Clinical Research Director

3 weeks ago


Homewood, Alabama, United States Tilda Research Inc. Full time
About the Role

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.
Responsibilities
  • 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.
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.
What We Offer
  • 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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