Overview
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 Facebook and follow us on Twitter.
For the health of our community ... we are proud to be a tobacco-free campus.
Responsibilities
This Clinical Research Associate will report directly to the BNI Clinical Research Organization (CRO) Program Manager. The CRA position will independently be responsible for clinical monitoring activities and overall project administration to oversee the progress of multi-center, investigator initiated, or industry sponsored clinical studies throughout the United States and Canada. The CRA will travel to assigned clinical research sties to conduct approx. 25-30 clinical trial monitoring visits each year, and will also complete remote/centralized monitoring visits to ensure clinical studies are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), International Conference on Harmonization- Good Clinical Practice (ICH-GCP) guidelines, and all applicable regulatory requirements.
The CRA will be responsible for the timely reporting of all monitoring visit findings, and is expected to complete comprehensive monitoring reports and associated deliverables to provide back to the Sponsor and the clinical sites. Additionally, the CRA role will oversee clinical site training activities and, conduct remote webinar and onsite protocol training for Physician Site Investigators, Clinical Research Coordinators, Research Nurses, and other delegated healthcare study personnel. The CRA will be responsible for managing all monitoring visit travel arrangements and travel expense reporting activities in accordance with Dignity Health’s travel and expense purchasing policy. The CRA role will actively participate in departmental quality control and program development activities as directed by the BNI CRO Program Manager.
Responsibilities Include:
- Responsible for all aspects of clinical monitoring, site management, and trial administration as prescribed in the monitoring plan and as instructed by program leadership. Employee is responsible for working with sites during study start up, including assessing site feasibility as required, provide ongoing training and site initiation visits, conducting remote monitoring, and approx. 25-30 interim onsite and closeout field monitoring visits located throughout the US and Canada. During each monitoring visit the CRA is responsible for the evaluation of clinical data documentation, regulatory document review, monitor safety and conduct of study to ensure investigator and site compliance with study protocol, overall clinical objectives, FDA regulations, ICH/GCP guidelines, institutional/ CRO SOPs, and HIPAA guidelines. The CRA is expected to work cooperatively with study team and operations management to proactively drive project success.
- Completes preparation and submission of accurate and timely monitoring reports, and other requested deliverables, as outlined in the Study Monitoring Plan or as requested by program leadership.
- Effective long-term planning/scheduling of remote and on-site monitoring visits in accordance with the Study Monitoring Plan or as requested by program leadership.
- Perform Lead Study Monitoring activities as assigned, including acting as the primary liaison between BNI CRO and the Clinical Study Sponsor to ensure BNI CRO provides quality monitoring and site management customer services. The Lead Study Monitor will be responsible for the timely review of all monitoring deliverables, conduct co-monitoring visits and mentorship of CRA team members.
Qualifications
Minimum Required 2-3 years of clinical research experience required or a combination of equivalent experience and education.
Excellent written /oral communication, interpersonal, and organizational skills required.
Good presentation skills and ability to effectively communicate information and processes to a variety of audiences.
Ability to travel frequently on domestic and extended trips throughout the United States and Canada (up to 70% of the time), to perform clinical monitoring visits.
Proven attention to detail, excellent problem solving and customer service skills, and ability to multi-task. Education Bachelors Degree or equivalent combination of education and experience or its international equivalent in clinical, science, or health related field from an accredited institution required or a healthcare professional licensure such as a Registered Nurse or Physical Therapist. Special Skills Strong interpersonal skills to effectively navigate a matrix organizational structure and effectively lead cross functional teams.
Excellent communication skills (verbal and written) to effectively communicate complex information and processes to a variety of audiences.
Proven attention to detail, with strong analytical, critical thinking, problem solving, time management, and customer service skills.
Experience with Microsoft Office Suite Systems
Preferred:Electronic Data Capture System (EDC) skills preferredCCRA or CCRP certification preferred