Clinical Trial Data Entry Specialist

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

Renstar Medical Research is a research site located in beautiful North Central Florida, one of the fastest growing retirement areas in the country. Renstar’s research staff work with local physicians in private practice and community hospital settings to provide a multidisciplinary team focused on meeting enrollment goals while ensuring strict regulatory and protocol compliance.
Renstar has streamlined its trial initiation and enrollment processes by designing proprietary software for protocol tracking. This computerized system ensures efficient submission of regulatory documents and superior internal tracking of protocols, and study progress. Renstar is staffed with dedicated research professionals who have a proven track record for quickly enrolling appropriate study patients.
Renstar is committed to the performance of ethical, high quality studies in all fields of clinical medical research. Renstar currently uses an independent reviewer who conducts regular audits of its procedures and data. In addition, Renstar has developed its own set of Standard Operating Procedures (SOPs), to ensure that high standards are maintained.
 

In order to respond quickly to a sponsor’s inquiries, Renstar utilizes a proprietary data management system. This system provides Renstar staff and study sponsors with timely information in the following areas:

• Historical and current study enrollment information
• Investigator research experience and expertise
• Study initiation and enrollment information
• Patient demographics and medical history information
• Full-time recruitment specialists design outreach campaigns customized to each protocol and patient population. These campaigns take advantage of Renstar’s extensive research participant database, and also reach out to new participants through a variety of traditional and digital media channels.
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