Clinical Research Monitor

12 ore fa

Milano, Italia Optimapharm A tempo pieno

Optimapharm is a globally operating, leading, mid-sized, full-service CRO aiming to deliver new therapies to improve and save patients' lives.
Optimapharm' s key priorities are the well-being of our people, consistent quality delivery to our clients and healthy, sustainable growth.
With 26 strategically located offices, Optimapharm operates in 40+ countries, providing most optimal access to Patients and Investigators globally. Established nearly 20 years ago, we leverage our experience, stable project teams and collaborative, and flexible approach to secure a high level of repeat business, gain the trust of new customers and secure continued growth of the company.
We're expanding our team in Italy and looking for a new CRA (CRA II - III, depending on experience). Whether you're building your expertise as a CRA I or ready to step into a higher CRA role, this is your chance to shape the future of clinical research - delivering excellence for our sponsors and meaningful impact for patients and families worldwide. This role sits within a defined CRA career path: CRA I → CRA II → CRA III→ Senior CRA.
Working with a highly experienced team of clinical research professionals
- Flexible work hours
- Working from home allowance
- Well-being initiatives
- Training and development program
University degree, preferably in medical or life sciences; nursing education or other relevant healthcare college degree
- At least2 - 3yearsof independent clinical trial monitoring in a CRO/pharma
- At least 1,5 year of experience in oncology (solid tumors); gastroenterology experience would be considered as a plus
- Mandatory: certified CRA in accordance with the Italian Ministerial Decree
- High level of knowledge of ICH GCP Guidelines, knowledge of regulatory requirements and a strong interest in clinical research
- Computer proficiency is mandatory
- Excellent verbal and written communication skills
- Perform routine site visits independently, including pre-study, initiation, interim monitoring and closeout visits
- query generation and resolution against established data review guidelines or data management systems as applicable
- Identifying and escalating potential risks and identifying retraining opportunities for site personnel
- Preparation of corrective and preventive (CAPA) plans for issues identified during monitoring activities and pro-active follow of each, individual CAPA until timely resolution
- Independently negotiate study budgets with potential investigators/institutions and assist with the execution of site contracts as applicable
- Administration of site payments in accordance with relevant project instructions
Disclaimer: Unsolicited CVs sent to Optimapharm (Talent Acquisition Team, Hiring Managers or any other OPT employee) by recruitment agencies will not be considered for this role.

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