Clinical Research Regulatory Project Manager
About Us
Inspired by faith. Driven by innovation. Powered by humankindness. CommonSpirit Health is building a healthier future for all through its integrated health services. As one of the nation’s largest nonprofit Catholic healthcare organizations, CommonSpirit Health delivers more than 20 million patient encounters annually through more than 2,300 clinics, care sites and 138 hospital-based locations, in addition to its home-based services and virtual care offerings.
Our Mission
As CommonSpirit Health, we make the healing presence of God known in our world by improving the health of the people we serve, especially those who are vulnerable, while we advance social justice for all. To learn more about a calling that defines and unites, please click here for more information about our mission, vision, and values.
The posted compensation range of $32.38 - $48.17 /hour is a reasonable estimate that extends from the lowest to the highest pay CommonSpirit in good faith believes it might pay for this particular job, based on the circumstances at the time of posting. CommonSpirit may ultimately pay more or less than the posted range as permitted by law.
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.
Responsibilities Include:
- Acts as the primary regulatory liaison between the Dignity Health CRO and external sites involved in the conduct of the clinical trials. Utilizes problem-solving skills to promote positive working relationships with the site and staff.
- Assists external sites with IRB submissions, maintenance of regulatory documents, and responding to study related regulatory questions from sites, vendors, and sponsors in a timely fashion
- Ensures new protocols are submitted to the Institutional Review Board (IRB) within established time frames by drafting and coordinating appropriate paperwork. Completes all necessary regulatory submissions in a timely manner.
- Develops and maintains Trial Master Files (TMF) as well as study specific regulatory binders for use by the site(s).
- Maintains investigator CVs and medical licenses, staff CVs and licenses, training certificates and lab licenses/certifications, ensuring all documents are current.
- Develops applicable policies, procedures, checklists, reports and other templates for use by the sites. Ensures compliance with all applicable regulatory requirements.
- Maintains in-depth knowledge of frequently changing federal regulations and guidelines, and other literature related to research involving the use of animals and/or the inclusion of human subjects, including human subject protection.
- Monitors completeness and quality of regulatory documentation and performs site document verification If applicable, oversees IND/IDE and local and central IRB applications and communication with regulatory agencies (FDA, Health Canada, etc.) for studies with investigator held IND/IDE project.
- Assists in the development of patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines.
- Prepares for and assists with internal and external audits/inspections and monitoring visits.
- Assists with special projects that arise as assigned.
Job Requirements
Education and Experience:
Three years of related experience required
Bachelors Other in biosciences, healthcare or healthcare management and equivalent combination of education and experience
Masters Other in biosciences, healthcare or healthcare management, business or public health preferred
Five+ years of related experience preferred
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.
Preferred Certifications:
Clinical Research Associate (CCRA)
Certified Clinical Research Coordinator ACRP (CCRC-ACRP)
Certified Clinical Rearch Coordinator SCRA (CCRC-SCRA)
Where You'll Work
Hello humankindness Located conveniently in the heart of Phoenix, Arizona,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, 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. 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. Look for us on Facebookand follow us on Twitter. For the health of our community ... we are proud to be a tobacco-free campus.
Depending on the position offered, CommonSpirit Health offers a generous benefit package, including but not limited to medical, prescription drug, dental, vision plans, life insurance, paid time off (full-time benefit eligible team members may receive a minimum of 14 paid time off days, including holidays annually), tuition reimbursement, retirement plan benefit(s) including, but not limited to, 401(k), 403(b), and other defined benefits offerings, as may be amended from time to time. For more information, please visit https://www.commonspirit.careers/benefits.
Unless directed by a Collective Bargaining Agreement, applications for this position will be considered on a rolling basis. CommonSpirit Health cannot anticipate the date by which a successful candidate may be identified.
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Equal Opportunity
CommonSpirit 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 click here.
CommonSpirit Health™ will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their 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). CommonSpirit Health™ participates in E-Verify.