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CommonSpirit Health Project Manager in PHOENIX, Arizona

Overview

Located conveniently in the heart ofis a 571-bed, not-for-profit hospital that provides a wide range of health, social and support services. Founded in 1895 by the Sisters of Mercy, St. Joseph's was the first hospital in the Phoenix area. More than125years later, St. Joseph's remains dedicated to its mission of caring for the poor and underserved.

We are extremely proud to be a nationally recognized center for quality quaternary care, medical education and research. St. Joseph's includes the internationally renowned,,,, and(which is verified by the American College of Surgeons). The hospital is also a respected center for high-risk obstetrics, neuro-rehabilitation, orthopedics, and other medical services.St. Joseph’s is considered a sought-after destination hospital for treating the most complex cases from throughout the world. Every day, approximately 20 percent of the hospital’s patients have traveled from outside of Arizona and the United States to seek treatment at St. Joseph’s.

U.S News & World Report routinely ranks St. Joseph's among the top hospitals in the United States for neurology and neurosurgery. In addition, St. Joseph's boasts the Creighton University School of Medicine at St. Joseph's, and a strategic alliance with Phoenix Children's Hospital.

St. Joseph's is consistently named an outstanding place to work and one of Arizona's healthiest employers. Come grow your career with one of.

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For the health of our community ... we are proud to be a tobacco-free campus.

Responsibilities

Job Summary:

Project Manager will be responsible for providing oversight and leadership necessary for successful delivery of pre-clinical and clinical projects from initiation to implementation to close-out of assigned research activities. The Project Manager is expected to effectively manage scope, schedule/timelines, budget, quality and resources of the assigned trial(s). Study management will also include outside clinical site management, vendor management, and study meeting planning and execution.

Responsibilities

1.) Collaborate with project investigators and research sites to ensure targets are met for study start up, site activation, patient recruitment and enrollment

2.) Assist with clinical site contract and amendment development as applicable.

3.) Coordinate multiple studies including the review of study protocols, data and final reports

4.) Develop and collaborate on clinical documents including protocol, informed consent forms, study manuals, source documentation templates, recruitment materials and other study tools.

5.) Provides coordination and support for clinical study data management, biostatistics, and participating clinical sites.

6.) Coordinate project work activities among internal departments and stakeholders, including the biorepository and Translational Science Team.

7.) Assist in safety management and reporting to Data and Safety Monitoring Boards, medical monitors, funding and regulatory agencies.

8.) Lead cross-functional teams in the timely execution of high-quality pre-clinical and clinical research projects leveraging knowledge, expertise, and risk mitigation while functioning as the principal liaison with internal and external project stakeholders.

9.) Manage study related regulatory documents and ensure the Trial Master File (TMF) is up to date and audit ready throughout the course of the study.

10.) If applicable oversee IND and local and central IRB applications and communication with regulatory agencies (FDA,Health Canada, etc.) for studies with investigator held INDs.

11.) Assist project sites with IRB submissions, maintenance of regulatory documents and responding to study related questions from sites, vendors and sponsors in a timely fashion.

12.) Assist in database development and management, if applicable.

13.) Track key performance metrics for progress reports, help develop presentations for scientific meetings, and assist in preparing publications.

14.) Plan, manage, execute, and participate in all study team meetings both remote and in-person.

15.) Oversee quality assurance procedures for the study including the review of monitoring plans and tracking and review of trip reports.

16.) Work closely with Program Manager on project financial tracking.

17.) Take on additional tasks and responsibilities, as requested.

Qualifications

Requirements:

2 years of Project Management or 2 years of Clinical Research Experience. A combination of education and experience may be accepted.

Bachelor’s Degree in related field

Master’s Degree in related field preferred

Microsoft office package and excel experience, and Electronic Data Capture System (EDC) skill preferred

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Equal Opportunity

Dignity Health is an Equal Opportunity/ Affirmative Action employer committed to a diverse and inclusive workforce. All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, marital status, parental status, ancestry, veteran status, genetic information, or any other characteristic protected by law. For more information about your EEO rights as an applicant, please

Dignity Health will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c).

External hires must pass a post offer, pre-employment background check/drug screen. Qualified applicants with an arrest and/or conviction will be considered for employment in a manner consistent with federal and state laws, as well as applicable local ordinances, ban the box laws, including but not limited to the San Francisco and Los Angeles Fair Chance Ordinances.

If you need a reasonable accommodation for any part of the employment process, please contact us by telephone at (415) 438-5575 and let us know the nature of your request . We will only respond to messages left that involve a request for a reasonable accommodation in the application process. We will accommodate the needs of any qualified candidate who requests a reasonable accommodation under the Americans with Disabilities Act (ADA).

Dignity Health participates in E-verify.

Job ID 2020-134005

Employment Type Full Time

Department Research - ALS

Hours / Pay Period 80

Facility St Josephs Hospital and Medical Center

Shift Day

Standard Hours 08:00AM-05:00PM

Work Schedule 8 Hour

Location AZ-PHOENIX

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