Data Entry Clinical Research

Job Description

The Data Entry Coordinator is responsible for the submission of all clinical trial data, ensuring accuracy and integrity of files. Keeps track of received subject visits data and enters it into the Electronic Data Capture systems within the agreed time frame. 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.
• 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.
• Create and document queries and findings in the Trust system arising from datareviews performed for future analysis and retraining as necessary.
• Notify the Data Entry Manager of significant findings from the collected subjectdata that may greatly impact the quality and integrity of the data.
• Upload the laboratory results to the Trust system for review by the clinical teamand the Investigators.
• Completes additional tasks as required by specific study protocols or as assignedby 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.

Qualifications

Skills

• Must have high attention to detail and accuracy with the ability to read and follow instructions.
• Excellent communication, interpersonal and organizational skills.
• Demonstrated understanding of HIPAA confidentiality regulations.
• Demonstrated understanding of medical terminology.
• Proficient computer skills including proficient keyboarding skills and experience in using Microsoft Office products, electronic mail and/or electronic health information records systems.
• Ability to work independently and collaboratively within a team environment.
• Demonstrated strong problem solving skills including the ability to handle difficult situations. Ability to prioritize workload and work under pressure in a fast-paced environment with time constraints.

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 required.
• Bi-lingual English/Spanish preferred.
• Ability to work after hours and weekends if needed.
• Knowledge of Microsoft Office 365.
• Ability to type 40+ WPM with complete accuracy and proficiency.

Education/Experience

• A Bachelor degree or equivalent is required, and relevant formal academic/vocational qualification, and/ or 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.
• Experience in medical coding.
• Experience in word processing, spreadsheets, databases systems, and Microsoft Office required.

Work schedule:

• Monday to Friday – 8:00 am – 4:30 pm, unless otherwise indicated

Benefits offered:

• Medical, Dental, and Vision Insurance
• Life Insurance (includes Will Preparation, Employee Assistance Program (EAP), and Travel Assistance)
• Short & Long-Term Disability
• Workers’ Compensation Insurance
• COBRA Continuation Coverage
• 401(k) Retirement Savings Plan with employer match
• Paid Time Off (PTO)
• Paid Holidays
• Bereavement Leave
• Family and Medical Leave Act (FMLA)
• Military Leave
• Referral Program
• Tuition Assistance/Professional Development
• Certification Reimbursement

Job Type: Full-time

Pay: $20.00 - $26.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Professional development assistance
• Referral program
• Vision insurance

Experience:

• Clinical research: 2 years (Preferred)

Work Location: In person