What are the responsibilities and job description for the Clinical Research Coordinator II position at CIBD?
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
- AA or equivalent additional experience (BS preferred)
- Minimum of 3 years clinical research experience
- Prior experience coordinating investigational drugs studies
Licensure/Certification
- Basic Life Support
- HIPAA
Required Skills
- Intermediate/Advanced knowledge of medical terminology.
- Must be proficient in computer skills including Electronic Medical Record databases, MS office products, the Internet, facsimile machines, copiers, scanners and database software.
- Ability to interact effectively with professional, administrative staff, sponsor and regulatory representatives, patients, potential subjects, and referral sources.
- Highly skilled at chart review and abstracting data from patient charts.
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
- 50% dependent coverage of medical and vision
- FSA Health
- 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 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
Salary : $33 - $39
