K2 Medical Research · 11 hours ago
QUALITY CONTROL ASSOCIATE (100% REMOTE)
United States
Full-time
Remote
Mid, Senior Level
5+ years expK2 Medical Research is seeking a Quality Control Associate to support their clinics in a fully remote capacity. The role focuses on ensuring compliance and quality during post-randomization visits, including conducting spot checks and assisting with audits.
Clinical TrialsHealth CareHealth DiagnosticsMedical
Responsibilities
Must complete 100 visit spot checks per week
Assist with audit preparation and onsite audit assistance as requested by Quality Management
Site coverage (pre rand QC logs, spot checks, SAE review) if site associate is on PTO or influx in routine chart QC requests as requested by Quality Management
Provides support across all K2 clinics. All reviews will be conducted through the designated electronic source platform
Provides remote support to all clinics regarding quality related questions
Working closely with Quality Management to discuss quality concerns and collaborate resolutions for sites
Review of source documents to verify subjects meet Inclusion/Exclusion criteria per protocol requirements to verify eligibility prior to randomization
Review of source documents to confirm adherence to organization policies, procedures and best practices
Create queries for the Project Managers to address missing or incomplete source records or to clarify requirements in the source records
Review of Investigator Site Files to ensure complete, accurate and meeting applicable regulatory requirements
Communicates compliance trends and reports significant quality issues to Quality Management in a timely manner
Assists in ensuring the site(s) are maintaining proper training documents required for GCP and SOP compliance and verifying via eReg
Assists in the tracking and reporting of compliance trends and metrics
Provides training to clinical research staff as needed on quality related procedures and best practices, at the discretion of Quality Management
Perform ad-hoc projects or other assigned duties on as needed basis
Meet monthly performance goals established for the QC Associate role
Perform ad-hoc projects or other assigned duties on as needed basis
Qualification
Required
Bachelor's Degree required
Minimum 5 years of clinical research experience with at least 3 years of patient care experience
Strong judgment, planning, and organizational skills
Ability to manage multiple tasks/projects simultaneously
Ability to work independently
In depth knowledge of applicable laws, regulations, and policies
Strong patient care background; familiar with medical terminology
Proficient with Microsoft Office
Ability to communicate clearly/effectively (written and oral)
Excellent interpersonal and customer services skills
Preferred
CCRC and/or CCRP preferred
Benefits
Medical, Dental, Vision, Flexible Spending Accounts, Employer paid Long-Term disability and Life Insurance, Short Term Disability, Accident and Critical Illness Insurance, Voluntary Life and Long-Term Care Insurance, Legal Shield, Employee Assistance Program, and various discount programs.
401(K) Plans- Traditional and Roth plans are available; 4% employer match that is immediately vested
PTO of 16 days per year, 17 days after the first year of FT employment
9 paid Holidays
K2 observes a four-day work week, Monday through Thursday, for full time employees. Fridays are non-working days unless required by business needs.
Company
K2 Medical Research
K2 Medical Research is a clinical research center that specializes in conducting clinical trials.
201-500 employees
H1B Sponsorship
K2 Medical Research 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 (1)
2024 (1)
2023 (1)
2022 (2)
Funding
Current Stage
Growth StageTotal Funding
unknownKey Investors
TPG
2024-06-17Private Equity
Leadership Team
Sean Stanton
Founder
Recent News
Providence Business News
2026-01-22
2025-01-09
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