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Clinical Research Associate
hace 3 semanas
The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, Company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
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.
- 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.
- 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.
Extent of Travel
Ability to travel domestically and internationally approximately 65%-75% of working time. Expected travelling ~2-3 days/week.
**CORE Competency Expectations**:
- Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
- 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 Clinical Research Guidelines and ability to work within these guidelines. -Hands on knowledge of Good Documentation Practices
- Proven Skills in Site Management including management of site performance and patient recruitment
- Demonstrated high level of monitoring skill with independent professional judgment
- Effective time management, organizational and interpersonal skills, conflict management, problem solving skills
- Able to work highly independently across multiple protocols, sites and therapy areas
.High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment. -Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships
.Demonstrates commitment to Customer focus
.Works with high quality and compliance mind-set
**Experience Requirements**:
Required:
- Min. 2 years of direct site management (monitoring) experience in a bio/pharma/CRO.
**Educational Requirements**:
Preferred: -B.A./B.S. with strong emphasis in science and/or biology
**Search Firm Representatives Please Read Carefully**
**Employee Status**:
Regular
**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
Hybrid
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Job Posting End Date**:
06/28/2024
**Job Posting End Date**:06/28/2024
**Requisition ID**:R299352
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