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

• 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