[Remote] QUALITY CONTROL ASSOCIATE (100% REMOTE)

Note: The job is a remote job and is open to candidates in USA. K2 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. 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 Skills • 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 • 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 Overview • K2 Medical Research is a clinical research center that specializes in conducting clinical trials. It was founded in 2021, and is headquartered in Orlando, Florida, USA, with a workforce of 201-500 employees. Its website is Company H1B Sponsorship • K2 Medical Research has a track record of offering H1B sponsorships, with 1 in 2025, 1 in 2024, 1 in 2023, 2 in 2022. Please note that this does not guarantee sponsorship for this specific role. Apply tot his job