- Understand and interpret clinical trial study protocols to design and develop calendars. Understand and 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 a familiarity with Advarra s Clinical Trial Management Software (CTMS) and Electronic Data Capture (EDC) software to utilize related functionalities in the design and development of calendars, budgets, financials and case report forms.
- Work closely with reporting manager to complete daily/ weekly calendars, budgets, financials and/or case report forms design to meet with pre-determined quality criteria.
- Understand and 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.
- Expected to work independently, as we'll as in a team environment.
- Good organizational and administrative abilities
- Familiarity with MS Office and various business software
Preferred: 0-1 year work experience in job 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 oral as we'll as written
- High energy and positive attitude towards working in a culturally diverse environment
- A passion for ensuring outstanding customer support with a solutions-oriented attitude.
- Proactive and takes ownership in all tasks from start-to-finish.
Physical and Mental Requirements
- Sit or stand for extended periods of time at stationary workstation
- The employee must occasionally lift and/or move up to 25 pounds.
- Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus
- This position requires regular oral/written interaction with clients, team members and management
