Clinical Research Director
3 weeks ago
We are seeking an experienced Clinical Research Director to join our team at Tilda Research Inc. as a Principal Investigator (PI) for our Birmingham, AL site.
Key Responsibilities- Protocol Execution: Ensure the successful execution of research protocols, patient safety, and compliance with regulatory requirements.
- Partnership Opportunity: Collaborate with Tilda Research to conduct clinical research, leveraging our facilities, staff, systems, and business development expertise.
- Medical Direction: Provide overall medical direction and review of protocols in conformance with the investigational plan and good clinical practice.
- Feasibility Assessments: Conduct medical and scientific feasibility assessments for all new sponsor inquiries.
- Participant Safety: Ensure the safety and well-being of all participants in the study at the trial site.
- Data Integrity: Ensure data collected at the study site is credible and accurate.
- Participant Rights: Ensure the rights, integrity, and confidentiality of all participants in the trial at the site are protected.
- Monitoring and Auditing: Participate in monitoring visits and sponsor meetings, allowing monitoring and auditing by sponsors and inspection by regulatory agencies.
- Study Procedures: Perform physical assessments and study procedures, review participants' medical history, administer Investigational Product, and review and adhere to the study protocol.
- Regulatory Compliance: Ensure accuracy, completeness, legibility, and timeliness of data reported on the CRF (case report form) and be consistent with source documents.
- Reporting: Immediately report Serious Adverse Events (SAEs) or any abnormalities affecting participants' safety to sponsors and the IRB as per specific reporting guidelines.
- Documentation: Maintain proper documentation, ensuring that the study, consent, and other documents provided to the subjects are approved by the IRB and comply with GCP and other regulatory requirements.
- Medical Degree: Medical degree (MD or DO) with board certification in Internal Medicine or Family Medicine.
- Active Medical License: Active medical license in California.
- Clinical Research Experience: Clinical research experience is required with a minimum of 10 completed studies.
- Business Development: We liaise with sponsors to secure studies for you.
- Facilities and Equipment: Modern infrastructure ready for any clinical trial.
- Dedicated Staff: Our team includes Clinical Research Coordinators (CRCs), Research Associates (RAs), Nurses, Pharmacists, and more, ready to support you.
- Advanced Systems: Tilda has a proprietary technology system for executing trials end-to-end that prioritizes automation, increases flexibility, and minimizes administrative work for investigators.
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Clinical Research Director
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Clinical Research Director
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