Quality Control Associate

K2 Staffing • Tampa, FL

4d • Onsite

About The Position

K2 is seeking a Quality Control Associate to support our clinics out of Tampa, FL . The Quality Control (QC) Associate monitors and performs routine compliance checks on all source data in alignment with protocol requirements and in compliance with ICH-GCP, FDA Regulations, and K2 Medical Research SOPs.

Requirements

• 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
• Learn and support the mission and goals of K2 Medical Research's program
• Ability to communicate clearly/effectively (written and oral)
• Excellent interpersonal and customer services skills
• Bachelor’s Degree required
• Minimum 5 years of clinical research experience with at least 3 years of patient care experience.
• Applicants that don't meet 100% of the above qualifications but who have a combination of related education, applicable experience, demonstrated capability, and a genuine passion for success in this position may also be considered.

Nice To Haves

• CCRC and/or CCRP preferred.

Responsibilities

• Serving as a point of contact for K2 site(s) 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.
• Able to commute to assigned location(s) a minimum of once per week, or more, at the discretion of Quality Management.
• Meet monthly performance goals established for the QC Associate role.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level