Senior Clinical Research Associate (Contract)

Premier Research; United States; À distance; USD 85 000 - 120 000; Plein temps

Résumé du poste

Premier Research is seeking a Senior Clinical Research Associate (Contract) to join our Clinical Monitoring, Site Management and SSU team in the United States. The role supports biotech, medtech, and specialty pharma through data integrity, site monitoring, and trial coordination.

Key responsibilities include delivering monitoring reports, ensuring data accuracy per ICH GCP/ISO14155, and planning day-to-day monitoring activities with onsite or remote visits. Travel up to 70–85% will be required.

Qualifications

• Knowledge of ICH-GCP/ISO14155, FDA Guidance Documents, EU Directives, local/regional regulations and drug/device development and clinical monitoring procedures.
• Experience with clinical data systems and site management.
• Ability to multitask in a fast-paced environment with changing priorities and timescales.
• Willingness to travel up to 70-85%.

Responsabilités

• Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines.
• Responsible for 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, onsite or other approved mode) 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 onsite and/or remote qualification, study initiation, interim monitoring, dosing observation, and closeout 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.

Connaissances

ICH-GCP knowledge

FDA/EU guidelines

Study coordination

Travel readiness

Formation

Undergraduate degree in clinical/science

Description du poste

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, onsite or other approved mode of monitoring) with a focus on data integrity andsubjectsafety in accordance withlocal/regional laws andcountryspecificregulations
• Plans day-to-day activities for monitoring of a clinical study and sets priorities per site
• Prepares for and conducts onsiteand/or remotequalification, study initiation, interim monitoring,dosing observation,and closeout monitoring visitsasdirected 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 practicesappropriate tothe country/region where site monitoring activities will be conducted
• Ability to multitask and work effectivelywith technology and peoplein 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