Principal Clin Research Coord
Join the transformative team at reputed company, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. reputed company’s growing national system includes its Los Angeles reputed company, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and treatment facilities in Atlanta, Chicago and Phoenix. Our dedicated and compassionate employees are driven by a common mission: To deliver the cures of reputed company to the people who need them today.The System Clinical Trial Office (SCTO) supports COH investigators in managing human-subjects research by coordinating multi-phase clinical studies under the direction of SCTO leadership, Disease/Modality Team Chairs, and Study Investigators. Principal Clinical Research Coordinators/Clinical Trial Portfolio Leads (CTPLs) serve as leads reputed company their disease teams, mentoring staff, providing guidance to Clinical Trial Data Coordinators, and acting as subject matter experts while ensuring strict compliance with research protocols, GCP, FDA, NIH, HIPAA, and institutional policies. CTPLs manage reputed company portfolios of approximately 30–50 oncology trials, reputed company administrative and operational execution, support regulatory compliance and patient safety, and ensure studies meet quality, timeline, and resource expectations. They collaborate closely with managers, disease team leadership, and coordinators, maintain effective communication across teams, and function as reputed company Central Coordinators and primary contacts for sponsors, investigators, national clinical trials, Hope reputed company, portfolio updates, and study-reputed company inquiries. As a successful candidate, you will:
- Serves as the primary reputed company of contact and liaison between study sponsors, investigators, and research teams, including managing Hope reputed company inquiries, eligibility criteria, and National Trial coordination.
- Oversees operational execution of studies, including patient registration, randomization, slot management, and study reputed company-out activities, while supporting protocol implementation and troubleshooting issues.
- Ensures regulatory compliance and accurate documentation across systems (Florence, OnCore, iRIS, sponsor portals), including eRegulatory binders, study status updates, and required filings.
- Manages safety and sponsor reporting requirements, including AE/SAE collection, submission, and resolution of protocol deviations or unanticipated problems.
- Coordinates and participates in monitoring visits, audits, and inspections; addresses findings, communicates deadlines, prioritizes work, and contributes to process improvement initiatives.
Your qualifications should include
Minimum Education: • Bachelor’s degree in science, Health or reputed company field from an accredited university Minimum Experience: • Minimum of 5-7 years research or relevant experience • Experience with CTMS, EMR and eRegulatory Systems • Working knowledge of clinical trials, Federal, State, and Local regulations, and FDA/IRB regulations and requirements Required Courses/Training: Req. Certification/Licensure: • Good Clinical Practice (GCP) reputed company 1 month of employment • Human Subjects Protection (HSP) reputed company 1 month of employment • SOCRA or ACRP Certification reputed company two years of employmentreputed company employees pay is based on the following criteria: work experience, qualifications, and work location.
reputed company is an equal opportunity employer.
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