Clinical Research Coordinator II Position

2 days ago


Newport Beach, United States Hoag Full time

Job Summary:


The Clinical Research Coordinator II will provide study management, support, and coordination for FDA regulated research industry-sponsored, government funded, and/or investigator initiated clinical research trials.


Key Responsibilities:



  • Provide study management, support, and coordination for FDA regulated research industry-sponsored, government funded, and/or investigator initiated clinical research trials.
  • Ensure smooth, accurate process of clinical studies from the planning, implementation, and post-study closure procedures.
  • Involved in all aspects of the clinical research process, including protocol review, preparation and administration of informed consent, development of study treatment plans, completion of study related visit forms, and ensuring protocol required assessments are completed per study guidelines.
  • Discuss research study with potential study subjects and answer any questions while obtaining informed consent.
  • Responsible for development of study flow sheets, preparation of study source documentation, gathering study data, and assessing subject for study eligibility (inclusion/exclusion).
  • Record protocol specific assessments and treatments, ensure collection and shipment of samples, complete study forms to submit to sponsors and/or appropriate agencies, collect, enter and clean data into study database while maintaining data quality.
  • Host study team meetings, attend site initiation visits (SIVs), and perform other duties as assigned.

Requirements:



  • High School Diploma with 2-3 years of Clinical Research Coordinator experience and demonstrated skills to successfully perform the assigned duties and responsibilities.
  • Excellent verbal and written communications and presentation skills, excellent organizational skills, and excellent interpersonal skills to work effectively in a diverse team.
  • Attention to details.
  • Proficiency with Microsoft Word, PowerPoint, and Windows.
  • Excellent analytical and problem-solving skills.
  • Ability to work effectively in a fast-paced, team-based environment, project management and coordination skills, ability to prioritize tasks and meet multiple deadlines on concurrent projects.
  • Ability to establish cooperative working relationships with patients, co-workers, and physicians.

PREFERRED QUALIFICATIONS:



  • Medical terminology required. Working knowledge of FDA, NIH and OHRP regulatory requirements and ICH GCP guidelines.
  • Understanding of clinical trial methodologies and experience filing Institutional Review Board documents.
  • Ability to abstract data from medical records and transfer it to data collection forms or directly into databases.
  • International Air Transport Association (IATA) Certification.
  • Current ACRP or SoCRA Certification.

Certifications Preferred:



  • May only perform blood draws by meeting and maintaining State of California Certified Phlebotomy Technician I (CPTI) Certification.

Working at Hoag:


We are a leading healthcare organization committed to providing exceptional patient care and advancing the science of medicine through innovative research and education.


Why Hoag:


At Hoag, you will find a work environment that values collaboration, innovation, and compassion. As a Clinical Research Coordinator II, you will be part of a dynamic team that is dedicated to improving patient outcomes and advancing medical research.


What We Offer:


Hoag offers a competitive salary and benefits package, as well as opportunities for professional growth and development.


How to Apply:


Please submit your application through our website.



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