Clinical Research Data Coordinator I

Team Member Services; Orlando (FL); On-site; USD 52,000 - 76,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

Paid time off from day one

403-B retirement plan

Parental leave (4 weeks)

Career development

Mental health resources

Well-being resources

Pet benefits

Job summary

AdventHealth in Orlando seeks a dedicated Clinical Data Entry Specialist to manage protocol-driven data and support site monitoring. You will ensure timely data capture and maintain essential study records within EDC systems.

The role requires 2+ years of clinical research data entry, strong organizational skills, and knowledge of HIPAA. Day shift, full-time, on-site at AdventHealth Orlando.

Qualifications

• 2+ years of direct clinical research data entry experience.
• Knowledge of clinical research terminology and HIPAA data protections.
• Experience with EDC systems or CTMS is preferred.

Responsibilities

• Obtain and input protocol-driven data points per study protocol.
• Assist with site monitoring visits and audits.
• Prepare participant status reports for leadership.
• Maintain documentation and data queries with study monitors.

Skills

Interpersonal skills

Organizational skills

Project management

Independent/work with team

Analytical/problem solving

HIPAA/data protection knowledge

MS Office proficiency

Attention to detail

Education

Associate

Bachelor's

Tools

EDC systems

Job description

Our promise to you:

Joining AdventHealth is about being part of something bigger. It's about belonging to a community that believes in the wholeness of each person, and serves to uplift others in body, mind and spirit. AdventHealth is a place where you can thrive professionally, and grow spiritually, by Extending the Healing Ministry of Christ. Where you will be valued for who you are and the unique experiences you bring to our purpose-minded team. All while understanding that together we are even better.

All the benefits and perks you need for you and your family:

• Benefits from Day One: Medical, Dental, Vision Insurance, Life Insurance, Disability Insurance
• Paid Time Off from Day One
• 403-B Retirement Plan
• 4 Weeks 100% Paid Parental Leave
• Career Development
• Whole Person Well-being Resources
• Mental Health Resources and Support
• Pet Benefits

Schedule:

• Full time
• Shift: Day (United States of America)

Address:

2415 N Orange Ave
City: Orlando
State: Florida
Postal Code: 32804

Job Description:

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]