- Understand clinical trial protocols (rationale, inclusion/exclusion criteria, study design, study medication and comparators, mechanism of action, required procedures, etc).
- Review detailed medical records including electronic medical records, lab reports, biopsies, radiology scans and other related medical data to confirm if a patient is eligible for a clinical trial.
- Liaise with other clinical research staff, medical providers and clinic staff to coordinate screening activities including but not limited to confirming patient eligibility, scheduling consents, placing screening orders to support patient randomization.
- Communicate individual patient and study level details with clinical trials sponsors, contract research organizations and other external providers.
- Document patient and study level activities in clinical trial management systems, tracking documentation and electronic medical records.
- Support management of regulatory documentation, investigational product storage and accountability as well as clinical data entry and query resolution
- Perform clinical trial visits with patients in partnership with clinic staff and providers in accordance with clinical trial protocols.
- Performs additional tasks as assigned by clinical research or clinic leadership.
- Responsible for overall conduct of assigned clinical research responsibilities.
- Bachelor's degree in life sciences or equivalent combination of other degrees or certifications (nursing, phlebotomy, medical assistant, etc) and experience
- 4+ years of clinical research experience
- In-depth knowledge of clinical research and ICH-GCP guidelines
- Proficient in Microsoft Office, Outlook, and other computer use
- Ability to organize a high-volume workload and prioritize tasks accordingly
- Strong work ethic, personal integrity, focus on collaboration, timeliness and dependability
- Bilingual in English and Spanish preferred, not required
- 8 Hour Day Shift, Monday to Friday
- Local travel between corporate headquarters and treatment clinics
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Senior Clinical Research Coordinator - Cerritos, United States - The Oncology Institute
Description
Founded in 2007, The Oncology Institute of Hope and Innovation (TOI) is advancing oncology by delivering highly specialized, value-based cancer care in the community setting.
TOI is dedicated to offering cutting edge, evidence-based cancer care to a population of more than 1.7 million patients including clinical trials, stem cell transplants, transfusions, and other care delivery models traditionally associated with the most advanced care delivery organizations.
With 100+ employed clinicians and more than 800 teammates in 60+ clinic locations and growing. TOI is changing oncology for the better.This is a fantastic opportunity to join our TOI Clinical Research team
Description
The Senior Clinical Research Coordinator conducts clinical research visits in accordance with ICH-GCP, TOI Clinical Research SOPs and sponsor protocols.
Education and Experience:
Skills:
Schedule and Location:
Factors that may be used to determine your actual salary may include your specific skills, how many years of experience you have and comparison to other employees already in this role.
Pay Transparency for hourly teammates$30-$35 USD