Senior Clinical Research Associate (Contract)

11 Premier Research International LLC; North Carolina; On-site; USD 90,000 - 120,000; Full time

Job summary

Premier Research is seeking a Senior Clinical Research Associate (Contract) to join our Clinical Monitoring, Site Management and SSU team. This role supports biotech, medtech, and specialty pharma clients, helping to translate science into new medicines, devices and diagnostics.

You will monitor data integrity and subject safety in line with ICH-GCP/ISO14155, plan monitoring activities, and collaborate with Clinical Leads to optimize site visits.

Qualifications

• Undergraduate degree in clinical, science, or health-related field or licensed health-care professional.
• Knowledge of ICH-GCP/ISO14155, FDA guidance and EU directives.
• Experience coordinating and monitoring clinical studies.

Responsibilities

• Delivers quality, timely monitoring reports for sponsor approval per CMP timelines.
• Ensures validity and completeness of clinical data as per protocol and client requirements.
• Monitors by remote, on-site or approved mode focusing on data integrity and patient safety.
• Plans day-to-day monitoring activities and sets site priorities.
• Prepares and conducts site qualification, initiation, interim monitoring, dosing observation, and close-out visits per CMP.

Skills

Monitoring experience

ICH-GCP knowledge

FDA/EU regulatory knowledge

Data integrity

Multitasking

Travel willingness

Clinical monitoring

Education

Undergraduate degree in clinical/science/health

Licensed healthcare professional (RN or equivalent)

Tools

EDC systems

Job description

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. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here.

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.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status

Premier Research is a global clinical research, product development, and consulting company. We are dedicated to helping biotech, specialty pharma, and MedTech innovators transform life-changing ideas and breakthrough science into new medical treatments. Our team is inspired by this common purpose. Premier is a place where you can change lives, and feel rewarded and celebrated. We aim high - we will not stop until we reach our goals. And we care about each other, about our customer and partners, and, most importantly, about all the patients that we touch with our work.