Note: The job is a remote job and is open to candidates in USA. Kaiser Permanente is a healthcare organization seeking a Clinical Research Coordinator II to support clinical trials research. The role involves collecting data, preparing study documentation for regulatory submission, and assisting with compliance and quality control measures.
Responsibilities
- Pursues effective relationships with others by sharing resources, information, and knowledge with coworkers and members
- Completes work assignments by applying up-to-date knowledge in subject area to meet deadlines; follows procedures and policies, and applies data and resources to support projects or initiatives with limited guidance and/or sponsorship
- Assists in budgeting and financing by: developing a working understanding of how to provide input on implementing budget components for internally funded standard projects
- Conducts clinical research by: collecting data in clinical trials (e.g., recruiting human subjects, administering surveys and/experiments) following general directions; leveraging a working knowledge of source data and the tools leveraged for analyzing, and interpreting clinical data; developing a working knowledge of clinical trials, studies, and interventions at the site-level; contributing to the development of standard clinical research protocols and other processes of clinical trials with limited guidance; supporting the preparation of study documentation sent to regulatory bodies (e.g., IRB) for review and approval prior to implementation, under guidance; may also be responsible for supporting or executing standard clinical trial activities (e.g., informed consent process, lab support and processing, pharmaceutical documentation data, sample processing, adverse event assessment process); and may be involved in supporting standard research lab operations(e.g., biological specimen collection, including patient preparation, labeling, handling, preservation or fixation, processing or preparation, and transportation and storage of specimens), with guidance
- Supports research compliance by: learning to draft and submit clinical trial applications, under guidance, in compliance and consistency with all applicable federal, state, and local regulations and KP policies and procedures; assisting with the identification of compliance and/or quality issues, escalating as necessary; implementing updates to compliance-monitoring/audit systems and documentation with guidance; learning to and performing data entry tasks with minimal supervision to assist with risk-management; implementing research protocols, procedures, and guidance to ensure confidentiality, privacy, and security of clinical research data with minimal supervision; and leveraging basic research expertise to provide guidance to investigators and other key stakeholders to ensure compliance with IRB approved protocols and local and federal guidelines
- Learns to maintain internal and external effective working relationships by: leveraging a working knowledge of how to support important research stakeholders and projects within their unit; communicating, under minimal guidance, with key contractors and subcontractors, study sponsors, collaborating internal and/or external clinical sites, and data coordinating centers as applicable; and developing materials for supporting the education of staff and/or participants on standard protocols, documentation procedures, clinical best practices, or timeliness of submissions under guidance
- Ensures documentation of clinical research files by: completing documentation of all research activities (e.g., consent forms, reports, tracking forms) with general directions and limited guidance; assisting with the development of standard quality control and/or assurance measures and documenting feedback for the research staff and management; assessing volunteers and/or patients for eligibility to participate in Clinical Trials using standard procedures and criteria; and leveraging a working knowledge of how to monitor and audit Clinical Trials as well as documenting findings
Skills
- Bachelors degree in Science, Public Health, Health Care Administration, or a directly related field
- Minimum three (3) years of experience in clinical research or a directly related field
- Knowledge, Skills, and Abilities (KSAs): Ethical Conduct
- Data Quality
- Business Relationship Management
- Managing Diverse Relationships
- Stakeholder Management
- Computer Literacy
- Accountability
- Adaptability
- Autonomy
- Organizational Skills
- Compliance
- Laboratory Procedures
- Laboratory Equipment
- Innovative Mindset
- Certified Clinical Research Professional (CCRP) from Society of Clinical Research Associates (SoCRA)
- ACRP Certified Professional
- Certified Clinical Research Associate
- Certified Clinical Research Coordinator
- Certified Principal Investigator
- ACRP Medical Device Professional
- ACRP Project Manager from Association of Clinical Research Professionals (ACRP)
- Certified in Healthcare Compliance (CHC) from Healthcare Compliance Association (HCCA)
- Basic Life Support (BLS) Certification
Benefits
- Kaiser Permanente strives to offer a market competitive total rewards package and is committed to pay equity and transparency.
- Travel: Yes, 10 % of the Time
- Work Setting: Flexible
Company Overview