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, 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.