Clinical Trials Senior Manager non cellular therapy Hematology

Primary City/State:

Gilbert, Arizona

Department Name:

BMDACC Gateway Oncology-Rsrch

Work Shift:

Day

Job Category:

Research

Health care is constantly changing, and at Banner Health, we are at the front of that change. We are leading health care to make the experience the best it can be. We want to change the lives of those in our care – and the people who choose to take on this challenge. If changing health care for the better sounds like something you want to be part of, we want to hear from you.

 

Banner MD Anderson Cancer Center combines the expertise of Banner Health, one of the country’s largest nonprofit hospital systems, with the internationally renowned MD Anderson Cancer Center. We provide the quality care of MD Anderson to Arizona patients, ensuring they benefit from top-tier cancer treatment close to home. Our center offers a warm, personalized experience while providing access to MD Anderson trials and innovative therapies.

 

This role provides leadership and operational oversight for oncology clinical trial activities across  at Banner MD Anderson Gateway and affiliated satellite sites. On a day-to-day basis, the Senior Manager will oversee research management staff, support protocol execution and regulatory compliance, and serve as an escalation point for operational or staffing issues. The role includes close partnership with investigators, physicians, sponsors, and central research support teams, as well as involvement in study start-up, enrollment oversight, and ongoing trial management. A key focus of this position will be guiding teams through a period of structural reorganization, standardizing workflows, strengthening communication, and supporting staff development and performance.

 

Location: BMDACC at Canyon Springs (2940 E Banner Gateway Dr)

Schedule/Shift: M-F normal business hours, no weekends required

Banner Alzheimer's Institute (BAI) was established in 2006 as Banner Health's first Center of Excellence. Banner Sun Health Research 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, advancing oncology research to improve cancer prevention and treatment outcomes, and providing an unparalleled model of care for families facing these devastating diseases. 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, other neurodegenerative disorders, and oncology 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.

CORE FUNCTIONS
1. 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.

2. 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.

3. 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.

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 and assures that they are conducted using good clinical and scientific practices and are in regulatory and policy compliance.

5. Collaborates with providers and managers from other departments to ensure a high quality patient experience and the highest level of patient satisfaction.

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 in designated practices.

7. Works with research staff, patient financial services, and financial analysts to ensure that research related charges are billed appropriately.

8. 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.

9. 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.


MINIMUM QUALIFICATIONS
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.

PREFERRED QUALIFICATIONS
Regulatory knowledge of clinical research conduct and health care operations is strongly preferred. RN license.

Additional related education and/or experience preferred.

EEO Statement:

EEO/Disabled/Veterans

Our organization supports a drug-free work environment.

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