Senior Clinical Research Associate (Contract)

Premier Research • Regional_NC, NC

2d

About The Position

Premier Research is seeking a Senior Clinical Research Associate to join its Clinical Monitoring, Site Management and SSU team. The role supports biotech, medtech, and specialty pharmaceutical companies in developing medicines, devices, and diagnostics. The position is a full-time contract for 12 months and involves extensive travel of up to 70–85%.

Requirements

• Undergraduate degree or international equivalent in a clinical, science, or health-related field from an accredited institution; alternatively, a licensed health-care professional (such as a registered nurse) or equivalent work experience.
• Knowledge of ICH-GCP/ISO 14155, FDA Guidance Documents, EU Directives, local and regional regulations, and drug/device development and clinical monitoring procedures.
• Knowledge of clinical and health systems, as well as cultural and professional practices relevant to the country or region where site monitoring will be conducted.
• Ability to multitask and work effectively with technology and people in a fast-paced environment with changing priorities; must be a self-starter.
• Ability to travel up to 70–85%.

Nice To Haves

• Monitoring experience in oncology, CNS, dermatology, or rare disease; these therapeutic areas are highly prioritized.
• Patient-facing or study-coordinating experience.

Responsibilities

• Deliver quality, timely monitoring reports for sponsor approval according to Clinical Monitoring Plan timelines.
• Ensure the validity, correctness, and completeness of clinical data reviewed and collected at assigned sites in accordance with ICH GCP/ISO 14155, the protocol, and client requirements.
• Conduct remote, onsite, or other approved monitoring focused on data integrity and subject safety, following applicable laws and regulations.
• Plan day-to-day clinical study monitoring activities and set priorities for each site.
• Prepare for and conduct qualification, study initiation, interim monitoring, dosing observation, and close-out monitoring visits onsite and/or remotely, as directed by the Clinical Monitoring Plan.
• Work with the Clinical Lead or equivalent to enhance and proactively manage site visits and trial issues during the monitoring phase.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior