Clinical Research Associate
hace 1 día
Job Description:
Clinical Research Associate - Study Execution Specialist
We are seeking a highly skilled and experienced Clinical Research Associate (CRA) to join our team as a Study Execution Specialist. In this role, you will be responsible for coordinating and overseeing the execution of studies and clinical trials according to the study protocol, ICH-GCP, applicable regulations, guidelines, and sponsor requirements.
Key Responsibilities:
- Identify investigator sites and participate in the feasibility process for new studies.
- Perform site monitoring visits (selection, initiation, monitoring, and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., ICH GCP.
- Interact with the Trial Start-up team and support collecting the documents or information necessary for the ethical and administrative submission.
- Work closely with the sites to ensure that the planned recruitment targets are in line with the study plan/projections and motivate Investigators to achieve the targets.
- Check the correct submission and completion of informed consent forms.
Requirements:
- Enthusiastic, knowledgeable, and proactive individual with a university degree in a scientific/life science field.
- At least 2 years of experience in managing and conducting clinical trials.
- In-depth knowledge of ICH GCP principles and the ability to carry out independently all the activities related to the monitoring of clinical trials.
- Good knowledge of Office Suite (Word, Excel, PowerPoint) and organizational and problem-solving skills.
- Excellent written and verbal communication skills including a good command of the English language.
- No restrictions to travel onsite.
About OPIS S.R.L.
Founded in 1998 in Italy, OPIS is a full-service science-driven biotech-focused CRO providing premium trial management for multi-country clinical trials, including state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of current projects.
Salary: €60,000 - €80,000 per annum, depending on experience.
This is a unique opportunity to join a dynamic and growing company in the biotech industry, with a competitive salary and excellent benefits package. If you are a motivated and experienced CRA looking for a new challenge, please submit your application.
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