Quality Control Associate
About The Position
At K2 Medical Research, we are transforming healthcare by delivering tomorrow’s treatments today. As a rapidly growing clinical research organization across Florida, Tennessee, and Rhode Island, we lead multiphasic trials in therapeutic areas ranging from neurodegenerative to cardiometabolic medicine. Our culture is grounded in clinical excellence and a patient-first mission. We are seeking mission-driven individuals ready to play a meaningful role in bringing life-changing treatments to the patients who need them most. K2 is seeking a Quality Control Associate to support our clinic out of The Villages, FL. This position is hybrid with support needed one to two days out of the week at The Villages clinic, and remaining days remote. 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
- Bachelor’s Degree required
- Minimum 5 years of clinical research experience
- 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
- 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
Nice To Haves
- CCRC and/or CCRP preferred
- 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.
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, and vision options
- supplemental insurance plans
- 401(k) with immediate employer match
- generous paid time off
- paid holidays
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
