Job detail

Quality control associate

K2 Staffing LLC

#Compliance #Quality Control #Training #Regulatory Requirements #Patient Care #Medical Terminology #Microsoft Office #FDA Regulations #SOPs #Clinical Research #CCRC #Protocol Requirements

Full Time Hybrid 5-10 yrsPosted 5 months ago

Location (2)

Lake County, Florida

Locations

2 listed locations

Lake County, FloridaTampa, Florida

Quick overview

The Quality Control Associate monitors and performs routine compliance checks on all source data according to protocol requirements and regulatory standards like ICH-GCP and FDA Regulations. Key duties include reviewing source documents for eligibility verification, confirming adherence to organizational policies, and serving as a quality point of contact for sites.

Requirements summary

A Bachelor’s Degree is required, along with a minimum of 5 years of clinical research experience, including at least 3 years of patient care experience. Strong organizational skills, knowledge of applicable regulations, and proficiency with medical terminology and Microsoft Office are necessary.

bachelor degreeInterpersonal SkillsCommunicationOrganizational SkillsTrainingMedical TerminologyMicrosoft OfficeTask ManagementEligibility VerificationSOPsFDA RegulationsCompliance ChecksICH-GCP

Job description

K2 is seeking a Quality Control Associate to support our clinics out of The Villages and Tampa, FL. This position is hybrid with support needed one day out of each week at The Villages, the other day out of Tampa, 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.

Primary 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.

Knowledge, Skills, Abilities

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

Qualifications

Bachelor’s Degree required; CCRC and/or CCRP preferred.
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.

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.

Join the K2 Family

Where Compassion and Connection Lead the Way! At K2 Med, people come first and we're seeking warm, wonderful humans who effortlessly click with everyone, from our incredible patients to brilliant physicians and dedicated research staff. We thrive on empathy, a patient-first approach, and absolutely zero big egos (unless it's an ego about being extra kind, then we'll allow it!). We believe a supportive, caring experience is paramount for our patients, and that starts with you.

We celebrate what makes you uniquely you! Your race, color, religion, marital status, age, national origin, or even your favorite snack (though we're partial to good research snacks) don't define your talent or fit here. If you need a little extra support or accommodation due to a disability, no sweat! Just reach out to our friendly team at HR@k2med.com, [HR@k2med.com] and we'll ensure you have everything you need to shine.