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Clinical Research Associate
2 months ago
Company Overview
K2 Staffing LLC is a leading provider of clinical research services, dedicated to advancing medical treatments and improving patient outcomes. Our team of experts is committed to delivering high-quality research solutions that meet the needs of our clients and the medical community.
Job Summary
We are seeking a detail-oriented and knowledgeable Quality Control Associate to join our team. The successful candidate will be responsible for monitoring and performing routine compliance checks on all source data, ensuring adherence to protocol requirements, ICH-GCP, FDA Regulations, and K2 Medical Research SOPs.
Key Responsibilities
- Source Document Review
- Verify subjects meet Inclusion/Exclusion criteria per protocol requirements to verify eligibility prior to randomization.
- Review source documents to confirm adherence to organization policies, procedures, and best practices.
- Query Creation and Resolution
- Create queries for the Project Managers to address missing or incomplete source records or to clarify requirements in the source records.
- Ensure all queries are responded to and resolved in a timely manner prior to Subject randomization and Sponsor monitoring visits.
- Collaboration and Communication
- Work closely with the EDC department to ensure all clinical data entered in respective electronic systems are verified in a timely manner.
- Communicate compliance trends and reports significant quality issues to the Quality Assurance Department.
- Training and Support
- Assist in the tracking and reporting of compliance trends and metrics.
- Provide training as needed to Project Managers.
Requirements
- Bachelor's Degree required; CCRA and/or CCRP preferred.
- Minimum 3 years of clinical research experience with at least 2 years of patient care experience.
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.
