Clinical Trials Site Coordinator
2 semanas atrás
Milestone One is seeking a highly skilled Clinical Trials Site Coordinator to support our clinical study sites in various activities related to clinical trials. The successful candidate will be responsible for ensuring the smooth execution of clinical trials, maintaining effective communication with sponsors and CROs, and ensuring compliance with ICH-GCP and protocol requirements.
Key Responsibilities:- Act as the primary point of contact between the sponsor or CRO and the site.
- Ensure timely responses to feasibility questions.
- Assist in scheduling and preparation for monitoring visits.
- Be present and available to respond to monitors during monitoring visits.
- Track patient enrollment and support the site and CRO/Sponsor team in meeting project timelines and enrollment goals.
- Maintain study-specific and general tracking of documents at the site level.
- Accurately and timely enter data into study-specific EDC systems and resolve data clarification queries.
- Timely report and follow up on Reportable Adverse Events and Protocol Deviations.
- Properly handle, account for, and reconcile investigational products and clinical supplies.
- Collect, handle, and maintain site-specific regulatory documents as needed.
- Facilitate and support contract and budget negotiations at the site level.
- Support Investigator and Site payments and processes as needed.
- Schedule and/or perform study procedures as per study requirements and delegation of responsibilities.
- Prepare for and participate in onsite study audits or regulatory agency inspections.
- A university degree in Life Science, preferably in pharmacy, nursing, or lab analytics.
- Minimum of 2 years of on-the-job experience in a clinical trial environment, with relevant experience in clinical trials, clinical terminology, and medical research.
- Ability to work in a fast-paced environment with short timelines and multiple tasks.
- Ability to effectively communicate in stressful situations and demonstrate problem-solving skills.
- Valid US Driver's License with the ability to travel as needed.
- Flexibility in working hours may be required depending on the schedule of study procedures and/or patient visits.
Milestone One is a developing company with a true focus on its people. We offer a dynamic and supportive work environment where you can grow and develop your skills and knowledge. If you are looking for a challenging and rewarding role, we encourage you to apply.
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