Senior Clinical Research Associate

Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment. At Allucent, our mission is to help bring new therapies to light.When you work at Allucent, that means rolling up your sleeves and applying your scientific knowledge, clinical expertise, and experience to partnerships with our clients in small and mid-sized biotech companies.

These customers have new therapeutic ideas but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in patients’ lives.

Location: Italy

Experience: 3+ years as CRA

Language: Fluent in English & Italian

Therapeutic Areas: Oncology preferred

The Sr. Clinical Research Associate (Sr. CRA) will be responsible for the following tasks:

Site Management

• Prepare/review SIV slides and perform Site Initiation Visits to train and instruct site staff on the study requirements
• Assist in site activation
• Perform Monitoring visits to:

• verify that source data and study database are accurate, complete and maintained properly
• verify subject eligibility
• verify protocol compliance, including safety reporting and drug handling
• verify all study files are maintained and up to date
• support site staff in preparation for study specific site audits and inspections

• Perform Close-out visits
• Perform Pre-study visits, if delegated by SSU
• Perform centralized and risk based monitoring activities
• Act as the main line of communication between the study PM/LCRA and the site staff
• Maintain study related trackers
• Prepare site visit reports
• Liaise with site staff to achieve patient recruitment targets
• Contribute to the development of study specific documents
• Support the study start-up team in preparation of submission packages and collection of site documents, if delegated by SSU
• Review of site visit reports
• Assist the study PM/LCRA in coordinating and supporting CRA activities

Management, Learning & Development

• Actively support site management staff learning & development within the company
• Perform Co-Monitoring visits
• Supervise and guide CRA trainees, CRA I and/or CRA II

Quality Management

• Draft and contribute as Subject Matter Expert (SME) in the field of Site Management activities to the evaluation/improvement of processes and procedures within the Quality Management System
• Assure good communication and relationships with (future) clients
• Contribute and take part in client evaluations, visits and bid defenses
• Contribute to internal and external audits

Requirements

Qualifications:

• Life science, healthcare, medicine and/or related degree
• Minimum 3 year of CRA experience
• Minimum 3 years of experience in drug development and/or clinical research
• Thorough knowledge of ICH-GCP, privacy legislation (GDPR and/or HIPPA), regulations (CTR/CTD and/or CFR), and applicable local regulatory requirements
• Good understanding of site management and monitoring
• The ability to perform site visits in an effective way and having performed all different types of site visits (Initiation visit, Monitoring visit and Close-out visits)

Skills:

• Strong written and verbal communication skills including good command of English AND Italian languages
• Representative, outgoing and client focused
• Ability to work in a fast-paced challenging environment of a growing company
• Administrative excellence with attention to detail and accuracy
• Proficiency with various computer applications such as Word, Excel, and PowerPoint required
• Strong organizational skills

Benefits

• Comprehensive benefits package
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• Opp