Job Description
Job Summary:
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.
Essential 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.
Knowledge, Skills and Abilities: (Core)
- Ambiguity/Uncertainty Management
- Attention to Detail
- Business Knowledge
- Communication
- Critical Thinking
- Cross-Group Collaboration
- Decision Making
- Dependability
- Diversity, Equity, and Inclusion Support
- Drives Results
- Facilitation Skills
- Health Care Industry
- Influencing Others
- Integrity
- Learning Agility
- Organizational Savvy
- Problem Solving
- Short- and Long-term Learning & Recall
- Teamwork
- Topic-Specific Communication
Knowledge, Skills and Abilities: (Functional)
- Accountability
- Adaptability
- Autonomy
- Business Relationship Management
- Compliance
- Computer Literacy
- Data Quality
- Innovative Mindset
- Laboratory Equipment
- Laboratory Procedures
- Managing Diverse Relationships
- Organizational Skills
- Research Ethics
- Stakeholder Management
Minimum Qualifications:
- Bachelors degree in Science, Public Health, Health Care Administration, or a directly related field OR Minimum three (3) years of experience in clinical research or a directly related field.
Preferred Qualifications:
- Master's degree in Public Health, Health Care Administration, Epidemiology, Health Sciences, Social or Behavioral Sciences, Health Services, Statistics, or Health Economics, or related field.
Primary Location: California,Oakland,Oakland Mosswood Medical Offices
Scheduled Weekly Hours: 40
Shift: Day
Workdays: Mon, Tue, Wed, Thu, Fri, Sat, Sun *Schedule varies based on department needs.
Working Hours Start: 08:00 AM
Working Hours End: 04:30 PM
Job Schedule: Full-time
Job Type: Standard
Worker Location: Onsite
Employee Status: Regular
Employee Group/Union Affiliation: NUE-NCAL-09|NUE|Non Union Employee
Job Level: Individual Contributor
Department: Oakland Reg - 2000 Broadway - RI Medical Records_Recharge - 0201
Pay Range: $31.39 - $40.61 / hour Kaiser Permanente is committed to pay equity and transparency. The posted pay range is based on possible base salaries for the role and does not include the value of our total rewards package. Actual pay determined at offer will be based on years of relevant work experience, education, certifications, skills and geographic location along with a review of current employees in similar roles to ensure that pay equity is achieved and maintained across Kaiser Permanente.
Travel: No
On-site: Work location is on-site (KP designated office, medical office building or hospital). Worker location must align with Kaiser Permanente's Authorized States policy. Kaiser Permanente is an equal opportunity employer committed to fair, respectful, and inclusive workplaces. Applicants will be considered for employment without regard to race, religion, sex, age, national origin, disability, veteran status, or any other protected characteristic or status.
Job Tags
Full time, Temporary work, For contractors, Work experience placement, For subcontractor, Work at office, Local area, Shift work,