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Clinical Research Associate – Clinical Monitor
Apolis
- 🇺🇸 United States
- On-site
- 1 day ago
- $1 – $44 / hour
- GCP
1 day ago
Not enough detail in this posting to match
Job Location:San Diego, CA 92121
Job Duration:7 months – possiblle extension
Work Arrangement:Hybrid – 50% in office and 50% onsite at clinical study sites, as applicable.
Travel Requirements and Reimbursement
This role will require travel to various locations throughout the United States.
Important: At this time, the specific travel locations have not yet been determined. Travel destinations will depend on project needs, and additional details will be shared as they become available.
Out-of-Town Travel
When travel is required, the following expenses may be reimbursed:
- Airfare
- Uber or other approved ground transportation
- Hotel accommodations
- Meals during business travel
Local Travel
- Mileage: When using a personal vehicle for project-related travel, mileage reimbursement is available for eligible travel exceeding 50 miles.
- Parking: Required parking fees associated with project visits will be reimbursed.
- Mileage Calculation: Reimbursable mileage is calculated from the ATRI office to the assigned project site.
- Commuting Exclusion: Mileage reimbursement does not apply to regular commuting between the employee's home and assigned work location.
All reimbursements are subject to applicable limits and documentation requirements.
Job Description
The academic research institute, located in San Diego, California, is comprised of scientific collaborators dedicated to advancing the development of new treatments for Alzheimer's disease through innovative clinical trials. The Clinical Research Associate – Clinical Monitor will oversee clinical trial activities at assigned study sites, ensuring studies are conducted, documented, and reported in compliance with study protocols, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and applicable regulatory requirements.
Key Responsibilities
- Conduct onsite and remote monitoring visits, including co-monitoring activities at assigned clinical study sites.
- Review Investigator Site Files, study data, Informed Consent Forms, and other essential clinical trial documentation.
- Perform Investigational Product (IP) reconciliation and other required monitoring activities.
- Ensure clinical study sites comply with GCP, regulatory requirements, study protocols, and ATRI policies.
- Identify, document, and follow up on protocol deviations and compliance concerns.
- Review clinical study data, issue and resolve queries, and verify inclusion and exclusion criteria for study participants.
- Conduct monitoring reviews of electronic Case Report Forms (eCRFs) to ensure data accuracy, participant safety, and protocol compliance.
- Serve as the primary point of contact for assigned clinical study sites.
- Maintain a thorough understanding of study protocols, procedures, and manuals.
- Collaborate with the Lead Clinical Monitor/Lead CRA to escalate site compliance issues.
- Participate in monitoring activities to support study milestones and timelines.
- Utilize internal systems and study-specific software and tools.
- Assist with training new clinical monitors on study-specific procedures and onsite monitoring processes.
- Participate in sponsor, internal, and regulatory audits as needed.
- Support electronic Trial Master File (eTMF) documentation and filing activities.
- Experience in Alzheimer's Disease research is preferred.
Clinical Research Associate – Clinical Monitor · Apolis