Quality Control Associate

At K2 Medical Research, a privately-owned clinical research facility in the greater Orlando and Central Florida area, we specialize in conducting multiphasic clinical trials that promote the development of innovative and effective medical treatments while maintaining the safety and privacy of our participants. We are committed to fighting the diseases that plague our loved ones and ourselves. By harnessing the power of advanced clinical research and connecting our patients with the treatments of tomorrow, we can improve the health of our local communities, and by extent, the population of our world.

K2 is seeking a knowledgeable and detail-oriented Quality Control Associate to support our clinical research clinics in the greater Tampa, FL area. The 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. This is a hybrid position expected on site 75% of the time, and may work from home the remaining 25% of the time. The position will be required to travel, splitting their time between The Villages and Tampa sites. 

Primary Responsibilities:

• 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.
• Ensure all queries are responded to & resolved in a timely manner prior to Subject randomization and Sponsor monitoring visits.
• Work closely with the EDC department to make sure all clinical data entered in respective electronic systems are verified in a timely manner.
• Communicates compliance trends and reports significant quality issues to the Quality Assurance Department.
•  Assists in the tracking and reporting of compliance trends and metrics.
• Provides training as needed to Project Managers.
• Perform ad-hoc projects or other assigned duties on as needed basis.
• Other duties as assigned

Knowledge, Skills, Abilities:

• Strong judgment, planning, and organizational skills
• Ability to manage multiple tasks/projects simultaneously
• 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

Qualifications:

• 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.
• Must be willing to travel between The Villages and Tampa facilities. 
• Must be able to work in office at least 75% of the time. 

At K2, we value our employees and their professional and personal needs, and support these through our benefit offerings:

• 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.