Data Coordinator

Charter Research, LLC; Orlando, Northern (FL, KY); Hybrid; USD 45,000 - 60,000; Full time

Job summary

Charter Research, a clinical research company with a presence in Florida and Illinois and an Orlando base, seeks a Data Coordinator to ensure complete and accurate trial data entry into EDC systems and paper formats.

You will follow ICH-GCP guidelines, SOPs, and sponsor requirements while coordinating with the clinical team to improve training, processes, and data quality.

Qualifications

• Bachelor’s degree in a related field preferred.
• 1–3 years of related experience preferred.
• Knowledge of medical terminology preferred.

Responsibilities

• Adhere to ICH-GCP guidelines and Charter Research SOPs.
• Understand assigned studies via protocols and training, coordinating with Principal Investigator.
• Complete and maintain training mandated by sponsors, CROs, study vendors, and Charter Research.
• Adhere to study protocols and data entry standards using eCRF guidelines and data capture snapshots.
• Perform and track compliance reviews of source documentation, confirming informed consent and study eligibility per ALCOA-C standards.
• Maintain metrics related to volume, timeliness, and accuracy of data collection and entry.
• Communicate data issues with the Clinical Research Coordinator, Clinical Team Lead, Physician Investigator, Finance Associate and Clinic Manager.
• Collaborate with each study’s CRA to facilitate sponsor and CRO data monitoring and maintenance processes.
• Investigate and respond to data queries in a timely manner with the clinical research team.
• Prepare for and participate in quality compliance and quality assurance audits conducted by sponsors or regulators.
• Perform additional duties as assigned.

Skills

Interpersonal skills

Organizational skills

Verbal and written communication

Teamwork

Multitasking

HIPAA compliance

MS Office

Data entry systems

Education

Bachelor’s degree preferred

1-3 years of related experience preferred

Knowledge of medical terminology preferred

Tools

MS Office

EDC systems

Job description

COMPANY DESCRIPTION

Charter Research is a highly experienced and quickly growing clinical research company, based in Florida and Illinois that is looking to add to our team to help us fulfill our mission of discovering future medicines. Our company is locally owned and prides itself on providing exceptional patient experience to our participants, as well as offering agile recruitment strategies to our sponsors. Above all, we are a team, and we are seeking the right team member to add to our foundation in Orlando , FL.

POSITION OVERVIEW

The Data Coordinator is responsible for monitoring the completeness and accuracy of clinical trial datawhile entering subject source data into Electronic Data Capture (EDC) systems and paper formats.Individuals in this role ensure the timely entry of excellent quality data into data capture systems andprovide related feedback to the clinical research team to support continuous improvement of trainingand systems.

RESPONSIBILITIES

• 1. Adhere to International Council on Harmonization - Good Clinical Practice (ICH-GCP) guidelinesand Charter Research Standard Operating Procedures (SOPs).
• 2. Understand thoroughly all assigned studies through reading protocols, attending start-upmeetings, and related training, and coordinating with Principal Investigator.
• 3. Complete and maintain all training mandated by sponsors, Contract Research Organizations(CROs), study vendors, and Charter Research.
• 4. Adhere strictly to the study protocols and their associated data entry standards, utilizing theElectronic Case Report Form (eCRF) guidelines and data capture snapshots provided by thesponsor, CRO, and EDC vendor.
• 5. Performs and tracks compliance reviews of source documentation, confirming documentation ofinformed consent processes, study eligibility, and data capture in compliance with ALCOA-Cstandards.
• 6. Maintain metrics related to volume, timeliness, and accuracy of data collection and entry to beused in analyzing efficiencies and identifying opportunities for improvement.
• 7. Communicate issues with clinical study data to the appropriate Clinical Research Coordinator,Clinical Team Lead, Physician Investigator, Finance Associate and Clinic Manager.
• 8. Work closely with each assigned study’s Clinical Research Associate (CRA) to facilitate thesponsor and CRO data monitoring and maintenance processes.
• 9. Investigate and respond to all data queries in a timely manner in collaboration with members ofthe clinical research team.
• 10. Prepare for and/or participate in quality compliance and quality assurance audits conducted bystudy sponsors, federal agencies, or other review groups.
• 11. Perform additional duties as assigned.

KNOWLEDGE, SKILLS, AND ABILITIES

• 1. Excellent interpersonal and customer service skills.
• 2. Exceptional organizational skills and attention to detail.
• 3. Strong verbal and written communication skills.
• 4. Ability to work well both independently and as part of a team.
• 5. Ability to handle multiple tasks simultaneously and adapt to changes in workload.
• 6. Must possess a high degree of integrity and the ability to maintain confidentiality with HIPAAguidelines, patient matters, and other sensitive information.
• 7. Experienced in the use of computers, including both Microsoft Office and data entry systems.

QUALIFICATIONS

Education & Experience

• 1. Bachelor’s degree preferred – preferably in psychology, biology, health sciences, or a relatedfield.
• 2. 1-3 years of related experience preferred.
• 3. Knowledge of medical terminology preferred.

PHYSICAL REQUIREMENTS

• Prolonged periods of sitting at a desk and working on a computer.

Charter Research provides equal employment opportunity (EEO) to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability status, genetic information, marital status, ancestry, protected veteran status, or any other characteristic protected by applicable federal, state, and local laws.