Clinical Data Coordinator I

This is a fully remote position, open to applicants in United States.

📋 Description

• Extract clinical data from subject source documentation.

• Input clinical data into study-specific electronic data capture (EDC) case report forms.

• Ensure the accuracy of clinical data through thorough cleaning.

• Update the EDC upon verifying subject data, including resolving any data queries.

• Monitor site objectives and completion of case report forms.

• Prioritize site cases for detailed analysis.

• Maintain documentation specific to the study.

• Conduct quality control audits of the clinical database.

• Support and comply with Good Clinical Practices, FDA regulations, IRB guidelines, HIPAA standards, Site Operating Procedures, and ethical principles for clinical research trials.

• Collaborate closely with onsite teams to ensure that appropriate consent is obtained and documented prior to data abstraction.

• Manage source document organization and request information in accordance with Caris and site requirements.

• Serve as the designated data entry person for the site.

• Communicate effectively with the research team, investigators, Clinical Research Associates, study sponsors, and ancillary staff.

• Arrange onsite visits for data review and entry into the EDC.

⛳️ Requirements

• A minimum of 3-5 years of experience in data collection activities within a GCP and clinical research regulatory environment is required.

• Knowledge of essential components for success in clinical trials, including GCP, ICH guidelines, and the Code of Federal Regulations.

• Clinical study experience, particularly in the field of Oncology.

• Strong understanding of medical terminology.

• Experience in both small and large scale project planning and reporting, demonstrating strong communication and presentation abilities.

• Proven experience in training both internal and external staff, mentoring less experienced colleagues.

• Familiarity with EDC systems.

• Proficient in Microsoft Office Suite, especially Word, Excel, Outlook, and possess a general knowledge of the Internet for business purposes.

• Must have the ability to sit and/or stand for extended periods.

• Successful completion of the pre-employment process, which includes a criminal background check, drug screening, credit check (where applicable), and reference verification is required.

• Willingness to travel to multiple investigative sites as needed.

🏝️ Benefits

• Highly competitive and inclusive options for medical, dental, and vision coverage.

• Health Savings Account available for medical and dependent care expenses.

• Flexible Spending Account to cover certain out-of-pocket costs.

• Paid time off, which includes vacation, sick leave, and holidays.

• 401k matching and access to financial planning tools.

• Long-term and short-term disability insurance coverages, along with optional voluntary benefits.

• Employee Assistance Program.

• Pet insurance.

• Legal assistance.

• Tuition assistance.