Clinical Trial Assistant
New
T
TransPerfectClinical research
Source API remote eligibility restrictions: United States, Candidates must be in a workable time zone for the study team.ContractMiddle
Salary not disclosed
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Job Details
- Languages
- English-speaking
- Experience
- Approximately 3 years of experience in clinical research, clinical operations, the pharmaceutical or biotechnology industry, or a CRO.
- Required Skills
- Microsoft ExcelPowerPoint
Requirements
- Have a bachelor's degree in life sciences, healthcare, business, or a related field, or an equivalent combination of education and relevant experience.
- Have approximately 3 years of experience in clinical research, clinical operations, the pharmaceutical or biotechnology industry, or a CRO.
- Have a general understanding of clinical trial conduct and Good Clinical Practice (GCP).
- Be proficient with Microsoft Office, including Word, Excel, PowerPoint, Outlook, and Teams.
- Bring strong organizational skills and the ability to manage multiple priorities, deadlines, documents, and study activities.
- Demonstrate attention to detail and commitment to accurate, complete documentation.
- Have effective written and verbal communication skills.
- Work collaboratively with Sponsors, clinical sites, CRAs, vendors, and internal team members.
- Work independently within assigned responsibilities and escalate questions, risks, or issues appropriately.
- Preferred: experience supporting clinical trials at a CRO, Sponsor, biotechnology or pharmaceutical company, or clinical research site.
- Preferred: experience with TMF, CTMS, electronic document management systems, or other clinical trial technology platforms.
- Preferred: experience maintaining study trackers, meeting minutes, action logs, and clinical trial documentation.
Responsibilities
- Coordinate day-to-day administration of assigned clinical trials with Clinical Operations and study leadership.
- Schedule study meetings and prepare agendas, presentation materials, minutes, action items, and follow-up documentation.
- Maintain study trackers, action logs, metrics, dashboards, investigator information, and site records.
- Communicate with clinical trial sites about routine study activities and documentation as directed by designated team members.
- Collect and organize information for site feasibility, identification, and selection, and support training, investigator meetings, and site initiation activities.
- Track study start-up, site activation, enrollment, monitoring visits, documents, milestones, and deliverables; escalate delays and risks.
- Prepare, review, route, track, and maintain study documents, reference materials, version control, and electronic repositories.
- Support TMF document collection, filing, quality review, reconciliation, and follow-up on missing or incomplete documents.
- Track essential regulatory documents and support clinical trial registry activities, audits, inspections, and quality reviews.
- Coordinate vendor deliverables and help develop or revise Clinical Operations processes, tools, and workflows.
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