Associate Clinical Research Associate Lazio

Associate Clinical Research Associate
Roma
Lazio, Lazio

Secondary** Language(s) Job Description**:

We are looking for an **Ass. Clinical Research Associate** to join our Clinical Research Monitor Team.

With support of SrCRA/CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites.

**Responsibilities include, but are not limited to**:

- Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.

- Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents

- Gains an in-depth understanding of the study protocol and related procedures

- Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready

- Participates & provides inputs on site selection and validation activities

- Performs remote and on-site monitoring & oversight activities using various tools to ensure: Data generated at site are complete, accurate and unbiased; Subjects' right, safety and well-being are protected

- Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner

- Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out

- Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance

- Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines

- Supports audit/inspection activities as needed

- Performs co-monitoring where appropriate.

**Experience Requirements**:

- Min. 2 years of clinical research experience. Related CR experience may include Clinical Trial Assistant, Study Coordinator, Regulatory CTC or similar.

**Educational Requirements**:

- B. A. /B. S. with strong emphasis in science and/or biology

**CORE Competency Expectations**:

- Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand technical information. Developing ability to present technical information with support.

- Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.

- Good understanding of Global, Country/Regional CRA Guidelines and ability to work within these guidelines.

- Hands on knowledge of Good Documentation Practices

- Developing skills in Site Management including management of site performance and patient recruitment

- Developing level of monitoring skill and independent professional judgment.

- Works with high quality and compliance mindset.

- Capable of managing complex issues, solution-oriented approach.

- Ability to perform root cause analysis and implement preventative and corrective action

**Search Firm Representatives Please Read Carefully

**Employee Status**:

Regular

**Relocation**:

**VISA Sponsorship**:

**Travel Requirements**:

**Flexible Work Arrangements**:

Remote

**Shift**:

**Valid Driving License**:

**Hazardous Material(s)**:

**Job Posting End Date**:

10/4/2024

**Job Posting End Date**:10/04/2024

**Requisition ID**:R314759