Data Entry Coordinator II

Job highlights:

The Data Entry Coordinator II is responsible for the submission of all clinical trial data, ensuring the accuracy and integrity of files, while performing quality control on the data gathered, and evaluating its compliance with ALCOA+ standards.

Informs Principal Investigator and study coordinators about the status of the clinical database, guaranteeing database lock readiness and completeness. All duties are carried out in accordance with the company policies, SOPs, and Good Clinical Practice (GCP) as well as all applicable Local, State, and Federal regulations.

Job functions:

• Critically evaluates clinical data for accuracy and completeness, while ensuring the safety and confidentiality of participants, according to the study monitoring plans.
• Submits research data into Electronic Data Capture systems (EDC) within the established timelines.
• Resolves and escalates queries to the research team.
• Performs data-related corrections in eCRFs when applicable.
• Periodically performs quality control of EDC systems focused on data integrity/accuracy and database lock readiness.
• Proofreads and verifies data entered.
• Scan, redact, and upload source documents to the Site File Repository.
• Updates internal Database and generates reports using dedicated software (Trust).
• Assists Clinical Research Coordinators in the creation of source documents, identifying discrepancies or missing data, based on EDC requirements, blank eCRFs, and EDC Guidelines.
• Provide updates on the status of all data entry-associated tasks to the Data Entry Manager.
• Process electronic medical records and update the Trust system.
• Perform quality control on the data gathered by the Clinical Team, evaluating its completeness, accuracy, and compliance with ALCOA+ standards, as well as the requirements set forth by the Sponsor. Additionally, ensure adherence to the Study Protocol and associated Guidelines.
• Create and document queries and findings in the Trust system arising from data reviews performed for future analysis and retraining as necessary.
• Notify the Data Entry Manager of significant findings from the collected subject data that may greatly impact the quality and integrity of the data.
• Upload the laboratory results to the Trust system for review by the clinical team and the Investigators.
• Completes additional tasks as required by specific study protocols or as assigned by the Data Entry Manager.
• This position reports to the Data Entry Manager.

Desired qualifications:

• Works well in a team environment.
• Familiarity with Clinical Terminology preferred.
• Excellent written and verbal communication skills.
• High attention to detail and organization.
• Clinical Research experience preferred.
• Bi-lingual English/Spanish required.
• Ability to work after hours and weekends if needed.
• Knowledge of Microsoft Office 365.
• Ability to type 40+ WPM with complete accuracy and proficiency.

Minimum requirements:

• A high school diploma or equivalent is required, and relevant formal academic/vocational qualification, as well as an associate degree in a medical or information technology field, is preferred.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years) or equivalent combination of education, training, and experience.

Work schedule:

• Monday to Friday – 8:00 am – 4:30 pm, unless otherwise indicated.
• Work Location: 3700 West 12 Ave Suite 300, Hialeah, FL 33012
• Company’s website: www.indagoresearch.org
• Work Remotely: No

Salary and benefits:

• Salary Range: $41,600 – $54,080/year.
• Health Insurance
• 401(k) & 401(k) matching plan
• Life insurance
• Paid time off
• Paid vacations
• Paid holidays
• Referral program
• Training/Professional development
• Certification reimbursement