Document Control Associate Jobs in New Port Richey, FL

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, and we'll ensure you have everything you need to shine.