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Clinical Research Operations Manager
2 months ago
Company Overview:
Shriners Children's is a community that honors, supports, and cherishes one another. We are dedicated to delivering exceptional patient care while embracing interdisciplinary education and research that has a global influence. We cultivate a learning atmosphere that values evidence-based practices, experience, innovation, and critical thinking.
Our values of compassion, integrity, accountability, and resilience define us as leaders in pediatric specialty care for children and their families.
Job Overview:
Shriners Children's stands as the leading medical center for pediatric burn, orthopedic, spinal cord injury, cleft lip and palate, and various pediatric subspecialties.
This role is full-time, exempt, and eligible for benefits. The compensation for this position is competitive and based on experience and departmental equity.
Responsibilities:
The Clinical Research Operations Manager (CROM) is a specialized, autonomous research professional responsible for the operational oversight of all clinical research activities at the site.
Reporting to the Hospital Administrator and the Research Programs Office, the CROM provides guidance and leadership in alignment with organizational policies, regulations, and applicable guidelines.
The CROM collaborates closely with the Chief of Staff, scientific and medical personnel, and other research staff to ethically recruit and consent vulnerable pediatric participants while ensuring the proper collection and protection of data.
In essence, the CROM serves as the primary liaison among research participants, local study teams, investigators, and sponsors.
The key responsibilities include ensuring proper study execution, participant safety, and the integrity of data management.
This position will oversee the daily operations of the clinical research program, ensuring standardized practices among staff and fostering interdisciplinary communication and collaboration.
Accountable for the site's research initiativesCollaborate effectively with leadership to uphold the research mission
Coordinate with the Department of Research Programs regarding clinical activities
Provide expertise, consultation, and mentorship to site personnel
Direct education and training for clinical research staff
Coordinate resources and services to successfully implement and monitor clinical research progress
Support the execution of approved research protocols
Responsible for tracking all project aspects, including Institutional Review Board (IRB) information, participant recruitment, and financial oversight
Facilitate the collection, statistical analysis, and dissemination of data results throughout clinical studies
This list is not exhaustive; the incumbent may be required to perform additional related duties and participate in special projects as assigned.
Qualifications:
Education
A Bachelor's or Master's degree in Clinical Research, a scientific discipline, or a healthcare-related field is preferred. In the absence of a degree, a minimum of 5 years of relevant experience in clinical research administration is required.
Certification/Licensure
Certification as a Clinical Research Coordinator is preferred.
Experience
A minimum of three years of clinical research experience, including site management, study management, and familiarity with IRB and federal regulations related to clinical research compliance, is required.
Experience coordinating intergroup or multi-site clinical studies is preferred.
Other
Current full vaccination status is required.