Senior Manager Oncology Clinical Trials

Posted:
12/11/2024, 5:01:10 AM

Location(s):
Maryland, United States

Experience Level(s):
Senior

Field(s):
Medical, Clinical & Veterinary

Workplace Type:
Remote

Primary City/State:

Gilbert, Arizona

Department Name:

Research

Work Shift:

Day

Job Category:

Research

A network with resources for leaders with vision.  Our leaders are at the front of the health care transformation, planning the future of Banner Health. 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 Clinical Trials Office is the oncology service line for Banner Research. The department operates in Banner MD Anderson Cancer Center and Banner Gateway Medical Center. The department conducts Phases I-III treatment clinical trials covering all disease groups with the goal to provide support to the physician investigators and to provide trial treatment options to the patients in a safe and ethical manner, while ensuring compliance to the FDA and institutional regulations.

As a Clinical Trials Senior Manager, you'll have the opportunity to combine your love of patient care with your ability to rally and motivate a team. Your team will consist of 10 direct reports; RNs, CRCs and ACRCs. Your team supports a variety of clinical trials from; Solid Tumor, Lung, Head & neck, Radiation Oncology and Breast. You play a critical role in the positive experience our patients and sponsors experience as you support the daily operations throughout the clinic and provide discretion. This is a great opportunity for someone who has prior leadership experience in clinical trials, or oncology clinical trials experience.

Schedule: 40hrs exempt, Monday - Friday 8:30am-5pm

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 286 private rooms, 13 operating suites, a 46-bed emergency department and shares a campus with the Banner MD Anderson Cancer Center. Our WIS and NICU services support an average of 4,000 deliveries per year. 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.

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 designation as a Stem Cell Transplant Center of Excellence 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 70 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.

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.

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
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/Female/Minority/Disability/Veterans

Our organization supports a drug-free work environment.

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