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Project Manager Clinical Research Regulatory
3 months ago
Overview:
Hello humankindness
Looking for career growth opportunities? Join the Barrow Neurological Research Team as a Clinical Research Regulatory Project Manager
This position will be responsible for steering the regulatory affairs of a groundbreaking multi-center clinical study in translational ALS research. Join forces with a dynamic team collaborating with world-renowned leaders in ALS biomarker and clinical research. Bring your strong interpersonal and organizational skills to the forefront as you oversee the Trial Master File and contribute to ICF and protocol development in collaboration with the project management team. Enjoy the flexibility of a home-based position with occasional onsite meetings and up to 10% travel to attend study team meetings and academic conferences. This role reports jointly to the Senior Project Manager, Clinical Operations leader, and the study PI. Elevate your career while making a significant impact in the realm of ALS research.
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, Norton Thoracic Institute, Cancer Center at St. Joseph's, Ivy Brain Tumor Center, and St. Joseph's Level I Trauma Center (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. Josephs is considered a sought-after destination hospital for treating the most complex cases from throughout the world. Every day, approximately 20 percent of the hospitals patients have traveled from outside of Arizona and the United States to seek treatment at St. Josephs.
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.
Look for us on Facebook and follow us on Twitter.
Responsibilities:The Clinical Research Regulatory Project Manager position exists to support research divisions engaged in Contract Research Organization (CRO) activities as well as the conduct of clinical trials at a site level. A unique skill-set with high attention to detail and subject matter expertise in Clinical Research Regulatory Affairs management is essential to drive effectiveness eliminate redundancies and increase both sponsor and site(s) performance. In addition to managing dual (local site and CRO) regulatory obligations this role is responsible for building and maintaining relationships across the CRO site network to ensure external sites are set up for success. Obligations include proactively addressing regulatory site needs to resolve issues contribute to development of CRO policies work instructions and/or regulatory sections within study specific Manuals of Operations (MOPs). In summary this position is accountable to ensure ongoing regulatory compliance throughout the conduct of clinical trials at both a local site level and across the CRO multi-site network. This responsibility includes drafting and submission of regulatory documents and performing quality reviews of regulatory documents to ensure document accuracy reviewed and approved by obligatory review board (IRB Scientific Review Committees FDA Privacy Boards etc.) The scope of this position begins at the time of study concept site initiation and until formal study close-out.
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
#LI-DH
Qualifications:Three years of related experience.
Education:
Bachelors degree in biosciences healthcare or healthcare management and/or equivalent combination of education and experience
Masters degree in biosciences, healthcare or healthcare management, business or public health preferred.
Licensure
Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), Certified IRB Professional (CIP), Certified IRB Manager (CIM) or Certified Clinical Research Associate (CCRA) preferred.
Special Skills
Proficient to advanced MS office skills; strong organizational skills; demonstrated knowledge of organizational and administrative support processes.
Excellent verbal and written communication and interpersonal skills.
High level of initiative and self-direction.
Training
Experience in one or more of the following areas: biosafety, animal care and use, institutional ethics review, research administration, audit, monitoring or other area of research compliance or oversight.
