Clinical Research Associate II/III - Italy

Optimapharm; Remoto; EUR 30.000 - 50.000; Tempo pieno

Descrizione del lavoro

A leading clinical research organization in Milan is seeking a CRA II - III to oversee clinical trials. This position requires a university degree in life sciences, at least 2-3 years of clinical trial monitoring experience, and a strong knowledge of ICH GCP Guidelines. The role offers flexible work hours and home-based options, along with competitive compensation. If you're ready to advance in the clinical research field, we want to hear from you!

Servizi

Performance bonus

Flexible work hours

Home-based position

Meal vouchers

Shopping discounts

Training and development programs

Competenze

• Minimum 2-3 years of independent clinical trial monitoring in a CRO/pharma.
• Experience in oncology required; gastroenterology experience is a plus.
• Must be a certified CRA as per Italian regulations.
• Strong knowledge of ICH GCP Guidelines and regulatory requirements.

Mansioni

• Perform routine site visits, including pre-study and closeout visits.
• Manage assigned sites to ensure compliance and adequate enrolment.
• Negotiate study budgets with investigators and assist in site contracts.
• Prepare documents for ethics committee submissions.

Conoscenze

Communication Skills

Interpersonal Skills

Negotiation Skills

Computer Proficiency

Independent Work

Formazione

University degree in medical or life sciences

Descrizione del lavoro

📌 Location: located in North Italy; Milan

🎯Who we are?

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.

🎁 What do we offer?

• Working in a successful company that’s growing and developing every day
• Working with a highly experienced team of clinical research professionals
• Performance bonus
• Referral bonus
• Flexible work hours
• Home-based position
• Working from home allowance
• Meal vouchers
• Shopping discounts
• Employee engagement programs
• Well-being initiatives
• Training and development program

🔎 Who are we looking for?

💼 Qualifications and Experience

• 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
• Ability to read, analyze, and interpret common scientific and technical journals
• Excellent verbal and written communication skills
• Very good interpersonal and negotiation skills
• Ability to work independently, pro-active
• Affinity to work effectively and efficiently in a matrix environment
• A current, valid driver’s license

📑 Your responsibilities

• Perform routine site visits independently, including pre-study, initiation, interim monitoring and closeout visits
• Manage assigned sites by regular contact with site personnel to ensure site compliance, adequate enrolment and understanding of study requirements
• Independently perform CRF review; 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
• Preparation of documents required for EC submissions and notifications, translation of study-related documents (where applicable), and other tasks as instructed by the supervisor
• 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

By joining our fast-growing and prosperous team, you will have an excellent opportunity for further personal growth and career development.

If you would be interested in joining the Optimapharm team, please send your CV and note that only shortlisted candidates who meet the requirements will be contacted for the further selection process.

Compensation is competitive and final offers will reflect each candidate’s experience, skills, and qualifications.

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. Optimapharm follows a direct sourcing strategy and collaborates exclusively with selected recruitment partners when external support is required.