Job Details
Company Overview:
Our client is a prominent clinical research organization committed to advancing medical knowledge and enhancing patient care. We are currently seeking a motivated Clinical Research Assistant to join their team in San Antonio, TX.
Job Description:
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).
- Prior experience in clinical research or healthcare administration preferred.
- Strong attention to detail and organizational skills.
- Excellent written and verbal communication abilities.
- Proficiency in Microsoft Office suite.
- Familiarity with regulatory requirements governing clinical research (e.g., FDA regulations, ICH-GCP guidelines) is desirable.