Cra Ii- Scra, Italy

Proclinical; Roma; Remoto; EUR 35.000 - 50.000; Tempo pieno

Descrizione del lavoro

A leading company in the pharmaceutical sector is seeking a CRA II- SCRA in Italy. This permanent role offers remote work flexibility, requiring strong compliance knowledge and interpersonal skills. Responsibilities include evaluating site files, ensuring regulatory compliance, and effective communication with study staff. Ideal candidates will possess a relevant degree and be willing to travel up to 75% for business purposes.

Competenze

• Degree or equivalent in a relevant discipline.
• Knowledge of GCP, ICH regulations, and other relevant regulatory requirements.
• Willingness to travel up to 75% for business purposes.

Mansioni

• Evaluate the investigator site file (ISF) for accuracy and timeliness.
• Ensure compliance with all regulatory and protocol requirements.
• Communicate effectively with study site staff and collaborate with central monitoring associates.

Conoscenze

Interpersonal skills

Communication skills

Computer literacy

Adaptability to new technologies

Formazione

Degree or equivalent in a relevant discipline

Descrizione del lavoro

Proclinical is recruiting a CRA II- SCRA in Italy for a CRO. This role is permanent and offers the flexibility to work remotely from anywhere in Italy. The client is committed to accelerating customer success.

Responsibilities

1. Regularly evaluate the investigator site file (ISF) for accuracy and timeliness.
2. Discuss serious concerns with the project team to develop activity plans and escalate issues when necessary.
3. Ensure compliance with all regulatory and protocol requirements related to ICH-GCP and Good Pharmacoepidemiology Practice (GPP).
4. Conduct investigational product (IP) inventory, reconciliation, and evaluate storage and security.
5. Ensure proper labeling, importation, and release/return of investigational products, adhering to GCP, local guidelines, and organizational processes.
6. Communicate effectively with study site staff and collaborate with central monitoring associates.
7. Perform other duties as assigned.

Skills & Requirements

• Degree or equivalent in a relevant discipline, or a combination of training, education, and experience.
• Knowledge of GCP, ICH regulations, and other relevant regulatory requirements.
• Computer literacy and adaptability to new technologies.
• Strong interpersonal, presentation, and communication skills, both verbal and written.
• Willingness to travel up to 75% for business purposes.

Proclinical is a specialist employment agency providing opportunities within pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. Proclinical Staffing is an equal opportunity employer.