binders. Serve as the liaison and expert regulatory representative and professional resource for assigned projects. Interact with sponsors, participating research institutions, CROs, regulatory agencies, and involved institutional departments on behalf of the PI or the IRB.

5.Coordinate regulatory activities with the needs of research staff or the IRB to ensure timely submission of all regulatory documents and requests of sponsors.

6. Maintain up-to-date knowledge on federal, state, and local research regulatory requirements. Serve as designated regulatory point-person for audits performed by regulatory agencies (i.e., OHRP, ORI, and FDA). Engage in core measures of customer service. Exhibit professional standards to ensure human subjects protection in the conduct of clinical research.

7. Perform other administrative duties as required to support the senior regulatory staff or the site’s RD or CTSM.

MINIMUM QUALIFICATIONS
Requires a bachelor’s degree in business, healthcare administration or science related field or at least two to three years of substantial and ongoing professional experience working in the research regulatory environment. In addition, an equivalent combination of education and experience may be allowed.

Must have professional designations such as Certified Clinical Research Professional (CCRP®), or Certified Clinical Research Coordinator (CCRC®) or equivalent additional years of direct research regulatory experience.

Must possess knowledge and understanding of the applicable regulatory requirements, as well as the commonly accepted concepts, practices and procedures within the research regulatory arena. In addition, must be able to use them in varied situations. Ability to plan, organize, set priorities, and work in a fast paced environment and handle multiple projects. Demonstrated capacity to problem solve, think critically and creatively, and provide assistance through a consultative role. Interpersonal skills necessary to establish and maintain effective working relationships.

Computer proficiency including, but not limited to: operational knowledge of Microsoft Office computer applications (such as MS Word, Outlook, Excel), ability to locate and synthesize information on the internet, experience working with CTMS (Complion, iRIS).

PREFERRED QUALIFICATIONS
Additional related education and/or experience preferred.

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