Clinical Research Coordinator II

5 days ago

Newport Beach, United States Hoag Health System Full time
Salary Range: $35.5900 - $54.7500 /hour. Actual compensation may vary based on geographic location, work experience, skill level, and education.

Reporting to the Clinical Research Supervisor, Clinical Research Manager, or Director of Clinical Research Operations, the Clinical Research Coordinator II (CRC-II) is responsible for all aspects of clinical research activities and works in close cooperation with study physicians, inter- and intradepartmental stakeholders, and sponsors. The CRC-II provides study management, support, and coordination for FDA regulated research industry-sponsored, government funded, and/or investigator initiated clinical research trials. This may include blood collection, data and trials that have therapeutic or device component. The CRC-II ensures smooth, accurate process of clinical studies from the planning, implementation, and post-study closure procedures.

The CRC-II is involved in all aspects of the clinical research process included, but no limited to protocol review, preparation and administration of the informed consent, development of study treatment plans, completion of study related visit forms, ensuring protocol required assessments are completed per study guidelines, processing of lab samples per IATA standards, and regular communication with study sponsors and their collaborators.

Discusses research study with potential study subjects and answers any questions (may refer questions to Principal Investigator or Sub-Investigator when appropriate) while obtaining informed consent.

Responsible for development of study flow sheets, prepare study source documentation, gather study data, and assess subject for study eligibility (inclusion/exclusion). In addition, the CRC-II will record protocol specific assessments and treatments, ensure collection and shipment of samples, complete study forms to submit to sponsors and/or appropriate agencies, collect, enters and clean data into study database while maintaining data quality. I. He/she will host study team meetings, attend site initiation visits (SIVs) and perform other duties as assigned.

Must be knowledgeable of Good Clinical Practices, protection of human subjects in research practices, and FDA regulatory guidelines regarding clinical research.

Education And Experience

  • High School Diploma with 2-3 years of Clinical Research Coordinator experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.
  • 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, & 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

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 providing employees with a work environment free of discrimination and harassment. Hoag hires a diverse group of people in a manner that allows them to reach their full potential in the pursuit of organizational objectives.

  • Clinical Research Coordinator Specialist

    2 days ago

    Newport Beach, United States Wake Research Full time

    Job OverviewM3 Wake Research, a leading clinical research company, is seeking a highly skilled Clinical Research Coordinator to join our team in Newport Beach, CA. This role offers a competitive salary of $27-$37 per hour.About the Role:Manage and coordinate daily clinical trial activities under the guidance of the Principal Investigator.Assist with...

  • Clinical Research Professional

    2 days ago

    Newport Beach, United States Wake Research Full time

    Job OverviewM3 Wake Research, an M3USA Company, is a leading clinical research organization (CRO) with a strong presence in the US. With over 30 owned and managed research sites across the country, we are one of the largest independent CROs in the US.We are currently seeking a Clinical Research Coordinator to join our team at our Newport Beach, CA location.

  • Clinical Research Coordinator RN

    4 weeks ago

    Newport Beach, United States BAHAMA Consulting Full time

    TITLE: Clinical Research Coordinator RN LOCATION: Newport Beach, CA (Onsite) SCHEDULE: 8:30 AM – 5 PM PAY: $99K - $152K Annual DOEThis is the pay range that BAHAMA Consulting reasonably expects to pay someone for this position.SUMMARY: The Clinical Research Coordinator RN - Start-Up will support and participate in the overall startup activities for the...

  • Clinical Research Coordinator RN

    4 weeks ago

    Newport Beach, United States BAHAMA Consulting Full time

    TITLE: Clinical Research Coordinator RN LOCATION: Newport Beach, CA (Onsite) SCHEDULE: 8:30 AM – 5 PM PAY: $99K - $152K Annual DOEThis is the pay range that BAHAMA Consulting reasonably expects to pay someone for this position.SUMMARY: The Clinical Research Coordinator RN - Start-Up will support and participate in the overall startup activities for the...

  • Clinical Research Coordinator

    2 weeks ago

    Newport Beach, United States Piper Companies Full time

    Piper Companies is currently searching for an experienced Clinical Research Coordinator in Newport Beach, CA to workfor a well-renowned clinical research site services organization focused on Phase I-IV clinical trials. Responsibilities of the Clinical Research Coordinator: Coordinate daily clinical trial activities and conduct of the study Assist in...

  • Clinical Research Coordinator

    2 weeks ago

    Newport Beach, United States Piper Companies Full time

    Piper Companies is currently searching for an experienced Clinical Research Coordinator in Newport Beach, CA to workfor a well-renowned clinical research site services organization focused on Phase I-IV clinical trials. Responsibilities of the Clinical Research Coordinator: Coordinate daily clinical trial activities and conduct of the study Assist in...

  • Clinical Research Coordinator

    2 weeks ago

    Newport Beach, United States Piper Companies Full time

    Zachary Piper Solutions  is seeking a  Clinical Research Coordinator to join a site located in Newport Beach, California . The Clinical Research Coordinator will work On-Site 5 days a week. Responsibilities of the Clinical Research Coordinator include : ·Assisting PI in screening and review of study participants eligibility ·Maintaining case...

  • Clinical Research Coordinator

    1 week ago

    Newport Beach, United States Piper Companies Full time

    Zachary Piper Solutions  is seeking a  Clinical Research Coordinator to join a site located in Newport Beach, California . The Clinical Research Coordinator will work On-Site 5 days a week. This job opens for applications on 12/20/2024. Applications for this job will be accepted for at least 30 days from the posting date. Responsibilities of the...

  • Clinical Research Coordinator

    2 weeks ago

    Newport Beach, United States TotalMed, Inc. Full time

    Job Title: Clinical Research CoordinatorLocation: Newport Beach, CA 92660Schedule: Monday-Friday 8:00am-5:00pmPay: $32/hr + Benefits: Med/Den/Vis, 401k, PTOFull-Time Direct Hire!Job Description:The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the guidance of the clinical research site management and...

  • Clinical Research Nurse

    1 month ago

    Newport Beach, United States Integrated Resources, Inc ( IRI ) Full time

    The Clinical Research Coordinator RN Startup will support and participate in the overall startup activities for the Client Center for Clinical Research (HCCR) within Client Memorial Presbyterian Hospital. Provides support and coordination for FDA regulated research including drug/device/biologic studies that may involve industry sponsored Phase I, II, III...

  • Clinical Research Nurse

    1 month ago

    Newport Beach, United States Integrated Resources, Inc ( IRI ) Full time

    The Clinical Research Coordinator RN Startup will support and participate in the overall startup activities for the Client Center for Clinical Research (HCCR) within Client Memorial Presbyterian Hospital. Provides support and coordination for FDA regulated research including drug/device/biologic studies that may involve industry sponsored Phase I, II, III...

  • Clinical Research Startup Coordinator

    1 month ago

    Newport Beach, United States Russell Tobin Full time

    Russell Tobin is seeking a Clinical Research Startup Coordinator for a regional health care delivery network.Job Title: Clinical Research Startup CoordinatorLocation: Newport Beach, CA 92663 (On-Site)Job Type: Direct HireEst. Start Date: December 2024Hours: 8:30 am – 5pmPay Range: $37 - $47 per hourPrimary Duties and Responsibilities:The Clinical Research...

  • Clinical Research Startup Coordinator

    1 month ago

    Newport Beach, United States Russell Tobin Full time

    Russell Tobin is seeking a Clinical Research Startup Coordinator for a regional health care delivery network.Job Title: Clinical Research Startup CoordinatorLocation: Newport Beach, CA 92663 (On-Site)Job Type: Direct HireEst. Start Date: December 2024Hours: 8:30 am – 5pmPay Range: $37 - $47 per hourPrimary Duties and Responsibilities:The Clinical Research...

  • Clinical Research Associate II

    2 weeks ago

    Ponte Vedra Beach, Florida, United States Treace Full time

    Job TitleClinical Research Associate IIAbout the JobWe are seeking a highly skilled Clinical Research Associate II to join our team at Treace Medical Concepts, Inc. As a key member of our clinical research team, you will be responsible for overseeing clinical trial activities at investigational sites, conducting and writing accurate visit reports in...

  • Clinical Research Coordinator

    1 month ago

    Newport Beach, United States Medix Full time

    Job DescriptionJob DescriptionClinical Research CoordinatorGreat opportunity to work with a big name sponsor on an Ophthalmology study100% ON SITEPosition Summary:The candidate will be coordinating clinical research protocols from study start up to close out. This candidate will work closely with all research staff to collect, store and maintain data in...

  • Clinical Research Coordinator RN Specialist

    2 weeks ago

    Newport Beach, California, United States BAHAMA Consulting Full time

    Job SummaryThis is an exciting opportunity to join BAHAMA Consulting as a Clinical Research Coordinator RN Specialist. As a key member of our team, you will play a vital role in supporting and participating in the overall startup activities for the Center for Clinical Research within the hospital. Your primary responsibilities will include ensuring timelines...

  • RN Clinical Research Coordinator Lead

    2 weeks ago

    Newport Beach, California, United States BAHAMA Consulting Full time

    Job DescriptionBAHAMA Consulting is seeking a highly skilled RN Clinical Research Coordinator Lead to support and participate in the overall startup activities for the Center for Clinical Research within the hospital. As a key member of our team, you will play a vital role in ensuring timely activation of clinical studies, participating in study feasibility...

  • TotalMed, Inc. | Clinical Research Coordinator

    1 week ago

    newport beach, United States TotalMed, Inc. Full time

    Job Title: Clinical Research CoordinatorLocation: Newport Beach, CA 92660Schedule: Monday-Friday 8:00am-5:00pmPay: $32/hr + Benefits: Med/Den/Vis, 401k, PTOFull-Time Direct Hire!Job Description:The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the guidance of the clinical research site management and...

  • TotalMed, Inc. | Clinical Research Coordinator

    2 weeks ago

    newport beach, United States TotalMed, Inc. Full time

    Job Title: Clinical Research CoordinatorLocation: Newport Beach, CA 92660Schedule: Monday-Friday 8:00am-5:00pmPay: $32/hr + Benefits: Med/Den/Vis, 401k, PTOFull-Time Direct Hire!Job Description:The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the guidance of the clinical research site management and...

  • Senior Regulatory Coordinator

    2 months ago

    Newport Beach, United States Russell Tobin Full time

    Russell Tobin is seeking a Sr. Clinical Research Regulatory Coordinator for a regional health care delivery network.Job Title: Sr. Clinical Research Regulatory CoordinatorLocation: Newport Beach, CA 92663 (On-Site)Job Type: Direct HireEst. Start Date: January 6, 2025Hours: 8:30 am – 5pmPay Range: $37.38 - $57.46 per hourJob Summary:The Sr. Clinical...