Hoag Health System
Clinical Research Coordinator II : DIGESTIVE DISORDERS
Hoag Health System, Newport Beach, California, us, 92659
Clinical Research Coordinator II : DIGESTIVE DISORDERS
Primary Duties and Responsibilities
Manage all aspects of clinical research activities, collaborating with study physicians, stakeholders, and sponsors.
Provide study management, support, and coordination for FDA‑regulated industry‑sponsored, government‑funded, and investigator‑initiated trials.
Ensure the smooth, accurate progression of studies from planning through implementation to post‑study closure.
Conduct protocol review, prepare and administer informed consent, develop treatment plans, and complete visit forms.
Perform laboratory sample processing according to IATA standards and maintain regular communication with sponsors.
Accurately complete case report forms (CRFs), report adverse events and serious adverse events (SAEs), and schedule subject follow‑up visits.
Discuss study details with potential subjects, answer questions, and refer complex inquiries to the Principal Investigator.
Develop study flow sheets, prepare source documentation, gather data, and assess subject eligibility based on inclusion/exclusion criteria.
Record protocol‑specific assessments and treatments, manage sample collection and shipment, and submit study forms to sponsors and agencies.
Enter and clean data in the study database while maintaining data quality, and host study team meetings.
Attend site initiation visits (SIVs) and perform additional duties as assigned.
Demonstrate knowledge of Good Clinical Practice, human subject protection, and FDA regulatory guidelines.
Qualifications
High School Diploma with 2–3 years of Clinical Research Coordinator experience or equivalent education/training.
Excellent verbal and written communication, presentation, and organizational skills.
Attention to detail, analytical thinking, and problem‑solving ability.
Proficiency with Microsoft Word, PowerPoint, and Windows.
Project management and coordination skills with the ability to prioritize tasks and meet multiple deadlines.
Ability to establish cooperative relationships with patients, co‑workers, and physicians.
PREFERRED QUALIFICATIONS
Medical terminology knowledge; familiarity with FDA, NIH, and OHRP regulatory requirements and ICH GCP guidelines.
Understanding of clinical trial methodologies and experience filing Institutional Review Board documents.
Data abstraction from medical records into collection forms or databases.
IATA Certification.
ACRP or SoCRA Certification.
License Required N/A
License Preferred / Certifications May perform blood draws only if State of California Certified Phlebotomy Technician I (CPTI) certification is maintained.
About Us Hoag Memorial Hospital Presbyterian is a nonprofit regional health‑care delivery network in Orange County, California. It includes three acute‑care hospitals, sixteen urgent care centers, eleven health centers, a network of more than 1,800 physicians, 100 allied health members, 8,000 employees, and 2,000 volunteers. Hoag delivers personalized care and is recognized for its quality, service, and community impact.
Equal Opportunity Employer Hoag is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Hoag is committed to the principle of equal employment opportunity for all employees and to providing a workplace free of discrimination and harassment. Hoag hires a diverse group of people in a manner that allows them to reach their full potential.
Seniority Level
Entry level
Employment Type
Full‑time
Job Function
Research, Analyst, and Information Technology
Industry
Hospitals and Health Care
#J-18808-Ljbffr
Manage all aspects of clinical research activities, collaborating with study physicians, stakeholders, and sponsors.
Provide study management, support, and coordination for FDA‑regulated industry‑sponsored, government‑funded, and investigator‑initiated trials.
Ensure the smooth, accurate progression of studies from planning through implementation to post‑study closure.
Conduct protocol review, prepare and administer informed consent, develop treatment plans, and complete visit forms.
Perform laboratory sample processing according to IATA standards and maintain regular communication with sponsors.
Accurately complete case report forms (CRFs), report adverse events and serious adverse events (SAEs), and schedule subject follow‑up visits.
Discuss study details with potential subjects, answer questions, and refer complex inquiries to the Principal Investigator.
Develop study flow sheets, prepare source documentation, gather data, and assess subject eligibility based on inclusion/exclusion criteria.
Record protocol‑specific assessments and treatments, manage sample collection and shipment, and submit study forms to sponsors and agencies.
Enter and clean data in the study database while maintaining data quality, and host study team meetings.
Attend site initiation visits (SIVs) and perform additional duties as assigned.
Demonstrate knowledge of Good Clinical Practice, human subject protection, and FDA regulatory guidelines.
Qualifications
High School Diploma with 2–3 years of Clinical Research Coordinator experience or equivalent education/training.
Excellent verbal and written communication, presentation, and organizational skills.
Attention to detail, analytical thinking, and problem‑solving ability.
Proficiency with Microsoft Word, PowerPoint, and Windows.
Project management and coordination skills with the ability to prioritize tasks and meet multiple deadlines.
Ability to establish cooperative relationships with patients, co‑workers, and physicians.
PREFERRED QUALIFICATIONS
Medical terminology knowledge; familiarity with FDA, NIH, and OHRP regulatory requirements and ICH GCP guidelines.
Understanding of clinical trial methodologies and experience filing Institutional Review Board documents.
Data abstraction from medical records into collection forms or databases.
IATA Certification.
ACRP or SoCRA Certification.
License Required N/A
License Preferred / Certifications May perform blood draws only if State of California Certified Phlebotomy Technician I (CPTI) certification is maintained.
About Us Hoag Memorial Hospital Presbyterian is a nonprofit regional health‑care delivery network in Orange County, California. It includes three acute‑care hospitals, sixteen urgent care centers, eleven health centers, a network of more than 1,800 physicians, 100 allied health members, 8,000 employees, and 2,000 volunteers. Hoag delivers personalized care and is recognized for its quality, service, and community impact.
Equal Opportunity Employer Hoag is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Hoag is committed to the principle of equal employment opportunity for all employees and to providing a workplace free of discrimination and harassment. Hoag hires a diverse group of people in a manner that allows them to reach their full potential.
Seniority Level
Entry level
Employment Type
Full‑time
Job Function
Research, Analyst, and Information Technology
Industry
Hospitals and Health Care
#J-18808-Ljbffr