Clinical Research Associate I
About the role
Premier Research is seeking a Clinical Research Associate I to support the Clinical Monitoring, Site Management, and Study Support Unit (SSU) teams. This role plays a crucial part in transforming life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. Your contributions directly impact patient care and medical innovation.
Responsibilities
- Delivers quality, timely monitoring reports for sponsor approval according to the Clinical Monitoring Plan (CMP) timelines
- Ensures the validity, correctness, and completeness of clinical data reviewed and collected at assigned sites in accordance with ICH GCP/ISO14155, protocol, and client requirements
- Maintains data integrity and ensures subject safety during monitoring visits in compliance with local and regional laws and country-specific regulations
- Plans daily activities for monitoring studies and prioritizes tasks based on site needs
- Prepares for and conducts on-site and remote qualification, study initiation, interim monitoring, dosing observation, and close-out monitoring visits as directed by the Clinical Monitoring Plan (CMP)
- Collaborates with the Clinical Lead or equivalent to manage site visits and address trial issues during the monitoring phase
Requirements
Undergraduate degree or its international equivalent in clinical, science, or health-related fields from an accredited institution; a licensed health-care professional (registered nurse); or equivalent work experience is required. Patient-facing, study-coordinating experience is preferred. Knowledge of ICH-GCP/ISO14155, FDA guidance documents, EU directives, local/regional regulations, and drug/device development and clinical monitoring procedures is necessary. Familiarity with clinical/health systems and understanding of cultural and professional practices relevant to the country/region where site monitoring activities will occur is beneficial. Ability to multitask, work effectively with technology, and handle changing priorities in a fast-paced environment is essential. Travel up to 70-85% may be required.
Qualifications
- Undergraduate degree or its international equivalent in clinical, science, or health-related fields from an accredited institution
- Licensed health-care professional (registered nurse) or equivalent work experience
- Knowledge of ICH-GCP/ISO14155, FDA guidance documents, EU directives, local/regional regulations, and drug/device development and clinical monitoring procedures
- Familiarity with clinical/health systems and cultural/professional practices relevant to the country/region where site monitoring activities will occur
- Ability to multitask, work effectively with technology, and handle changing priorities in a fast-paced environment
Skills
- Strong communication and interpersonal skills
- Attention to detail and ability to manage multiple tasks simultaneously
- Proficiency in clinical research software and systems
- Knowledge of regulatory requirements and compliance
Benefits
- Comprehensive benefits package including health insurance, retirement plans, and paid time off
Pay
The annualized minimum base pay for this role is $60,000 USD. The actual salary will be influenced by various factors such as qualifications, skills, competencies, and proficiency for the role.
Schedule
Flexible schedule to accommodate travel and project demands.
Contact Information
To apply, please visit our careers page or contact us at [insert contact information].