Primary Duties and Responsibilities:
- Understand and interpret clinical trial study protocols to design and develop calendars.
- Interpret clinical trial agreements and sponsor budgets to develop site budgets for the protocol.
- Design and develop case report forms for clinical trial study protocols.
- Develop familiarity with Advarra’s Clinical Trial Management Software (CTMS) and Electronic Data Capture (EDC) software to utilize related functionalities in designing and developing calendars, budgets, financials, and case report forms.
- Work closely with the reporting manager to complete daily/weekly calendars, budgets, financials, and/or case report forms design to meet predetermined quality criteria.
- Utilize internal case management software and other reporting software to ensure that daily/weekly work assignments are appropriately tracked and completed.
- Actively participate in team meetings and contribute meaningfully to discussions related to specific customer cases and/or protocols.
Position Requirements:
- Knowledge of clinical research methodology, industry regulations, and Good Clinical Practice guidelines related to human research.
- Ability to work independently as well as in a team environment.
- Good organizational and administrative abilities.
- Familiarity with MS Office and various business software.
Preferred Experience:
- 0-1 year work experience in areas such as:
- Clinical trial coordinator at site
- Clinical data management
- Pharmacovigilance
- Records management
Key Personal Attributes:
- Highly personable nature that fosters teamwork.
- Excellent communication skills, both oral and written.
- High energy and positive attitude towards working in a culturally diverse environment.
- Passion for ensuring outstanding customer support with a solutions-oriented attitude.
- Proactive and takes ownership in all tasks from start to finish.
Working Hours:
- Monday-Friday, 9:00 a.m. to 6:00 p.m.