Charter Research is a highly experienced and quickly growing clinical research company, based in TheVillages and Orlando, FL 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.
POSITION OVERVIEW
The Data Coordinator is responsible for monitoring the completeness and accuracy of clinical trial data while 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 and provide related feedback to the clinical research team to support continuous improvement of training and systems.
RESPONSIBILITIES
Adhere to International Council on Harmonization - Good Clinical Practice (ICH-GCP) guidelines and Charter Research Standard Operating Procedures (SOPs).
Understand thoroughly all assigned studies through reading protocols, attending start-up meetings, and related training, and coordinating with Principal Investigator.
Complete and maintain all training mandated by sponsors, Contract Research Organizations (CROs), study vendors, and Charter Research.
Adhere strictly to the study protocols and their associated data entry standards, utilizing the Electronic Case Report Form (eCRF) guidelines and data capture snapshots provided by the sponsor, CRO, and EDC vendor.
Perform compliance reviews of source documentation, confirming documentation of informed consent processes, study eligibility, and data capture in compliance with ALCOA-C standards.
Maintain metrics related to volume, timeliness, and accuracy of data collection and entry to be used in analyzing efficiencies and identifying opportunities for improvement.
Communicate issues with clinical study data to the appropriate Clinical Research Coordinator, Clinical Team Lead, Physician Investigator, Finance Associate and Clinic Manager.
Work closely with each assigned study's Clinical Research Associate (CRA) to facilitate the sponsor and CRO data monitoring and maintenance processes.
Investigate and respond to all data queries in a timely manner in collaboration with members of the clinical research team.
Prepare for and/or participate in quality compliance and quality assurance audits conducted by study sponsors, federal agencies, or other review groups.
KNOWLEDGE, SKILLS, AND ABILITIES
Excellent interpersonal and customer service skills.
Knowledge of medical terminology.
Exceptional organizational skills and attention to detail.
Strong verbal and written communication skills.
Ability to work well both independently and as part of a team.
Ability to handle multiple tasks simultaneously and adapt to changes in workload.
Must possess a high degree of integrity and the ability to maintain confidentiality with HIPAA guidelines, patient matters, and other sensitive information.
Experienced in the use of computers, including both Microsoft Office and data entry systems.
QUALIFICATIONS
Education & Experience
Bachelor's degree preferred - preferably in psychology, biology, health sciences, or a related field.
1-3 years of related experience preferred.
Language
Fully bilingual English and Spanish is required.
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.