Clinical Research Data Coordinator I

Day (United States of America)

2415 N Orange Ave

Orlando

Florida

32804

Obtains essential protocol-required information as outlined by the approved study protocol and within contractual obligations. Assists with the identification, collection, and reporting of protocol deviations, adverse events, and serious adverse events in accordance with ICH, CFR, GCP, and protocol-specific guidelines. Ensures PI signatures on eCRFs and ensures all study investigators complete applicable EDC training. Contributes to tasks related to site monitor visits and/or audits conducted by the institution, industry sponsors, the FDA, and other authorities. Corresponds with personnel at external institutions to ensure timely and specified data acquisition. Onboards and precepts new team members Manages accurate and timely retrieval and electronic data entry submission of protocol-driven data points to relevant research sponsors/organizations. Abstracts and records essential physical and test data from internal and external sources. Maintains a tracking system of study participants at relevant time points. Conducts follow-up visits and data searches to maintain smooth operational flow. Prepares and provides participant status reports to leadership as requested. Completes and maintains sponsor training and certifications on protocol-specific Electronic Data Capture (EDC) systems and portals. Contributes to ongoing research activities by meeting with study sponsor monitors, CRCs, and Principal Investigators to review study data and resolve data queries. Other duties as assigned.Knowledge, Skills, and Abilities:
• Strong interpersonal skills to interact and maintain good relationships with a broad spectrum of healthcare disciplines and the public. [Required]
• Excellent organizational, multi-tasking, and problem-solving skills with extreme attention to detail. [Required]
• Excellent understanding of project management concepts in order to ensure protocol compliance. [Required]
• Ability to work independently as well as with a team at a steady pace, perform multiple tasks with competing priorities, meeting and managing frequent deadlines, and accommodate changing priorities. [Required]
• Ability to apply analytical approach to problem solving, obtain and analyze facts, and apply sound judgement. [Required]
• Knowledge of research terminology, medical terminology, and HIPAA data protections. [Required]
• Proficient in Microsoft Office applications (i.e., Word, Outlook, Teams, Excel, etc.) and Internet knowledge and skills. [Required]
• Clinical Trials Management System (or equivalent) and/or Electronic Data Capture (EDC) exposure. [Preferred]
• Advanced computer skills. [Preferred]
• Knowledge of clinical research and research regulatory environment. [Preferred]
• Proficient in the ability to navigate through various electronic data transfer portals and systems. [Preferred]

Education:
• Associate [Required]
• Bachelor's [Preferred]

Field of Study:
• in healthcare related field, data processing or related field
• in health science, or related field, and one (1) year of administrative/professional experience with data related responsibilities (e.g. research, statistics, registry) or clinical research experience,
• Graduate of an accredited allied health certificate program and two (2) years of administrative/professional experience with data related responsibilities (e.g. research, statistics, registry) or clinical research experience,
• Advanced training/experience in data related items, inclusive of databases and various EDC systems.

Work Experience:
• 2+ years of direct clinical research data entry experience or three (3) years of equivalent administrative/professional experience working with data or medical information to include duties such as data collection, management and verification [Required]
• 2+ years of direct clinical research experience [Preferred]
• Healthcare experience (medical assistant, allied health care professional, etc.) within an office or hospital setting. [Preferred]

Additional Information:
• N/A

Licenses and Certifications:
• N/A

Physical Requirements: (Please click the link below to view work requirements)
Physical Requirements - https://tinyurl.com/23km2677

$44,033.60 - $81,910.40