Data Entry Specialist

IQVIA; San Antonio (TX); Vor Ort; USD 26.000 - 65.000; Vollzeit

Zusammenfassung

IQVIA is seeking a Data Entry Specialist to support clinical studies under the Director of Data Management. You will enter study data into the EDC system, ensure accuracy, and resolve data queries in collaboration with research coordinators.

Responsibilities include overseeing data entry from source documents to CRFs, reviewing patient records for completeness, and coordinating with sponsors and monitors. Familiarity with SOPs and regulatory guidelines is essential.

Qualifikationen

• High School Diploma is required.
• Associate degree or certificate program is preferred.
• Working knowledge of clinical research Electronic Data Capture (EDC) systems.
• Knowledge of ICH GCP, FDA, OHRP, OSHA and HIPAA guidelines pertaining to clinical research

Aufgaben

• Oversee data entry from source documents to the 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.

Kenntnisse

EDC systems

Interpersonal skills

Medical terminology

ICH GCP knowledge

Organizational skills

Prioritization

Multi-tasking

Team player

Communication skills

Ausbildung

High School Diploma

Associate degree or certificate

Jobbeschreibung

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.