Clinical Trials Start Up Specialist

Summary:

The Clinical Trials Start Up Specialist plays a crucial role in Wesley Research Institute by ensuring the efficient initiation of clinical trials. This position involves coordinating with various stakeholders to facilitate the start-up process, ensuring compliance with regulatory requirements, and contributing to the overall success of clinical research projects. The specialist will be instrumental in streamlining processes and enhancing the quality of trial operations.

Responsibilities:

• Coordinate the start-up activities for clinical trials, including site selection and initiation.
• Prepare and submit regulatory documents to ensure compliance with local and international guidelines.
• Collaborate with cross-functional teams to facilitate the timely execution of trial protocols.
• Maintain accurate and up-to-date trial documentation and records.
• Assist in the training of site staff on trial protocols and procedures.
• Monitor and report on the progress of start-up activities, identifying and resolving any issues that arise.
• Liaise with regulatory authorities and ethics committees as required.

Experience:

• Minimum of 1 year experience in clinical trial start-up or related roles.
• Detailed knowledge of relevant regulations, guidelines, and ethical standards, including Good Clinical Practice (GCP), Good Documentation Practice (GDP), Therapeutic Goods Administration (TGA) requirements, and Human Research Ethics Committee (HREC) processes.
• Proven ability to manage clinical trial start-up activities, including feasibility assessments, ethics submissions, and budget/contract negotiations.
• Excellent communication and interpersonal skills, with a strong ability to manage relationships across a variety of stakeholders, including clinicians, researchers, sponsors, and regulatory bodies.