Clinical Trial Administrator
Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.
We’re looking for an exceptional Clinical Trial Administrator to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.
At Premier Research, we are science-minded and heart-centered. Join us.
As a CTA, you will be responsible for supporting assigned studies in collaboration with global study team members, by executing administrative functions such as minute taking, data entry, tracking, binder creation, and supply distribution. Also responsible for participation in study meetings, essential document review, and Trial Master File (TMF) processing. May also participate in budget negotiation, fee tracking, and amendment processing in accordance with protocol, standard operating procedures, International Organization of Standardization (ISO)/Good Clinical Practices (GCP) and other applicable regulatory requirements. Provides support in start-up, enrollment, follow-up and closure of clinical trial activities.
- Participates in project team meetings, prepares meeting minutes, and maintains action/decision logs
- Procures, maintains, and ships study documents, supplies, and materials in compliance with Standard Operating Procedures (SOPs) and study-specific processes.
- Assists in eTMF 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
- Tracks non-TMF documents and study status in applicable tracking systems
- Reports document collection and tracking issues to functional lead and/or study team, as required
- Supports the Clinical Research Associate (CRA) and site personnel with site level document collection, as requested
- Supports regulatory inspections and/or audits as required
- Maintains account access to applicable study servers and portals where applicable
- Identifies, manages, escalates where appropriate, and resolves site issues effectively
- Communicates functional area study status and provides associated reports to the study team as appropriate
- Reviews and maintains study email folders as applicable, provides correspondence to sites, sponsors, and study team members as needed
- Performs additional duties as assigned
- 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
- Previous CTA experience, preferably gained with a CRO/pharma vs academia
- 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 trials