Clinical Trial Associate

What you'll be doing

• Assists in eTMF (electronic Trial Master File) filing and administration by submitting documents and/or files, conducting document review, supporting document query resolution, ensuring completeness, and conducting final site level review along with final document collection
• Supports study team with functionality and use of TMF in accordance with study-specific TMF Plan, SOPs, and study-specific processes
• Coordinates logistics and planning of meeting, events, and training
• Assists in the dissemination of announcements and training materials related to clinical system updates and enhancements, as required
• Participates in project team meetings, prepares meeting minutes, and maintains action/decision logs

What we are searching for

• 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
• 0 to 2 years of practical experience with clinical trial administration (e.g. - Inhouse CRA, CTA, site administration, clinical monitoring) preferred
• 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 deliverables, and task ownership
• Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities
• Knowledge of International Conference on Harmonization (ICH)/Good Clinical Practices (GCP) and/or ISO14155 requirements as well as detailed knowledge of the relevant country specific regulatory requirements for conducting clinical trial

Pay and benefits

Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The annualized minimum base pay for this role is $44,000.00 USD. 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.