Job Information
Dignity Health Clinical Research Project Manager in Phoenix, Arizona
Overview
Hello humankindness (https://hellohumankindness.org/)
Located conveniently in the heart of Phoenix, Arizona, (http://phoenix.gov/visitors/index.html) St. Joseph's Hospital and Medical Center is 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 than 125 years 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 Barrow Neurological Institute (https://www.barrowneuro.org/) , Norton Thoracic Institute (https://www.dignityhealth.org/arizona/norton-thoracic-institute) , Cancer Center at St. Joseph's (https://www.dignityhealth.org/arizona/locations/stjosephs/services/university-of-arizona-cancer-center) , Ivy Brain Tumor Center (https://www.ivybraintumorcenter.org/) , and St. Joseph's Level I Trauma Center (https://www.supportstjosephs.org/traumacenter) (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 Arizona's Most Admired Companies (http://www.bestcompaniesaz.com/) .
Look for us on Facebook (http://www.facebook.com/DignityHealthStJosephsHospitalMedicalCenter) and follow us on Twitter (https://twitter.com/DignityHealthAZ) .
For the health of our community ... we are proud to be a tobacco-free campus.
Responsibilities
The Ivy Brain Tumor Center is a non-conventional, non-profit program offering state-of-the-art clinical trials for patients with the most aggressive form of brain cancer. It is home to the largest collection of Phase 0 trials for brain tumors in the world. Our multidisciplinary team of brain tumor specialists and scientists are accelerating drug discovery and precision medicine in neuro-oncology to identify the most promising first-in- class therapies for brain tumor patients.
Job Description:
The Ivy Clinical Research Project Manager is responsible and accountable for providing the coordination and leadership necessary for successful delivery of Late Phase clinical trials. 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. Demonstrated knowledge and understanding of human research policies, regulations, procedures, and standards according to FDA, ICH, GCP guidelines is required. This position interacts with a variety of stakeholders, both internal and external, requiring exceptional communication skills. The ability to multi-task and remain organized in a high-volume clinical trial setting is required.
Principal Duties and Responsibilities:
● Develop and maintain comprehensive project plans, ensuring alignment with study objectives, timelines, and budget constraints.
● Identify and mitigate potential risks through proactive risk management strategies.
● Ensure adherence to project timelines and milestones, driving the successful execution of late-phase clinical trials.
● Collaborate with internal and external stakeholders to align project activities with organizational goals..
● Collaborate with internal cross-functional teams, including clinical operations, data management, regulatory affairs, and medical affairs, to ensure seamless trial execution and communications.
● Collaborate with external partners, including Contract Research Organizations (CROs), to ensure seamless integration of their services into the overall clinical trial strategy.
● Oversee CRO selection, contracting, and management, ensuring that vendors meet quality and performance expectations.
● Conduct regular meetings with CROs to review project progress, address challenges, and optimize collaboration.
● Evaluate and negotiate contracts with vendors to ensure cost-effectiveness and adherence to budgetary constraints.
● Work closely with cross-functional teams to integrate CRO activities with internal processes, promoting efficient communication and information flow.
● Develop and manage study budgets, ensuring cost-effectiveness and adherence to financial goals.
● Optimize resource allocation for maximum efficiency in trial execution..
● Ensures proper compliance with institutional policies and procedures to ensure Ivy’s compliance with Federal, State and local laws/regulations.
● Acts as a liaison between FDA, IRB, investigators, study team and external collaborators. Act as the primary point of contact relating to project management issues.
● Maintains in-depth knowledge of frequently changing federal regulations and guidelines, and other literature related to human subject protections.
● Reviews incoming protocol amendments and revisions, identifying necessary steps for processing, and consulting with Key Stakeholders as needed.
● Identify potential risks and develop risk mitigation strategies.
● Proactively address challenges to ensure the successful progression of the clinical trial.
● Other duties as assigned.
We offer the following benefits:
Employee Assistance Program (EAP) for you and your family
Health/Dental/Vision Insurance
Flexible spending accounts
Voluntary Protection: Group Accident, Critical Illness, and Identity Theft
Adoption Assistance
Paid Time Off (PTO)
Tuition Assistance for career growth and development
Pension Plan
Matching Retirement Programs
Visit us at Ivybraintumorcenter.org , and follow us on Facebook (https://www.facebook.com/IvyBrainTumorCenter/) , Twitter (https://twitter.com/IvyBrainTumCtr) , Instagram (https://www.instagram.com/theivybraintumorcenter/?hl=en) , LinkedIn (https://www.linkedin.com/company/ivy-brain-tumor-center/) and YouTube (https://www.youtube.com/channel/UCKfECuT9bQnZ7KwQJpdsmWg)
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Qualifications
Education and Experience:
Bachelor’s degree in related field
Minimum 2 years of Project Management experience or 2 years of Clinical Research Experience. A combination of education and experience may be accepted .
Proficient to advanced computer skills; proactive strong organizational skills. Excellent verbal and written interpersonal skills.
Preferred Qualifications:
Preferred: Professional certification in research; CCRP, CCRC, or PMP.
Preferred: Experience with Microsoft Project or Smartsheet platforms.
Preferred: Experience in Global Phase 3 Trials
Master's Degree in related field preferred
Additional Requirements (e.g., two letters of recommendation): None
Pay Range
$30.55 - $44.30 /hour
We are an equal opportunity/affirmative action employer.