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Clinical Research Coordinator II

CIBD

Clinical Research Coordinator II

Orange, CA
Full Time
Paid
  • Responsibilities

    The Center for Inherited Blood Disorders (CIBD) is a mission-driven non-profit focused on delivering high-quality, comprehensive, and family-centered care to improve the quality of life for children and adults with blood disorders. When choosing a career with CIBD, you will be part of a growing organization dedicated to improving public health and committed to your professional development.

    Job Summary

    The Clinical Research Coordinator II (CRC II) is responsible for coordinating clinical studies in accordance with Institutional policy, Good Clinical Practice, and International Council for Harmonization (ICH) guidelines, as adopted by the Food and Drug Administration (FDA). The CRC II manages moderate complexity trials and assignments will be adjusted gradually to add increased responsibility based on demonstrated competency. The CRC II follows and maintains recordkeeping systems and procedures to ensure compliance with study protocols and all appropriate regulations. The CRC II will attend clinic as needed to perform activities including, but not limited to: assisting in recruitment activities, administering questionnaires, answering questions regarding future appointments, and randomizing patients to study. The CRC II also creates and maintains the research record for the compilation, registration and submission of data, as required by Sponsor.

    Essential Job Duties

    Ensures protocol adherence by understanding, communicating and making sure the study parameters are ordered and carried our per protocol requirements.

    Abstracts data from the medical record and completes paper and electronic case report forms, including responding to any requests for data clarification, and maintains all necessary documents.

    Manages the collection of significant information and data, ensures that it is precise and accurate, and monitoring it throughout duration of the study.

    Fulfills sponsor requirements, while optimizing the safety of research subjects, by monitoring and reporting important information, including: adverse events, unanticipated problems, and other information required by the sponsor protocol.

    Assembles lab kits and other supplies in preparation to obtain required bio-specimen samples and ships samples externally according to International Air Transport Association (IATA) requirements, to appropriate laboratories for processing.

    Requirements

    Bachelor's of Science degree in a related field or 4 years of equivalent experience/training

    Minimum of 1 year of clinical research experience as a CRC I

    Licensure/Certification

    Basic Life Support

    HIPAA

    Other Preferred Skills and Qualities

    Degree in a life science or related field from an accredited college or university.

    Clinical research certification (e.g., ACRP, SOCRA).

    IATA certification for the shipment of biological samples and for shipments using dry ice.

    CITI and Good Clinical Practices (GCP) certification.

    Knowledgeable and skilled in basic laboratory procedures for routine sample processing.

    Certified Phlebotomist.

    Spanish speaking

    Benefits

    100% employee coverage of medical and vision, and 99% employee coverage of dental

    Life insurance

    Paid Time Off

    10 observed paid holidays

    403b retirement plan with 4% match

    Compensation offered will be determined by factors such as location, level, job-related knowledge, skills, and experience.

    About the Organization

    The Center for Comprehensive Care & Diagnosis of Inherited Blood Disorders (CIBD), a 501(c)3 non-profit organization, is committed to providing comprehensive care for patients and their families with rare, chronic inherited blood disorders. CIBD is a part of a nationwide network of over 140 Hemophilia Treatment Centers that use multidisciplinary teams of blood disorder specialists to provide expert comprehensive diagnosis, medical care, outreach, education, outcomes monitoring, surveillance, and prevention services to people with hemophilia, Sickle-Cell Anemia, Thalassemia, Von Willebrand Disease, and other related hematology conditions. CIBD is the regional grantee for the Western States Region/Region IX providing regional leadership, fiscal and administrative oversight, grants management, capacity building, clinical education, technical assistance, evaluation, and outreach to public and private health agencies at the local, state, and federal levels.

    The Center for Inherited Blood Disorders is an Equal Opportunity/Affirmative Action Employer advancing inclusive excellence. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected categories covered by the company's non-discrimination policy.

    We are committed to attracting and retaining a diverse workforce along with honoring unique experiences, perspectives, and identities. Together, our community strives to create and maintain working and learning environments that are inclusive, equitable and welcoming.

    www.cibd-ca.org