QC & Data Entry Specialist (Clinical Research - Entry & Exp.)
Job Description
Job Description
About the Opportunity
A leading, multi-site clinical research organization is seeking a Quality Control Data Entry Specialist to join its growing team in Winter Park, FL. This is an exciting opportunity for a motivated, detail-oriented professional looking to contribute to life-changing research within a supportive, mission-driven environment.
The organization offers a competitive compensation package, comprehensive benefits, and a collaborative culture committed to professional growth and patient impact.
Position: Quality Control Data Entry Specialist
Location: Miami, FL 33135 (Little Havana)
Schedule: Monday–Friday, 8:00 AM – 4:30 PM
Employment Type: Full-time (on-site) - May be eligible for a hybrid schedule after 6 months.
Benefits Include:
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Health, dental, and vision insurance
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401(k) with 4% employer match
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Tuition reimbursement
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Parental leave
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Employee referral program
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Life and disability insurance
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15 days PTO + 10 paid holidays
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Employee assistance program
Role Overview
This position is responsible for ensuring the accuracy and completeness of patient files through detailed chart audits and data entry into a Clinical Trial Management System (CTMS). The role is ideal for candidates with strong attention to detail and a background in clinical settings or research quality.
Key Responsibilities
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Conduct thorough reviews of study charts in alignment with SOPs, GCP, GDP, and protocol guidelines
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Accurately and timely enter data into electronic case report forms (eCRFs/CRFs)
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Identify and escalate discrepancies, missing data, or documentation issues
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Collaborate with site teams and sponsor representatives to resolve data queries
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Participate in study initiation and monitoring activities, including SIVs
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Assist with onboarding and training of new team members
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Support sponsor monitor visits and audit readiness
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Perform other quality-related duties as assigned
Qualifications
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Must have at least 1 year of clinical research experience
OR
A medical background such as RN, LPN, MA, or similar certification -
Familiarity with patient data systems (e.g., CTMS)
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Knowledge of ICH, FDA, and GCP regulations preferred
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High attention to detail and strong organizational skills
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Effective communication and interpersonal skills
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Working knowledge of medical terminology
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Proficiency in Microsoft Office Suite
About the Organization
This organization is a nationally recognized leader in clinical research, with a diverse portfolio in therapeutic areas such as cardiology, metabolic disorders, CNS, pulmonology, and vaccines. It operates under a strong commitment to diversity, equity, and inclusion, striving to reflect and serve its local communities through excellence in clinical trials.
Employees are empowered to grow their careers while contributing to research that improves lives. The organization values transparency, teamwork, and a shared mission to advance healthcare outcomes.