Research Regulatory Affairs Coordinator II

Banner Health Gilbert , AZ 85233

Posted 1 week ago

On the forefront of prevention, treatment and research, our oncology services work tirelessly for our patients dealing with all types of cancer. From detection and diagnosis to treatment and bedside care, we work to make our patients' lives better, empowering them to become cancer survivors.

Banner Research is at the leading edge in a new era of scientific discovery and innovation. Our basic and clinical research faculty turns ground-breaking research findings into new identification, treatment, and prevention methods for diseases such as:

Alzheimer's, Parkinson's, cardiovascular disease, Cancer, Fibromyalgia, Arthritis, Orthopedics, Neurological disorders. We have an international reputation for our work and we provide outstanding access for patients to clinical trials. Our commitment to excellence allows us to make a difference in people's lives every day.

This position would assist with research regulatory support within Banner Research at Banner MD Anderson Cancer Center.

Your pay and benefits (Total Rewards) are important components of your Journey at Banner Health. Banner Health offers a variety of benefit plans to help you and your family. We provide health and financial security options so you can focus on being the best at what you do and enjoying your life.

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About Banner Gateway Medical Center

Experience innovative technology and exceptional opportunities for growth and development at Banner Health's state-of-the-art hospital Banner Gateway Medical Center. With comprehensive electronic medical records, physician order entry, digital radiography and proprietary advanced patient monitoring, Banner Gateway provides you with the innovative resources you need to provide your patients with the best care possible.

Our commitment to nursing excellence has enabled us to achieve Magnet recognition by the American Nurses Credentialing Center. Located near Phoenix in Gilbert, Ariz., Banner Gateway Medical Center offers 176 private rooms, eight operating suites, a 37-bed emergency department and shares a campus with the Banner MD Anderson Cancer Center. Key specialties include oncology, obstetrics, bariatric surgery, emergency and other services that focus on meeting the changing needs of the dynamic and growing community we serve.

About Banner MD Anderson Cancer Center

Located in Gilbert, Ariz. (the Phoenix Metro area) on the Banner Gateway Campus, the center provides world-class care for oncology patients - both inpatient and outpatient - and has also brought leading oncology programs to the Banner Gateway campus including Stem Cell Transplantation and comprehensive Head & Neck cancer care. Our capabilities include five linear accelerator vaults, a brachytherapy vault, an advanced diagnostic imaging suite with PET/CT scan, more than 50 infusion bays, a cryopreservation lab and much more. Our inpatient medical oncology unit also incorporates a program that utilizes the electronic surveillance partnership in caring for the patient, where remote nurses have the ability to interact with patients via two way audio-video to assist the bedside nurse with patient care.

About Banner Health

Banner Health is one of the largest, nonprofit health care systems in the country and the leading nonprofit provider of hospital services in all the communities we serve. Throughout our network of hospitals, primary care health centers, research centers, labs, physician practices and more, our skilled and compassionate professionals use the latest technology to make health care easier, so life can be better. The many locations, career opportunities, and benefits offered at Banner Health help to make the Banner Journey unique and fulfilling for every employee.

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Job Summary

This position is expected to demonstrate a high degree of personal and professional competency, critical thought processes, and leadership with minimal guidance. Coordinates the regulatory support to physicians and clinical investigators involved in the conduct or approval of clinical research projects at the investigative site.

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 regulatory documents; maintains site source documents. Leads coordination of research activities with sponsors, clinical research organizations (CROs) clinical research staff, institutional review boards (IRBs) and other internal stakeholders.

Essential Functions

Prepare and submit research applications and perform regulatory study start up activities, edit informed consents and other related documents, assist Principal Investigators (PIs) with protocol and study-related document development, provide ongoing continuation reports to the IRB which include adverse event reporting, study amendment reporting and coordination of submissions to respective IRBs.

Develop and maintain all the sites study and regulatory documents including study amendments, recruiting material, continual reviews and safety reports 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.

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

Interact with sponsors and CROs, providing requested regulatory documents throughout the life of a study. Participate in site initiation visits for review of site regulatory binders, and during sponsor site monitoring and audit visits.

Serve as the liaison and expert regulatory representative and professional resource for any site-specific projects. Interact with sponsors, participating research institutions, CROs, regulatory agencies, and involved institutional departments on behalf of the PI or the IRB.

Coordinate daily operational activities consistent with the needs of research staff or the IRB to ensure timely submission of all regulatory documents and requests of sponsors. Distribute regulatory work load among Regulatory Affairs Coordinators I to efficiently accomplish regulatory efforts.

Maintain up-to-date knowledge on federal, state, and local research regulatory requirements. Train research staff in regulatory matters. Demonstrate support of regulatory compliance through the creation of training documents and standard operating procedures (SOPS). Provide training of research staff to assure compliance with study protocols; federal, state, sponsor, and local rules, regulations, statutes and policies.

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.

Perform other administrative duties as required to support the Regulatory Affairs Coordinator (RAC) Manager, RAC Senior Manager, or the sites RD or CTSM. Performs all functions according to established policies, procedures, regulatory and accreditation requirements; as well as applicable professional standards. Provides all customers of Banner Health with an excellent service experience by consistently demonstrating our core and leader behaviors each and every day.

Minimum Qualifications

Requires a Bachelors degree in business, healthcare administration or science related field or at least five (5) 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). A qualified candidate may be hired without current certification, but will be required to obtain such certification within the first 2 years of employment.

Must possess significant 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 fastpaced 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 electronic databases (such as iRIS, IRBNet, Click).

Preferred Qualifications

Additional related education and/or experience preferred.

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Research Regulatory Affairs Coordinator II

Banner Health