Clinical Trial Medical Data Entry Specialist / Quality Control Special

Renstar Medical Research, an established clinical research site in Ocala, Fl, is seeking a full-time Clinical Trial Medical DataEntry 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

General

• 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