Clinical Trial Associate I

• Maintains Trial Master File (TMF)/electronic Trial Master File (eTMF) in collaboration with the clinical team as defined by the organization’s or Sponsor’s SOPs and all applicable regulatory requirements.

• Reviews site documents and verifies they meet or exceed all company, sponsor, regulatory authority, and ALCOAC standards.

• Conducts follow up with the internal team on TMF queries to ensure timely resolution.

• May assist SSUAs/CRAs with essential document collection and review during startup, maintenance and close out.

• Assists the clinical study team in the tracking and documentation of Investigator's Brochure and safety report distribution as well as other documents/materials sent to sites, e.g. newsletters.

• Supports the CRA/clinical team in liaising with third party vendors to solve and follow-up on issues e.g. on study equipment, translations

What We Are Searching For: 

• Undergraduate degree required, or its international equivalent in nursing, life sciences or medical documentation from an accredited institution

• Fluent verbal and written English

• Knowledge of ICH/GCP preferred

• Solid computer knowledge/skills including MS Word, Excel, PowerPoint and Outlook 

• Excellent interpersonal and listening skills 

Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The actual salary will be influenced based on a variety of factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. We also offer a comprehensive benefits package, which may include health insurance, retirement plans, and paid time off.