Clinical Research Coordinator

Position Summary This position is responsible for coordinating various research projects from pre-study implementation through study closure. The role involves working independently in specimen acquisition, data extraction and entry, maintaining complete and accurate subject data and regulatory documentation, and analyzing data per protocol. Additionally, this position provides administrative and regulatory support, including recruiting, interviewing, scheduling study participants, and processing IRB and other regulatory documents, in accordance with federal, state, regulatory agency, and institutional requirements. Position Duties Ensure studies are conducted in compliance with FDA, OHRP, GCP, and institutional guidelines, including: 1. Reviewing regulatory requirements to ensure proper methods, practices, and procedures for all research activities. 2. Completing and submitting documents to IRB and institutional committees regularly. 3. Maintaining compliance with current and accurate documentation in regulatory binders. 4. Explaining study purpose, parameters, and requirements to participants alongside the principal investigator. Complete tasks required by study sponsors, including: 1. Providing regulatory documents to sponsors promptly. 2. Completing case report forms, data entry, and maintaining source documentation. 3. Tracking and reporting adverse events as per guidelines. 4. Coordinating research monitor visits and responding to data queries. Coordinate the process for opening new studies, including: 1. Obtaining background material on proposed research and presenting findings to the principal investigator. 2. Completing feasibility questionnaires. 3. Circulating confidentiality disclosures and trial agreements. 4. Creating study budgets and assessing financial feasibility. 5. Assisting in developing workflow procedures based on protocol. Participate in recruitment and selection of study participants, ensuring all inclusion and exclusion criteria are met during consent and entry processes. Coordinate and schedule medical procedures and tests required by the protocol. Provide study-specific education to participants and families in collaboration with the research team. Review financial reports, manage supplies and equipment inventory, and ensure operational efficiency. Engage in professional development to stay current with methodologies and practices. Perform miscellaneous duties as assigned.

Phoenix Children's Mission, Vision, & Values Mission:

To advance hope, healing, and the best healthcare for children and their families. Vision:

Phoenix Children’s will be the leading pediatric health system in the Southwest, recognized nationally for exceptional care, innovative research, and advanced medical education. Our Approach: Offering comprehensive care across ages, communities, and specialties. Investing in innovative research and emerging treatments. Advancing education and training for future clinical leaders. Advocating for children’s and families’ health and well-being. Values: Placing children and families at the center of all we do. Delivering exceptional care consistently. Collaborating with colleagues, partners, and communities. Setting and innovating pediatric healthcare standards. Ensuring care is accessible and affordable, with accountability.

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