Job Title: Clinical Research Associate – Clinical Monitor Location: San Diego, CA 92121 Work Arrangement: Hybrid – 50% in office and 50% onsite at clinical study sites, as applicable. Candidates should live within a reasonable commute distance. Number of Openings: 3 Duration: 7 Months Work Hours: 8 hours per day; schedules may vary depending on travel and project requirements. Dress Code: Business casual, especially when visiting clinical study sites. Parking: Free parking. Interview Process: Two-step interview process.
Job Description The client, located in San Diego, California, is an academic research institute 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 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.
Must-Haves
Minimum 2–3 years of Clinical Research Associate (CRA) experience.
Experience reviewing medical records and clinical trial documentation.
Strong attention to detail and accuracy.
Understanding of clinical trial monitoring and regulatory compliance.
Ability to conduct onsite and remote monitoring visits.
Nice-to-Haves
Experience conducting study closeout visits.
Investigational Product (IP) management and reconciliation experience.
Strong critical-thinking and problem-solving skills.
Proactive approach to identifying and resolving site issues.
Alzheimer's Disease (AD) clinical research experience.
Education and Experience
Education: Bachelor's degree in Healthcare, Health Administration, Biology, Psychology, or a related field. An equivalent combination of education and experience may be considered.
Experience: At least 2 years of relevant experience.
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
All reimbursements are subject to applicable limits and require receipts or proof of payment. 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 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.
Applicant Notices & Disclaimers
For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's pay range is $35.00/hr - $44.00/hr.
