Clinical Research Monitor
1 settimana fa
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 optimal access to patients and investigators worldwide. Established nearly 20 years ago, we leverage our experience, stable project teams and a collaborative, flexible approach to secure a high level of repeat business, gain the trust of new customers and continue to grow.
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 least 2‐3 years of independent clinical trial monitoring in a CRO/pharma
At least 1.5 years of experience in oncology (solid tumors); gastroenterology experience would be considered 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 re‐training opportunities for site personnel
Preparation of corrective and preventive (CAPA) plans for issues identified during monitoring activities and pro‐active follow‐up 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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