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Clinical Trial Medical Data Entry Specialist / Quality Control Special

Renstar Medical Research
Ocala, FL
  • Posted: over a month ago
  • Full-Time
  • Benefits: 401k, dental, medical, vision,
Job Description

Renstar Medical Research, an established clinical research site in Ocala, Fl, is seeking a full-time Clinical Trial Medical Data Entry Specialist / Quality Control Specialist. 

Knowledge, Education, and Experience

  • Knowledgeable and prior work history involving medical terminology, medical conditions, and an understanding of medications
  • Medical transcription experience a plus
  • Able to communicate with co-workers, sponsors, and other professionals in the pharmaceutical research field in a collaborative and courteous manner
  • Able to initiate or modify behavior to achieve desired outcomes in spite of environmental factors, priorities, or problems that might not be well defined or that are subject to change


  • Perform Quality Assurance and Control to maintain audit readiness of studies
  • Ensures all study related communication is documented and identify any areas that need further clarification or inconsistencies to the Site Director
  • Coordinates with site staff, vendors, and contract employees to obtain quality data
  • Review Source Documents, CRF's, Study Documents, Logs, and Master Files with coordinators and staff to ensure quality, completeness, and accuracy
  • Reviews consent documents on assigned trials and source documents
  • Compiles review sheets for each CRF reviewed, which includes the error, a description of the correction (if necessary), and the name of the coordinator who is to make the correction
  • Completing simple reports and reporting quality trends to management
  • The creation of subject charts for coordinators
  • Works closely with monitors to facilitate timely turnaround of study queries and data entry
  • Reviews monitor follow-up letters and ensure outstanding issues are resolved
  • Assists and coordinates monitor corrections
  • Prepare for audits and inspections as needed
  • Comply with the confidentiality of research data
  • Has a working knowledge of GCP/ICH guidelines, clinic SOPs and individual protocols
  • Performs other duties as assigned
  • Always represents research site in a professional manner when interacting with sponsors, volunteers, outside venders and fellow employees

Skills and Abilities

  • Excellent communication skills (interpersonal, written, verbal)
  • Must be able to identify and communicate about research problems and processes across various levels of the organization
  • Good organizational and interpersonal skills
  • Attention to detail
  • Must be self-motivated and able to perform tasks independently
  • Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry

Renstar Medical Research


21 NE 1st Ave Ocala

Ocala, FL



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