[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 https://k2med.com.
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 Apply To this Job