Vancouver, British Columbia, Canada
Los Angeles, California
Palo Alto, California
Iowa City, Iowa
Hamilton, Ontario, Canada
Winnipeg, Manitoba, Canada
West Palm Beach, Florida
New York, New York
New Haven, Connecticut
Location: Tucson, Arizona
Type: Full Time
Internal Number: R48539
At Banner Health , we set leaders up to succeed. We ensure leaders have the staff and resources their vision requires. Join a nationally recognized leader that values excellence and begin making a difference in people's lives.
As Director of Clinical Trials at Banner Alzheimer Institute, you will be responsible for managing the needs of the research team. This is a failry new facility and we need a leader to help with the building stages of growing and expanding its research portfolio. We are looking for a dynamic leader who is action oriented, hard-working, full of energy, is comfortable in dealing with ambiguity, coping with change, shifting gears and handling risk and uncertainty. Traveling to Phoenix at designated times will be required but the position is located in Tucson, AZ. If you have 10 or more years of experience in research and are looking for a new career, apply today!
POSITION SUMMARY This position is responsible for overall operations of clinical trials at either BAI or BSHRI including management of research managers, research coordinators, research assistants, and technicians. Develops policies, procedures and strategic plans for business development and growth of clinical trials. Oversees clinical development of protocols for clinical research trials, actively participates in negotiation of trial budgets, preparation of case report forms, summaries and reports for FDA. Ensures compliance with protocols and GCPs, coordinates activities with sponsors. Serves as a knowledgeable resource about the clinical trial process and procedures and provides education for staff and investigators. CORE FUNCTIONS 1. Identifies and initiates research studies in conjunction with potential Principal Investigators (PI), Medical Directors, and Sponsors to ensure that studies meet organization's criteria for scientific or medical impact, financial sponsorship, research ethics and integrity. Develops strategies for research at BAI or BSHRI and is principally responsible for carrying out those strategies. 2. Provides input to the clinical operations portion of proposals, budgets and contracts. Partner with Finance group in development of site operating budget. Manage to final budget and forecast numbers for specific site. Ensure that appropriate cost monitoring systems are in place and that accurate project accountability is maintained. Works with research staff, patient financial services, and financial analysts to ensure that research related charges are billed appropriately. 3. Hires, trains, coaches, mentors, conducts performance evaluations, and directs the workflow for the clinical research staff. This position is also accountable for participating in the development and implementation of departmental goals and objectives. Ensures all goals and objectives are met timely and effectively. 4. Ensures the responsible conduct of research, the protection of human subject participants and that all applicable local, state and federal policies for research are followed. Facilitates clinical research studies and grants are conducted using good clinical and scientific practices and are in regulatory and policy compliance. 5. Manages the overall operations of the clinical research site in order to ensure that continuous, quality, accurate, timely and cost-effective services are provided. Collaborates with medical providers and managers from other departments to ensure a high-quality patient experience and the highest level of patient satisfaction for those participating in clinical trials. 6. Promotes the adherence to policies and procedures, standard practices of the profession, and related local, state, and federal laws. Ensures compliance for various accrediting bodies and government agencies and performs all necessary reviews, audits, education, and training to maintain compliant status. Serves as the Compliance Liaison for research related matters at designated site.
7. This position foresees and resolves highly complex problems and issues. Responsibility across the assigned departments, with external contact with regulatory authorities, study sponsors, pharmaceutical sponsors, collaborative research entities and federal/state/philanthropic granting sponsors to develop research proposals and subsequent structure and funding mechanisms. Frequent internal contact with medical staff, hospital executives, research department heads, financial and administrative staff, and patients. This position is pivotal for the compliance and development of research initiatives and in accomplishing integration of research to facility strategic plans and meeting targets for patient and employee satisfaction. MINIMUM QUALIFICATIONS
Knowledge typically obtained through completion of a Bachelors degree in Biology, Nursing, Business, medical, science or related field. Ten years of progressive and proven leadership responsibilities in a research environment. Broad knowledge of all phases of clinical research, from study startup through closeout. Knowledgeable about clinical studies involving complex trial design issues. Experience in Alzheimer's Disease and dementia. Working knowledge of cognitive instruments, particularly the ADAS-Cog, CGIC, ADL, etc. Experience working with NIH/NIA and other federal grant funding agencies. PREFERRED QUALIFICATIONS
RN or Master's degree in a related area; or equivalent combination of experience and training. Regulatory knowledge of clinical research conduct and health care operations is strongly preferred. Advanced experience in project management, including ability to multi-task and re-prioritize deliverables as necessary to meet tight timelines.
Additional related education and/or experience preferred.
What might draw you to Banner Health? A great health care career, of course—and a great place to live, no matter what stage of life you’re in. With facilities across the West, there is a health care career for everyone, from big city living in the Phoenix area to friendly small towns in the mountains and plains. As one of the largest nonprofit health systems in the country, Banner Health offers both the stability that comes with success and the possibility of exploring new areas of the country. If you’re looking to be a key contributor to a forward-looking organization, you’ll experience a wide variety of professional advantages: