Mindlance · 5 months ago
Clinical Research Assocoate
San Diego, CA
Full-time
Onsite
Entry, Mid Level
$40/hr - $45/hr
2+ years expMindlance is a confidential company seeking a Clinical Research Associate (CRA) to support Study Leads in clinical study planning, execution, and management. The role involves ensuring compliance with clinical protocols and regulatory requirements while assisting in various study-related tasks and responsibilities.
Human Resources
Responsibilities
Support assigned study teams with TMF set-up, maintenance, ongoing quality control reviews, and final reconciliation of study documents
Routinely monitor TMF inspection readiness for assigned studies
Assist Study Lead with investigational product and ancillary supplies management, accountability and reconciliation activities
Collect and/or review Essential Documents from investigational sites
Review informed consent documents for accuracy and completeness
Support investigator identification, feasibility, and activation activities
Review monitoring visit reports for accuracy and completeness
Support Study Lead in preparing materials for study-wide meetings (eg investigator meetings, interim update meetings, data safety committee meetings, etc.)
Perform QC (formatting, spelling and grammar, accuracy, consistency) of study-level documents (master ICFs, study plans, manuals, CRFs/CRF completion instructions, etc.) in alignment with study protocols
Contribute to the development of study-level documents ( study templates, manuals, guides, newsletters, etc.)
Provide updates on study/site status as needed to ensure timely study entry and updates are reflected on ClinicalTrials.gov or equivalent
Perform periodic data reviews as requested by Study Lead
Prepare and present updates at team meetings as assigned by Study Lead
Support central/referral laboratory set-up and on-time activation (eg specifications, user manual) as delegated by the Study Lead
Work closely with CRO to plan for execution of study start-up and ongoing study execution activities as assigned by the Study Lead
Provide guidance and training to junior level team members as assigned by management
Recommend modifications to SOPs/work instructions (WIs) when necessary to improve compliance or efficiency
Participate in process improvement projects including SOP/WI development
Maintain compliance with assigned procedures, guidelines, study plans and applicable regulatory requirements
Qualification
Required
2 years in clinical research
1 year onsite monitoring/site management experience
Experience managing/supervising vendors preferred
Highly proficient knowledge and understanding of ICH-GCP
Preferred
4-year college degree
CRA certification
Company
Mindlance
Mindlance is a Staffing and Recruiting company which provides multi-vertical staffing services
1001-5000 employees
H1B Sponsorship
Mindlance has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (71)
2024 (53)
2023 (37)
2022 (72)
2021 (36)
2020 (40)
Funding
Current Stage
Late StageLeadership Team
R
Rajat Paul Dhall
Co-Founder & Managing Director
V
Vik Kalra
Co-Founder and Managing Director
Recent News
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