Clinical Research Associate

2 settimane fa

Milano, Italia Optimapharm d.o.o. A tempo pieno

**Who we are?**:
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?**:

- 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.

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