Senior Clinical Research Associate (Contract)
Premier Research
Summary
Premier Research is looking for a Senior Clinical Research Associate (Contract) to join our Clinical Monitoring, Site Management and SSU team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics.
Job description
What You'll Be Doing
- Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan (CMP) timelines
- Responsible for the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP/ISO14155, protocol and client requirements
- Monitors (remote, on site or other approved mode of monitoring) with a focus on data integrity and subject safety in accordance with local/regional laws and country specific regulations
- Plans day-to-day activities for monitoring of a clinical study and sets priorities per site
- Prepares for and conducts on site and/or remote qualification, study initiation, interim monitoring, dosing observation, and close out monitoring visits as directed per CMP
- Works with the Clinical Lead or equivalent to enhance and proactively manage site visits and trial issues during the monitoring phase
What We Are Searching For
- Preferred Therapeutic Areas: Oncology, CNS, Dermatology, and Rare Disease monitoring experience highly prioritized
- Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required
- Patient facing, study coordinating experience preferred
- Knowledge of ICH-GCP/ISO14155, FDA Guidance Documents, EU Directives, local/regional regulations, and drug/device development and clinical monitoring procedures
- Knowledge of clinical/health systems as well as knowledge of cultural/professional practices appropriate to the country/region where site monitoring activities will be conducted
- Ability to multitask and work effectively with technology and people in a fast-paced environment with changing priorities, self-starter
- Travel up to 70-85%
- This is a full-time contract position for 12 months.
Requirements
- Undergraduate degree or international equivalent in clinical, science, or health-related field, or licensed health-care professional (e.g., registered nurse), or equivalent work experience
- Knowledge of ICH-GCP/ISO14155, FDA Guidance Documents, EU Directives, and local/regional regulations
- Knowledge of drug/device development and clinical monitoring procedures
- Knowledge of clinical/health systems and cultural/professional practices appropriate to the country/region
- Ability to multitask and work effectively with technology and people in a fast-paced environment
- Self-starter
- Travel up to 70-85%
- Preferred: Oncology, CNS, Dermatology, and Rare Disease monitoring experience
- Preferred: Patient facing, study coordinating experience
Benefits
- Flexible work environment
- Professional development opportunities
Company overview
Premier Research International LLC is a global leader in clinical research and consulting services dedicated to helping biotech, specialty pharmaceutical, and medical device innovators transform breakthrough science into life-changing therapies. Founded in 1989, the company specializes in addressing trial complexity, overcoming development hurdles, and demonstrating product value through integrated end-to-end solutions. With deep therapeutic expertise across oncology, hematology, immunology, rare diseases, cell and gene therapy, and women's health, Premier Research leverages innovative technology and operational proficiency to deliver accelerated development timelines. The company operates globally with over 2,000 employees across more than 70 countries, managing clinical trials from preclinical planning through commercialization. Premier Research's mission focuses on turning brilliant ideas into new medical treatments by providing personalized clinical research, product development, and consulting services that help answer unmet patient needs across a broad range of medical conditions.