Clinical Research Associate

CommonSpirit Health

Phoenix (AZ)

On-site

USD 70,000 - 100,000

Full time

2 days ago

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Job summary

CommonSpirit Health's Saint Joseph's Hospital and Medical Center in Phoenix is seeking a Clinical Research Professional/CRA to advance ALS studies through rigorous monitoring, data integrity, and regulatory compliance across sites in the US and Canada.

You will manage trial activities, site initiation, training, and reporting, collaborating with Barrow Neurological Institute and other sites to ensure patient safety and scientific quality.

Qualifications

Bachelor's degree or its international equivalent in clinical, science, or health related field, or five years equivalent work experience in lieu of the degree.
Two (2)+ years of clinical research experience
Experience with Microsoft Office Suite Systems

Responsibilities

Monitor and manage all aspects of site monitoring and trial administration per the monitoring plan.
Coordinate study startup activities, site feasibility, training, initiation visits, remote monitoring, and 25–30 interim onsite visits across the US and Canada.
Submit accurate monitoring reports and deliverables in a timely manner as required by the plan and leadership.

Skills

Clinical research experience

Regulatory guidelines

Organizational skills

Attention to detail

Communication skills

Education

Bachelor's degree in clinical/science/health

Tools

Microsoft Office

Job description

Job Summary and Responsibilities

As our Clinical Research Professional you will be instrumental in advancing medical knowledge by expertly managing and executing clinical trials. You will ensure the highest standards of data integrity patient safety and regulatory compliance throughout the research process.

Every day you will manage trial activities including participant recruitment data collection and documentation serving as a key liaison for all stakeholders. You will ensure strict adherence to protocols and regulatory requirements from study initiation to completion.

To be successful in this role you will bring relevant clinical research experience and a strong understanding of regulatory guidelines. Your exceptional organizational skills attention to detail and ability to communicate effectively will be crucial in this dynamic field.

At Barrow Neurological Institute (BNI) one of the worlds premier neuroscience centers we are leading groundbreaking multicenter clinical research to accelerate discoveries for people living with amyotrophic lateral sclerosis (ALS). As part of our Academic Clinical Research Organization (CRO) you will join a nationally recognized team coordinating NIH/NINDS funded studies that are changing how ALS is diagnosed monitored and ultimately treated. We are seeking a motivated Clinical Research Associate (CRA) to support field monitoring activities across a network of leading academic medical centers participating in innovative ALS clinical research studies. This role offers the opportunity to work alongside dedicated research sites while ensuring the highest standards of participant safety regulatory compliance and data quality.

Position 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.

Participates in the quality control process for assigned monitoring activities and makes contributions to improve and adapt quality control procedures including the development of internal corrective and preventative action plans if needed and align service goals with internal and external client expectations Proactively participate in program development. This includes making contributions to the overall quality improvement of clinical monitoring services as well as actively collaborating with program leadership to expand and grow the CRO's professional portfolio.

Job Requirements

Required

Bachelors degree or its international equivalent in clinical, science, or health related field from an accredited institution or five (5) years equivalent work experience in lieu of the degree

Two (2)+ years of clinical research experience

Experience with Microsoft Office Suite Systems

Preferred

Registered Nurse: AZ

Physical Therapist: AZ

Occupational Therapist: AZ and

Clinical Research Associate

Certified Clinical Research Professional

Where You'll Work

Hello Humankindness: Join a Legacy of Healing at Saint Joseph's Hospital and Medical Center (SJHMC)

Ready to make a real difference? Join SJHMC in Phoenix AZ., a 571-bed nonprofit founded by the Sisters of Mercy over 125 years ago. We're more than a hospital; we're a global destination for life-changing care, embracing patients with humankindness.

Here, your calling will flourish. We're not just a workplace; we're a community dedicated to a mission of service.

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