Clinical Research Associate (M/F/D) - Italy Milano

Clinical Research Associate (M/F/D) - Italy
Milano
Lombardia, Milano

Who we are?

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Optimapharm is a **leading, mid-sized, full-service CRO working across Europe and North America** to deliver new therapies to improve and save patients' lives.

Optimapharm's key priorities are our people and consistently exceeding our client's expectations.

With **27 strategically located offices**, Optimapharm operates in 40+ countries, giving unrivaled access to Patients and Investigators in all countries in Europe and North America.

In-depth expertise and long-standing experience, combined with a flexible and collaborative approach, allow optimization of design and planning; through its strong track record of delivery excellence and committed and stable project teams, Optimapharm has secured a high level of repeat business over the years.

We are looking for a **CRA III/Senior** CRA **to join our **Clinical Operations team in Italy **and support us in making a tangible difference to project sponsors and benefiting patients and their families all around the world.

**What do we offer?

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- Working in a successful company that's growing and changing every day

- Working with a highly experienced team of the clinical research professionals

- International projects and professional growth

- Performance bonus

- Training opportunities

- Flexible work hours

- Home-based position

- Summer work schedule

**Who are we looking for?

**:

**Qualifications and** Experience**:

- University degree, **preferably in medical or life sciences**.

Individuals with a university degree in biotechnical, technical, bio-medicinal, social, or humanistic sciences must have a nursing education or other relevant healthcare college degree.

- At least **3 years** of independent clinical trial monitoring experience**:

- Experience in **oncology** and start-up activities **is an advantage

- High level of knowledge of ICH GCP Guidelines, knowledge of regulatory requirements, and a strong interest in clinical research

- ** Fluent in local language and English**; both, written and verbal

- 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 with mínimal supervision, pro-active

- Affinity to work effectively and efficiently in a matrix environment

- Excellent numerical skills and reasoning ability

- A current, valid driver's license would be advantageous

**Your **responsibilities**:

- Perform routine site visits with mínimal guidance, 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

- With mínimal supervision, 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.