Data Entry Specialist

IQVIA; Fairfax (VA); À distance; USD 26 000 - 65 000; Plein temps

Résumé du poste

IQVIA is seeking a data entry specialist to support clinical studies remotely. The role involves entering study data into EDC systems, resolving data queries, and ensuring CRF completeness in collaboration with the research team.

Responsibilities include reviewing patient records, meeting with monitors, and training junior staff. A high school diploma is required, with an associate degree preferred. This position emphasizes accuracy and regulatory adherence.

Qualifications

• High School Diploma required.
• Associate Degree and/or certificate program preferred.
• Knowledge of medical terminology.
• Knowledge of ICH GCP, FDA, OHRP, OSHA and HIPAA guidelines for clinical research.
• Excellent interpersonal skills to deal effectively with research personnel.
• Excellent organizational skills to independently manage workflow.
• Ability to prioritize quickly and appropriately with minimal guidance.
• Ability to multi-task.
• Ability to work independently and as part of a team.
• Clear and concise verbal and written communications.

Responsabilités

• Oversee and manage data entry from the source document to the CRF.
• Review patient records for completeness and accuracy.
• Meet with sponsor/monitors to review data entry.
• Provide backup coordination for monitoring visits.
• Resolve data queries promptly to ensure CRF completeness.
• Maintain data entry current for all studies per SOP.
• Comply with applicable ICH GCP, FDA, and HIPAA guidelines.
• Identify labs and lab certifications for study files.
• Communicate with accounts receivable staff regarding data submissions.
• Attend meetings and briefings on clinical studies.
• Guide and train less experienced staff.

Connaissances

Interpersonal skills

Organizational skills

Communication skills

Prioritization

Multi-tasking

Independent work

Data entry

Medical terminology

Formation

High School Diploma

Associate Degree / certificate

Outils

EDC systems

Description du poste

Job Location

This position is fully remote.

Job Summary

Under the direction and supervision of the Director of Data Management, this position is responsible for performing all data entry functions as they relate to the completion of case report forms, by entering study data collected by the research team into the Electronic Data Capture (EDC) system. Data entry personnel will also resolve all data queries. The position works closely with the research coordinators in support of all ongoing clinical studies.

Essential Duties and Responsibilities

Essential and other important responsibilities and duties may include but are not limited to the following:

• Oversee and manage the data entry from the source document to the case report form(CRF)
• Reviews patient records for completeness and accuracy
• Meets with sponsor/monitors to review data entry
• Serves as a backup to help coordinate and schedule monitoring visits
• Serves as a backup to provide support and information to monitors as necessary and as directed by supervisor(s)
• Timely resolution of data queries promptly to insure completeness of CRFs
• Assures that data entry remains current for all studies per SOP
• Complies with all applicable regulations, guidelines and procedures pertaining to dataloading, EDC and clinical research
• Identifies lab facilities used for studies so that lab certifications can be requested for study files
• Reviews and utilizes protocols as guides for study activities
• Communicates as needed with accounts receivable staff regarding submitted data
• Attends meetings and briefings regarding clinical studies as required
• Ability to assist in the guidance and training of less experienced staff
• Ability to maintain a positive attitude with the research team
• Maintain professional demeanor with sponsors, monitors, and auditors
• Remains current with all required training
• Performs other duties as assigned

Knowledge, Skills and Abilities

• Working knowledge of clinical research Electronic Data Capture (EDC) systems
• Excellent interpersonal skills to deal effectively with research personnel
• Knowledge of medical terminology
• Knowledge of ICH GCP, FDA, OHRP, OSHA and HIPAA guidelines pertaining to clinical research
• Excellent organizational skills to independently manage workflow
• Ability to prioritize quickly and appropriately with minimal guidance
• Ability to multi-task
• Ability to work independently and function as part of a team
• Clear and concise verbal and written communications

Required Education and Experience

• High School Diploma required
• Associate Degree and/or certificate program preferred

Why Join Us?

At NEXT Oncology (an Avacare Business), you’ll be part of a mission-driven team that values collaboration, precision, and patient safety. Our team is known for its supportive culture, strong communication, and commitment to excellence in clinical research.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is $25,900.00 - $64,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.