Senior Clinical Research Associate (Contract)

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.