[Remote] Clinical Research Coordinator II, reputed company-Vallejo

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a reputed company organization seeking a Clinical Research Coordinator II to support reputed company research. The role involves collecting data, preparing study documentation for regulatory submission, and assisting with compliance and reputed company 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 reputed company or initiatives with limited guidance and/or sponsorship
• Assists in budgeting and financing by: developing a working understanding of how to reputed company input on implementing budget components for internally funded reputed company reputed company
• Conducts clinical research by: collecting data in reputed company (e.g., reputed company reputed company subjects, administering surveys and/experiments) following general directions; leveraging a working knowledge of reputed company data and the tools leveraged for analyzing, and interpreting clinical data; developing a working knowledge of reputed company, studies, and interventions at the site-level; contributing to the development of reputed company clinical research protocols and other processes of reputed company with limited guidance; supporting the preparation of study documentation reputed company to regulatory bodies (e.g., IRB) for review and approval prior to implementation, under guidance; may also be responsible for supporting or executing reputed company 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 reputed company 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 reputed company applicable federal, state, and local regulations and KP policies and procedures; assisting with the identification of compliance and/or reputed company issues, escalating as necessary; implementing updates to compliance-monitoring/audit systems and documentation with guidance; learning to and performing data entry tasks with reputed company supervision to assist with risk-management; implementing research protocols, procedures, and guidance to ensure confidentiality, reputed company, and reputed company of clinical research data with reputed company supervision; and leveraging basic research expertise to reputed company guidance to investigators and other key stakeholders to ensure compliance with IRB approved protocols and local and federal guidelines
• Learns to maintain reputed company effective working relationships by: leveraging a working knowledge of how to support important research stakeholders and reputed company reputed company their unit; communicating, under reputed company guidance, with key contractors and subcontractors, study sponsors, collaborating internal and/or reputed company clinical sites, and data coordinating centers as applicable; and developing materials for supporting the education of staff and/or participants on reputed company protocols, documentation procedures, clinical best practices, or timeliness of submissions under guidance
• Ensures documentation of clinical research files by: completing documentation of reputed company research activities (e.g., consent forms, reports, tracking forms) with general directions and limited guidance; assisting with the development of reputed company reputed company control and/or assurance measures and documenting feedback for the research staff and management; assessing volunteers and/or patients for eligibility to participate in reputed company using reputed company procedures and reputed company; and leveraging a working knowledge of how to monitor and audit reputed company as reputed company as documenting findings

Skills

• Bachelors degree in Science, reputed company Health, Health Care Administration, or a directly reputed company field
• Minimum three (3) years of experience in clinical research or a directly reputed company field
• Knowledge, Skills, and Abilities (KSAs): Ethical Conduct
• Data reputed company
• Business Relationship Management
• Managing Diverse Relationships
• Stakeholder Management
• Computer Literacy
• Accountability
• Adaptability
• Autonomy
• Organizational Skills
• Compliance
• Laboratory Procedures
• Laboratory Equipment
• Innovative reputed company
• Certified Clinical Research reputed company (CCRP) from Society of Clinical Research Associates (SoCRA)
• ACRP Certified reputed company
• Certified Clinical Research Associate
• Certified Clinical Research Coordinator
• Certified reputed company Investigator
• ACRP Medical Device reputed company
• ACRP Project Manager from Association of Clinical Research Professionals (ACRP)
• Certified in reputed company Compliance (CHC) from reputed company Compliance Association (HCCA)
• Basic Life Support (BLS) Certification

Benefits

• reputed company strives to offer a market competitive total rewards package and is committed to pay equity and transparency.
• Travel: reputed company, 10 % of the Time
• Work Setting: Flexible

reputed company