Sr. Clinical Research Associate

hace 3 días

Munro, Argentina MSD A tiempo completo

Are you an experienced Clinical Research Associate looking for a new opportunity to excel in your career? Join our dynamic team and make a difference in the field of clinical research. We are seeking a highly motivated and detail-oriented individual to oversee and manage clinical research protocols and sites in Argentina. As a Clinical Research Associate, you will play a crucial role in ensuring compliance with regulations, company policies, and quality standards.

**Responsibilities**:

- Develop strong site relationships and ensure continuity throughout all phases of the trial.
- Perform clinical study site management activities in compliance with ICH-GCP, Sponsor SOPs, local laws & regulations, and protocol requirements.
- Gain in-depth understanding of study protocols and related procedures.
- Coordinate and manage tasks in collaboration with other sponsor roles to achieve site readiness.
- Collect, review, and monitor regulatory documentation for study start-up, maintenance, and close-out.
- Communicate with investigators and site staff on protocol conduct, recruitment, retention, and regulatory compliance.
- Identify and resolve site performance, quality, or compliance issues in collaboration with relevant stakeholders.
- Work collaboratively with internal teams and external partners in support of assigned sites.
- Manage and maintain information and documentation in various systems.
- Support audit and inspection activities as required.
- Contribute to the identification and development of new potential sites.

**Requirements**:

- Minimum 4 years of direct site management (monitoring) experience in bio/pharma/CRO.
- Fluent in local languages and English (verbal and written) with excellent communication skills.
- Excellent understanding of clinical research, GCP/ICH guidelines, and country-specific regulations.
- Demonstrated ability to mentor and lead.
- Ability to analyze data/metrics and take appropriate action.
- Experience with site motivational visits to boost enrollment.
- Capable of managing complex issues and implementing corrective action.
- B.A./B.S. with strong emphasis in science and/or biology preferred.

**Why Join Our Team**:

- Opportunity to work in a dynamic and growing company at the forefront of clinical research.
- Collaborative and supportive work environment.
- Growth and development opportunities.
- Competitive salary and benefits package.

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
No relocation

**VISA Sponsorship**:
No

**Travel Requirements**:
10%

**Flexible Work Arrangements**:
Not Applicable

**Shift**:
Not Indicated

**Valid Driving License**:
No

**Hazardous Material(s)**:
no

**Job Posting End Date**:
11/4/2024

**Requisition ID**:R307152

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