Data Coordinator

COMPANY DESCRIPTIONCharter Research is a highly experienced and quickly growing clinical research company, based inFlorida and Illinoisthat 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 inThe Villages, 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 studys 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 ...