In-House Clinical Research Associate II, Sponsor-Dedicated (Contract)

Premier Research Group; Clayton (NC); Teletrabalho; USD 70 000 - 90 000; Tempo integral

Resumo da oferta

Premier Research is seeking an In-House Clinical Research Associate I, Sponsor-Dedicated (Contract) to join our FSP team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics.

This role emphasizes remote monitoring and collaboration with cross-functional teams. Bachelor’s degree and 3–5 years of trial experience are preferred; the contract lasts 12 months with potential renewal.

Qualificações

• Bachelor's degree in clinical, biological, scientific, or health-related field or equivalent.
• 3 to 5 years of practical experience in clinical trials.
• Experience in Neurology or Psychiatry, including work with Schedule I controlled substances, is highly preferred.
• Excellent English verbal and written communication skills.
• Proven ability to deliver quality and timely deliverables with strong customer focus.

Responsabilidades

• Carry out remote monitoring of clinical trials.
• Serves as the secondary contact for sites supporting CRAs.
• Responsible for the proper reporting and follow up of SAEs and ensures all reportable events are identified, clearly documented and reported per protocol as well as applicable requirements and regulations.
• Ensures any identified non-compliance issues are addressed, clearly communicated, documented and escalated as required through monitoring visits, analyzing study metrics, and general study data overview.
• Assists with audit/inspection readiness, study start-up activities, data listing reviews, monitoring visit support and issue resolution.

Conhecimentos

English proficiency

Communication skills

Study coordination

Formação académica

Bachelor's degree in clinical/biological/health field

Descrição da oferta de emprego

Premier Research is looking for a In-House Clinical Research Associate I, Sponsor-Dedicated (Contract) to join our Functional Services Provider (FSP) 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.

As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Partners with cross-functional team members and study sites throughout all phases to offer support of numerous trial elements for the clinical operation teams.

Responsibilities

• Carry out remote monitoring of clinical trials
• Serves as the secondary contact for sites supporting CRAs
• Responsible for the proper reporting and follow up of SAEs and ensures all reportable events are identified, clearly documented and reported per protocol as well as applicable requirements and regulations
• Ensures any identified non-compliance issues are addressed, clearly communicated, documented and escalated as required through monitoring visits, analyzing study metrics, and general study data overview
• Assists with audit/inspection readiness, study start-up activities, data listing reviews, monitoring visit support and issue resolution

Qualifications

• Experience in Neurology or Psychiatry, including work with Schedule I controlled substances, is highly preferred
• Bachelor's degree, or international equivalent from an accredited institution, preferably in a clinical, biological, scientific, or health-related field or equivalent combination of education, training and experience
• 3 to 5 years of practical experience in clinical trials. Participate in study-specific meetings, teleconferences and training as needed
• Demonstrates excellent English verbal and written communication skills
• Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverable, and task ownership
• This is a 1099 12-month contract position with the potential to extend and renew after 1 year.

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