Data Coordinator II supporting clinical trials research at Winship Cancer Institute. Facilitating data management and ensuring accuracy of clinical trial databases with compliance to protocol guidelines.
About the role
- Clinical Research Specialist overseeing regulatory activities and supporting clinical research studies in a hybrid role at a comprehensive rheumatology clinic.
Responsibilities
- Correspond with research sponsors, CROs, and other research organizations regarding study initiation and ongoing study activities
- Prepare, complete, and submit required study documentation and regulatory materials
- Assist in preparing reports for analysis and submission to study sponsors
- Organize and manage clinical trial agreements, budgets, and confidentiality disclosures
- Respond to study-related correspondence, including protocol inquiries and information requests
- Support the successful conduct of assigned clinical studies in accordance with regulatory requirements, guidelines, and internal policies
- Assist with identification, resolution, and follow-up of site-related issues
- Assist in the preparation of study materials and provide training support for electronic systems or devices
- Contribute to the review, maintenance, and development of standard operating procedures (SOPs)
- Provide additional administrative or research support as requested by clinical management
Requirements
- Minimum of 3 years of experience in a clinical setting
- Minimum of 2 years of experience in a clinical research role
- Associate’s or Bachelor’s degree in business, healthcare, or a related field
- Working knowledge of patient care, medical terminology, and pharmacology (medical background preferred)
- Strong interpersonal, organizational, and customer service skills
- Proficiency with computers and familiarity with electronic medical records (EMR/EHR systems)
- Ability to work independently and effectively manage multiple priorities
- Strong attention to detail and accuracy
- Excellent verbal and written communication skills.
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