Clinical Research Associate Contractor

6 meses atrás

Lisboa, Portugal Allucent Tempo inteiro

**CATO SMS and Pharm-Olam, LLC have merged to form Allucent**

**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.

We are currently recruiting for a **Portuguese-speaking Clinical Research Associate (CRA) - Contractor** to join our team in **Portugal**. The Clinical Research Associate (CRA) - Contractor coordinates and performs site management and monitoring activities within the Site Management department of Allucent’s Clinical Trial Operations. The SCRA monitors site performance and provides mentoring to CRA trainees/CRA I-II study team members. The CRA - Contractor acts as the main line of communication between the participating sites and the Lead CRA/PM.

**Location: Portugal (Portuguese-speaking)**

**Therapeutic Area: Oncology, Rare Disease and Pediatric**

**Availability: FTE = 0.5**

**Responsibilities**:
**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 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

**Account Management, Sales & Acquisition**
- Assure good communication and relationships with (future) clients
- Contribute and take part in client evaluations, visits and bid defenses

**Other**
- Contribute to other areas of business as required
- 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 **Portuguese and English** language
- 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
- Strong organizational skills

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