Senior Manager Clinical Trials

Banner Health

1d•Onsite

About The Position

Those who have joined the Banner mission come from all walks of life, united by the common goal: Make health care easier, so life can be better. If changing health care for the better sounds like something you want to be part of, we want to hear from you! Located in the retirement community of Sun City, Arizona and serving the Sun Cities, Surprise, Peoria, and surrounding areas, the Banner Sun Health Research Institute conducts research, clinical care, prevention and education in both memory and movement disorders. Since its founding in 1986, the work by our scientists and physicians has had a significant impact on generating ground-breaking research in these debilitating age-related diseases. The senior manager will manage the operational strategy and execution of a diverse portfolio in Phase II-IV memory clinical studies, ensuring they are compliant with protocols, ICH-GCP guidelines, and regulatory standards. Schedule: Mon-Fri 8am-4:30pm Banner Alzheimer's Institute (BAI) was established in 2006 as Banner Health's first Center of Excellence. Banner Sun Research Health Institute (BSHRI) was founded in 1986. Our team is uniquely, passionately, and strategically committed to ending Alzheimer's disease and other neurodegenerative disorders without losing another generation and to providing an unparalleled model of care for families facing this devastating disease. Banner Research is committed to improving people's lives through comprehensive patient care and advances that capitalize on the best biomedical research. We intend to make a transformational difference in Alzheimer's disease and other neurodegenerative disorders research and care. POSITION SUMMARY This position is responsible for managing research clinical trials and other studies in assigned medical service lines and/or departmental areas for medical facility based studies. Works with the Physician’s Advisory Councils (PACs) to implement research strategies that enhance organization’s ability to provide excellent patient care, attract excellent medical talent, and better serve its stakeholders. Also manages the operations of the clinical practice in order to ensure that continuous, quality, accurate, timely and cost-effective services are provided.

Requirements

Knowledge typically obtained through completion of a Bachelors degree in Biology, Nursing, or related field.
Five years of clinical research experience.
Must possess medical or bioscientific, business, and presentation skills.
Strong and demonstrable planning, management, organization, collaboration and analytical skills.
Must be able to communicate effectively with others by speaking, reading, and writing.

Nice To Haves

Regulatory knowledge of clinical research conduct and health care operations is strongly preferred.
RN license.
Additional related education and/or experience preferred.

Responsibilities

Directs personnel actions including recruiting, new hire actions, interviewing and selection of new staff, salary determinations, training, and personnel evaluations. This position also participates in the development and implementation of departmental goals and objectives in accordance with company standards. Directs the workflow for the clinical research staff.
Manages clinical research staff and individual studies (as study coordinator) in conjunction with Principal Investigators (PI) to ensure that studies are conducted in compliance with research protocol, research ethics and integrity, and in a fiscally responsible way. Ensures that sponsor requirements are completed correctly, accurately, and in a timely way. Implements strategies for research within service line and is principally responsible for carrying out those strategies.
Implements protocols for internally sponsored/investigator initiated studies, works with investigators and internal research resources to ensure statistical significance of study designs. For externally sponsored studies promotes (to sponsors) the advantages of conducting research in our medical facilities so as to attract beneficial studies.
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 and assures that they are conducted using good clinical and scientific practices and are in regulatory and policy compliance.
Collaborates with providers and managers from other departments to ensure a high quality patient experience and the highest level of patient satisfaction.
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 in designated practices.
Works with research staff, patient financial services, and financial analysts to ensure that research related charges are billed appropriately.
May provide direct patient care which includes obtaining patient medical history, systems review, phlebotomy, EKG, vital signs, and cognitive assessment on patients. Maintains quality assurance on designated protocols. Collects data as required and assists in interpreting and evaluating results as required. Triages adverse events and communicates with the research physician regarding the occurrence of adverse events. Collects information regarding indicated medical follow-up with the subject and collateral informants as needed.
This position foresees and resolves complex problems and issues. Responsibility across the assigned medical service lines and/or departments, with external contact with regulatory authorities, study sponsors, pharmaceutical sponsors, and collaborative research entities. Frequent internal contact with medical staff, hospital executives, department heads, financial and administrative staff, and patients. This position is pivotal for meeting targets for patient and employee satisfaction.