Note: The job is a remote job and is open to candidates in USA. Premier Research is a clinical research organization that helps biotech, medtech, and specialty pharma companies develop new medicines, devices, and diagnostics. The Clinical Trial Associate I will support electronic Trial Master File administration, clinical system processes, meeting logistics, training communications, and project team documentation.
Responsibilities
- 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
Skills
- 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
- 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
- 0 to 2 years of practical experience with clinical trial administration (e.g. – Inhouse CRA, CTA, site administration, clinical monitoring) preferred
Benefits
- Health insurance
- Retirement plans
- Paid time off
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