Clinical Trials Coordinator
2 weeks ago
Role: Clinical Research Coordinator
Department: RSRCH-GRNT | Genetics Research Studies
Location: Phoenix
This role entails the management of diverse research initiatives from the initial planning stages through to project completion. The Clinical Research Coordinator will independently handle the collection of specimens, patient data extraction and entry, and ensure the maintenance of comprehensive and precise subject data alongside regulatory documentation. Additionally, this position provides essential administrative and regulatory support, including recruiting, interviewing, and scheduling study participants, while adhering to all applicable federal, state, and institutional regulations.
Key Responsibilities- Study Compliance: Ensure that all assigned studies are executed in alignment with the Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), Good Clinical Practices (GCP), and institutional protocols. Responsibilities include:
- Reviewing regulatory requirements to implement suitable methods and procedures for research activities.
- Completing and submitting necessary documents to the relevant Institutional Review Board (IRB) and committees.
- Maintaining accurate documentation in regulatory binders as mandated by regulations and sponsors.
- Collaborating with the principal investigator to communicate study objectives and requirements to participants.
- Sponsor Coordination: Fulfill all obligations set forth by study sponsors, including:
- Providing regulatory documents promptly.
- Completing case report forms and maintaining source documentation for all participants.
- Tracking and reporting adverse events in accordance with sponsor and institutional guidelines.
- Coordinating research monitor visits and addressing data inquiries.
- New Study Initiation: Facilitate the process of launching new studies by:
- Gathering necessary background information on proposed research projects and presenting findings to the principal investigator.
- Completing feasibility assessments.
- Circulating confidentiality agreements and trial contracts to relevant parties.
- Developing study budgets and collaborating with management to assess financial viability and required resources.
- Assisting in the creation of workflow procedures tailored to specific protocols.
- Participant Recruitment: Engage in the recruitment and selection of study participants, ensuring informed consent is obtained and that all eligibility criteria are satisfied.
- Medical Coordination: Schedule and coordinate various medical procedures and tests, including laboratory tests, imaging studies, and psychological evaluations as dictated by study protocols.
- Participant Education: Collaborate with the principal investigator and other team members to provide study-specific education to participants and their families, covering procedures, documentation, and treatment administration.
- Financial Oversight: Review financial reports related to study participant billing and expenditures, manage inventory levels of supplies, and initiate requisitions for replacements as necessary.
- Professional Development: Participate in ongoing professional development to stay current with methodologies and practices relevant to the patient population and research area.
- Additional Duties: Perform other job-related tasks as assigned.
Mission: To advance hope, healing, and the best healthcare for children and their families.
Vision: Phoenix Children's aims to be the leading pediatric health system in the Southwest, recognized nationally for exceptional care, innovative research, and advanced medical education.
Values:
- We prioritize children and families in all our endeavors.
- We deliver exceptional care consistently.
- We collaborate with colleagues and communities to enhance our impact.
- We set the standards for pediatric healthcare and innovate for the future.
- We are committed to making high-quality care accessible and affordable.
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Phoenix, Arizona, United States Phoenix Children's Hospital Full timeJob Overview Position Title: Clinical Research Coordinator Department: RSRCH-GRNT | Genetics Research Studies Location: Phoenix Position Summary This role is pivotal in overseeing a diverse range of research initiatives from the initial stages of study setup to the finalization of research activities. The Clinical Research Coordinator will operate...
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