Clinical Research Regulatory Specialist

🔥 0 minutes ago

🐊 Florida – Remote

🐊 Florida – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 10%

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Alcanza Clinical Research

WebsiteLinkedInAll Job Openings

201 - 500 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Alcanza Clinical Research is a company dedicated to advancing clinical research through inclusive and impactful methodologies. They facilitate the participation of diverse populations in clinical trials by lowering barriers and ensuring high-quality research practices. Alcanza collaborates with medical providers and community organizations to provide patients with access to cutting-edge treatment options and health education across various therapeutic areas, without requiring insurance. Participants can benefit by receiving healthcare access, emerging treatments, and compensation for their time. The company is committed to patient safety and data integrity, providing opportunities for individuals to contribute to healthcare advancements across many locations in the United States.

📋 Description

• Maintain regulatory documents and binders in an organized, systematic manner for monitoring and auditing throughout research studies. • Follow organizational SOPs and provide guidance on staff comprehension and compliance. • Facilitate communication with the IRB and/or sponsors. • Assist with and coordinate development of clinical trial support documents and regulatory filings. • Distribute IND safety reports to investigators and the research team for review. • Assemble, reproduce, and archive technical documents in hard-copy and electronic formats. • Collaborate with the research team to facilitate protocol operations. • Identify problems and issues, take corrective action, and escalate appropriately. • Track sponsor and IRB approvals and renewals. • Report on clinical trial status. • Generate and review regulatory data reports using appropriate systems. • Ensure assigned tasks comply with federal regulations and ICH/GCP. • Achieve documentation quality standards within project and company timelines. • Assist in training programs as requested. • Perform other assigned duties.

🎯 Requirements

• A Bachelor’s degree and a minimum of 2 years experience in clinical research, OR an equivalent combination of education and experience, is required. • 1+ years of regulatory experience is preferred. • Knowledge of GCP/ICH guidelines is required. • Proficiency with Microsoft applications, email, electronic health records, web applications, and typing at 40+ wpm. • Strong organizational skills, attention to detail, and basic math proficiency. • Well-developed written and verbal communication skills. • Well-developed interpersonal and listening skills. • Ability to work independently and collaboratively with co-workers, subjects, managers, and external customers. • Ability to effectively handle multiple tasks and adapt to changes in workloads and priorities. • Professionalism, respect for others, self-motivation, and a strong work ethic. • High degree of integrity and dependability. • Ability to work under minimal supervision, identify problems, and assist in implementing solutions. • Ability to handle highly sensitive information confidentially and professionally, in compliance with HIPAA guidelines.

🏖️ Benefits

• Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire. • Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.