Highlights

• Play a key role in helping patients get involved in clinical trials
• Located in Little Havana
• up to $18 - $22 an hour full benefits
• Bilingual Spanish Required*****
• Monday - Friday; no weekends!
• Growth opportunities to CRC, Sr. CRC, and more!
• Great stepping stone into research, or a way to get more experience!

As an entry-level Clinical Research Assistant, you will be integral to the success of our research endeavors, providing essential support throughout all phases of clinical trials. Key responsibilities include:

• Assist in Start-up and Implementation Activities: Collaborate with the research team to facilitate the initiation of new studies, including protocol development and regulatory submissions.
• Completion and Submission of Clinical Trials Amendments: Ensure timely completion and accurate submission of all amendments to the Institutional Review Board (IRB), adhering to regulatory guidelines and protocols.
• Editing Informed Consent Documents: Review and edit informed consent documents to ensure clarity, accuracy, and compliance with regulatory standards.
• Correspondence with Stakeholders: Serve as a primary point of contact for communication with the IRB, investigators, and sponsors throughout the clinical trial process, maintaining open lines of communication and addressing inquiries promptly.
• Preparation of Annual Progress Reports: Compile and prepare comprehensive progress reports for IRB renewal of ongoing studies, summarizing key findings and milestones achieved.
• Collection and Submission of Regulatory Documents: Facilitate the collection, completion, and submission of regulatory documents to various regulatory entities, ensuring compliance with regulatory requirements.
• Maintenance of Regulatory Binders: Establish and maintain regulatory binders and other relevant files, organizing documentation meticulously during the review, approval, and activation process for clinical trials.
• Coordination of Safety Reports: Coordinate the review and processing of safety reports to the IRB, ensuring prompt reporting and appropriate follow-up actions as required.

Qualifications:

• Bachelor's degree in a relevant field (e.g., life sciences, healthcare administration, or related discipline) preferred.
• Prior experience in clinical research or healthcare administration is preferred.
• Experience with Phlebotomy, EKG, taking Vitals, etc. REQUIRED
• Strong attention to detail and organizational skills.
• Excellent written and verbal communication abilities.
• Familiarity with regulatory requirements governing clinical research (e.g., FDA regulations, ICH-GCP guidelines) is desirable.