LanceSoft, Inc. · 1 month ago
Assoc Clinical Research Spec - Exempt
Virtual, MN
Full-time
Hybrid
New Grad, Entry, Mid Level
$35/hr - $40/hr
0+ years expLanceSoft, Inc. is seeking an Associate Clinical Research Specialist to ensure compliance with clinical study safety and reporting. This role involves reviewing adverse events, collaborating with regulatory teams, and preparing safety reports.
Information Technology
Responsibilities
Review and assess clinical study Adverse Events (AEs) including Serious Adverse Events (SAEs) and device deficiencies
Interact with investigational sites and clinical monitors to gather additional pertinent information as indicated in the Clinical Investigation Plan (CIP)
Collaborate with Regulatory Affairs and Product Complaint Reporting teams to ensure timely reporting of AEs, SAEs, and Unanticipated Serious Adverse Device Effects (U[S]ADEs)
Author Clinical Safety Management and Potential Complaint Plan (CSMPCP) for assigned studies
Assist with preparation of safety reports for annual reports, clinical study reports, and other documents as required
Support study audits for Safety-specific topics and facilitate Clinical Event Committee (CEC) work
Prepare, attend, and/or lead Safety Trending meetings
Qualification
Required
Background in science, nursing, or medicine
Experience with RAVE and VAULT databases
Bachelor's degree required
0-5 years of experience in a related field
Preferred
Safety experience is a plus
Company
LanceSoft, Inc.
Established in 2000, LanceSoft is a pioneer in delivering top-notch Global Workforce Solutions and IT Services to a diverse clientele.
5001-10000 employees
H1B Sponsorship
LanceSoft, Inc. 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 (55)
2024 (32)
2023 (23)
2022 (25)
2021 (60)
2020 (80)
Funding
Current Stage
Late StageLeadership Team
Ram Karuppusamy
Chairman & CEO
Simon Dealy
Chief Financial Officer
Company data provided by crunchbase