National Association of Latino Healthcare Executives ยท 11 hours ago
Clinical Research Coordinator II, Clinical Trials
Oakland, CA
Full-time
Onsite
New Grad, Entry LevelThe National Association of Latino Healthcare Executives is looking for a Clinical Research Coordinator II to support clinical trials research. This role involves collecting data, preparing study documentation for regulatory bodies, and assisting with clinical trials activities and lab operations while ensuring compliance with regulations.
Health CareHospitalMedical
Responsibilities
Pursues effective relationships with others by sharing resources, information, and knowledge with coworkers and members. Listens to, addresses, and seeks performance feedback. Pursues self-development; acknowledges strengths and weaknesses based on career goals and takes appropriate development action to leverage / improve them. Adapts to and learns from change, challenges, and feedback; demonstrates flexibility in approaches to work. Assesses and responds to the needs of others to support a business outcome
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. Collaborates with others to solve business problems; escalates issues or risks as appropriate; communicates progress and information. Supports the completion of priorities, deadlines, and expectations. Identifies and speaks up for ways to address improvement opportunities
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
Qualification
Required
Collects data for clinical trials research, following general directions
Supports the preparation of study documentation for submission to regulatory bodies (e.g., IRB) for pre-implementation review and approval
May support clinical trials activities and research lab operations
Completes timely and accurate documentation of all research activities (e.g., consent forms, reports), with limited guidance
Assists with the development and/or implementation of standard quality control and/or assurance measures and documents feedback to research staff and management
Supports and develops materials for the education of research staff and/or participants on standard protocols, documentation procedures, clinical best practices, or timeliness of submissions, under guidance
Learns about providing input on implementing budgeting components for internally funded standard projects
Learns to draft and submit clinical trials applications, under guidance, in compliance and consistency with all applicable federal, state, and local regulations and KP policies and procedures
Pursues effective relationships with others by sharing resources, information, and knowledge with coworkers and members
Listens to, addresses, and seeks performance feedback
Pursues self-development; acknowledges strengths and weaknesses based on career goals and takes appropriate development action to leverage / improve them
Adapts to and learns from change, challenges, and feedback; demonstrates flexibility in approaches to work
Assesses and responds to the needs of others to support a business outcome
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
Collaborates with others to solve business problems; escalates issues or risks as appropriate; communicates progress and information
Supports the completion of priorities, deadlines, and expectations
Identifies and speaks up for ways to address improvement opportunities
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
Company
National Association of Latino Healthcare Executives
The National Association of Latino Healthcare Executives is a hospital and healthcare organization.
Founded in 2005
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Jackie Sifuentes, MBA, LSSYB
Co-Founder La Mesa Emerging Leaders Mentorship Program for Early Careerists
Company data provided by crunchbase