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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