Flexible-Work Clinical Research Associate | Impact & Growth

Novotech; Durham (NC); On-site; USD 70,000 - 140,000; Full time

Job summary

Novotech in Durham, NC is seeking a Clinical Research Associate to build relationships with Principal Investigators and site staff, ensuring efficient and timely management of clinical trials. This role supports regulatory submissions and TMF maintenance in collaboration with IHCRA and RSA.

You will monitor sites per ICH GCP CMP, coordinate site payments, and provide progress updates to the project team. A life sciences degree and CRA experience are preferred; flexible options may apply.

Qualifications

• Must have good time management skills, attention to detail, and be able to work well in a team.
• Must be computer literate.
• Graduate in a clinical or life sciences-related field.
• Relevant experience in allied professions may be considered.

Responsibilities

• Build relationships with Principal Investigators, study coordinators, pharmacists, and trial personnel to ensure smooth management of clinical trials.
• Foster internal and external customer relationships to ensure timely and productive project delivery.
• Collaborate with IHCRA and RSA to prepare site essential documents and support regulatory submissions.
• Understand local and international regulatory requirements for trials relevant to the site.
• Monitor investigational sites per ICH GCP CMP, onsite or remote as needed.
• Protect rights and wellbeing of trial participants and report adverse events promptly.
• Verify data accuracy, manage CRF data and queries per timelines.
• Keep Trial Master File up to date and site payments aligned with CTAs.
• Provide site updates and escalate issues according to SOPs.

Skills

Time management

Attention to detail

Teamwork

Computer literacy

Education

Bachelor's or higher in clinical or life sciences

Tools

Clinical Trial Management Systems

Job description

Novotech in Durham, NC is seeking a Clinical Research Associate to build relationships with Principal Investigators and site staff, ensuring efficient and timely management of clinical trials. This role supports regulatory submissions and TMF maintenance in collaboration with IHCRA and RSA.

You will monitor sites per ICH GCP CMP, coordinate site payments, and provide progress updates to the project team. A life sciences degree and CRA experience are preferred; flexible options may apply.