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Database Architect
Los Alamitos, CA
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Research Data Manager Cancer and Blood Specialty Clinic - 1.6 Los Alamitos, CA Job Details Full-time From $25 an hour 11 hours ago Benefits Health insurance Dental insurance 401(k) Paid time off Vision insurance Qualifications Teamwork Clinical research High school diploma or GED Bachelor's degree Data management Public Health Clinical information systems Health Science Organizational skills Research regulatory compliance Clinical quality assurance standards Clinical documentation standards Full Job Description
DATA MANAGER JOB PURPOSE
The Data Manager is responsible for ensuring the accuracy, completeness, integrity, and audit readiness of clinical research data and source documentation across all assigned studies. This role supports research quality initiatives through source-to-EDC review, query management, protocol compliance oversight, internal quality review processes, and coordination with research staff to ensure compliance with sponsor, protocol, GCP, and site requirements. The Data Manager serves as a key resource in maintaining data quality standards, supporting inspection readiness, and identifying opportunities for workflow and process improvement within the research department.
ESSENTIAL JOB FUNCTIONS 1.
Perform source-to-EDC review and reconciliation to ensure accuracy, completeness, and consistency of clinical research data 2. Review research charts, source documents, and electronic medical records (EMR) for compliance with protocol requirements and documentation standards 3. Track, review, and assist with resolution of sponsor and CRO data queries in collaboration with CRCs and study staff 4. Identify data discrepancies, missing documentation, protocol deviations, and quality concerns and escalate appropriately 5. Assist with ensuring compliance with
GCP, ALCOA
principles, sponsor requirements, and internal SOPs 6. Support audit and inspection readiness activities, including internal quality reviews and preparation for sponsor monitoring visits 7. Maintain quality tracking logs, query metrics, deviation trackers, and other departmental quality oversight tools 8. Assist with review of adverse event documentation, visit documentation, eligibility documentation, and protocol-required source documentation for completeness and consistency 9. Monitor timeliness of data entry and query resolution across assigned studies 10. Collaborate with CRCs, regulatory staff, providers, pharmacy, and research leadership to improve workflow efficiency and research quality standards 11. Participate in development and implementation of process improvements, quality initiatives, and departmental best practices 12. Assist with training and guidance related to documentation quality and research compliance standards as needed 13. Maintain confidentiality of patient, study, and organizational information at all times 14. Perform additional duties and special projects as assigned
QUALIFICATIONS AND EXPERIENCE 1.
Education a. Bachelor's degree in Life Sciences, Biology, Public Health, Health Sciences, Nursing, or related field preferred 2. Experience a. Minimum of 3 years of clinical research experience required b. Prior experience in oncology clinical research strongly preferred c. Experience with EDC systems, query management, and source documentation review required d. Experience supporting sponsor monitoring visits, audits, or inspection readiness activities preferred e. Strong understanding of
GCP, ALCOA
principles, protocol compliance, and clinical research documentation standards required f. Experience working with electronic medical records (EMR) systems required; CureMD experience preferred 3. Knowledge, Skills, & Abilities a. Strong attention to detail and organizational skills b. Ability to identify discrepancies, inconsistencies, and documentation gaps c. Strong analytical and problem-solving abilities d. Ability to manage multiple studies and priorities in a fast-paced environment e. Strong written and verbal communication skills f. Ability to work independently while collaborating effectively with cross-functional teams g. Proficiency in Microsoft Office, including Excel and Outlook
WORKING CONDITIONS AND PHYSICAL REQUIREMENTS 1.
Primarily office and clinical research environment 2. Frequent use of computer systems, EMR, EDC systems, and standard office equipment 3. May require prolonged periods of sitting, standing, typing, and reviewing electronic and paper documentation 4. Ability to occasionally move or lift files and office materials up to 15 pounds 5. May require travel between clinic locations as needed 6. Ability to maintain focus and accuracy in a fast-paced, deadline-driven environment
DIRECT REPORTS 1.
This position does not have direct supervisory responsibilities but may assist with training, workflow guidance, and quality oversight activities for research staff as directed by leadership.
Pay:
From $25.00 per hour
Benefits:
401(k) Dental insurance Health insurance Paid time off Vision insurance
Education:
High school or equivalent (Preferred)
Experience:
Data management: 1 year (Preferred) Clinical research: 1 year (Preferred)