Clinical Research Associate
General Position Overview:
The Clinical Research Associate (CRA) is a key member of the clinical team, providing support in the planning and management of one or multiple clinical trial(s). Responsibilities include assisting in vendors management, sites management, development of study plans, informed consent, performing site visits (as needed), and interfacing with internal/external team members. Levels will be dependent on the years of experience.
- Serves as the primary liaison with research sites, CROs; provides support to the day-to-day conduct of the study, resolves problems associated with the study; identifies areas of concern and escalates to the Study Operations team as appropriate
- Provides administrative and logistical support as needed (e.g., study tracking and supplies management, reviewing essential regulatory documents including site visit reports as needed, maintaining study updates to internal team, etc.)
- Participates in the design of study manuals, informed consent, study plans, study communications and presentations, etc.
- Participates in site start-up, interim and close-out activities, etc.
- Interacts with the clinical study sites to resolve data queries and/or data entry errors, and obtain additional information on potential serious adverse events
- Trains and assists site coordinators, investigators, CRAs, CRO (as applicable) in data collection according to the protocol requirements; serves as a resource to site coordinators, investigators and other staff members; monitors and tracks progress and obstacles
- Participates in data review as needed
- Ensures studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures
- Assists in identification and selection of CROs and third-party study vendors as needed
- Supports additional study activities including updating timelines, providing invoice review and updates to budgets, and risk mitigation plans as appropriate
- Assists in the development and implementation of recruitment strategies
- Conducts Sponsor quality monitoring/oversight visits to sites and/or CRAs performance assessment in adherence to GCP, corporate SOPs and protocol as needed
- Participates in the departmental initiatives, policies, SOPs
- Performs other work-related duties as assigned
- Minimum BA/BS or equivalent degree in scientific discipline; preferred and/or training or equivalent combination of education and experience
- Minimum 2+ years experience in the role of Clinical Research Associate preferred
- Experience in oncology preferred
- Experience in interactions with outside vendors, e.g., CROs
- Demonstrates some understanding of medical/therapeutic area knowledge and medical terminology is a plus
- Experience in the preparation, monitoring, and execution of clinical studies is a plus
- Understanding of clinical research operations, including interpretation and implementation of FDA regulations/ICH/GCP guidelines, is required
- Strong attention to detail and excellent organization skills
- Strong interpersonal skills and communication skills (both written and oral)
- Excellent sense of urgency to deliver at/surpass study conduct targets
- Computer skills including proficiency in the use of Microsoft Word, Excel, PowerPoint, and organization tools
Tizona Therapeutics is an Equal Opportunity Employer. We value diversity and are committed to providing employees a workplace free of discrimination and harassment. All employment decisions are based on qualifications, merit and business needs.