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Clinical Research Associate
hace 4 meses
Job Description
The role required is accountable for performance and compliance for assigned protocols and sites in a specific country.
Under the supervision of the CRA manager, the individual ensures compliance of study conduct with ICH/GCP and country regulations, Company policies and procedures, quality standards, and adverse event reporting requirements both internally and externally.
Serves as the main contact at sites and site manager during all stages of a clinical research study, taking on overall responsibility for allocated sites.
Actively seeks to expand the territory for clinical research by discovering and nurturing new sites.
Participates in internal meetings and workstreams as a Subject Matter Expert (SME) for monitoring processes and systems.
- Responsibilities include, but are not limited to:
- Builds strong site relationships and ensures their continuity across all trial phases.
- Manages clinical study site activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan, and associated documents.
- Develops a deep understanding of the study protocol and related procedures.
- Coordinates tasks in collaboration with other sponsor roles to achieve Site Ready status.
- Provides input on site selection and validation activities.
- Conducts remote and on-site monitoring activities to ensure data accuracy and subjects' well-being and rights protection.
- Performs various site visits and maintains regulatory documentation for study start-up, maintenance, and close-out.
- Communicates with Investigators and site staff on protocol-related issues, recruitment, retention, deviations, and site performance.
- Identifies and resolves site performance, quality, or compliance issues and escalates when necessary.
- Collaborates with internal and external stakeholders to support assigned sites.
- Manages information and documentation in various systems.
- Contributes to team knowledge by sharing best practices and acting as a mentor.
- Supports audit/inspection activities.
- Contributes to identifying new potential sites as per the country strategy.
Able to travel nationally and internationally around 65%-75% of the working time.
- CORE Competency Expectations:
- Proficient in Local Languages and English with excellent communication skills.
- Good understanding of clinical research, GCP/ICH guidelines, and local clinical research regulations.
- Familiar with Global, Country/Regional Clinical Research Guidelines.
- Experienced in Site Management and patient recruitment.
- Skilled in monitoring and data analysis.
- Capable of managing complex issues and implementing solutions.
- Behavioural Competency Expectations:
- Demonstrates effective time management, organizational, and problem-solving skills.
- Able to work independently across multiple protocols and therapy areas.
- Displays a high sense of accountability and handles tasks in a changing environment.
- Works well in a multicultural environment and maintains professional relationships.
- Commits to Customer focus and quality work.
- Possesses a positive and growth mindset.
- Demonstrates a professional demeanor consistent with organizational practices.
- Experience Requirements:
Required: Minimum 2 years of direct site management experience in the bio/pharma/CRO industry.
- Educational Requirements:
Preferred: B.A./B.S. with a strong emphasis in science and/or biology.
Please note that this job posting is valid until 11:59:59 PM on the day BEFORE the listed end date. Make sure to apply before that deadline.
