Job Description

Highlights

• Play a key role in helping patients get involved in clinical trials
• up to $21 - $30 an hour + full benefits
• Growth opportunities to CRC, Sr. CRC, and more!
• Great stepping stone into research, or a way to get more experience!

As an 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.

Job Tags

Similar Jobs