To support the development of clinical research services that enhance research effectiveness and timelines, and which are specific to the software applications (Clinical Trial Management Software as well as Electronic Data Capture software) of Advarra.
Job Duties & Responsibilities
- 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.
Location
This role is open to candidates working remotely or hybrid in Bengaluru, India.
Basic Qualifications
- Knowledge of clinical research methodology, industry regulations and Good Clinical Practice guidelines related to human research.
- Expected to work independently, as well as in a team environment.
- Good organizational and administrative abilities.
- Familiarity with MS Office and various business software.
Preferred Qualifications
- Preferred: 0-1 year work experience in job areas such as:
- Clinical trial coordinator at site.
- Clinical data management.
- Pharmacovigilance.
- Records management.
Physical and Mental Requirements
- Sit or stand for extended periods of time at a stationary workstation.
- Regularly carry, raise, and lower objects of up to 10 lbs.
- Learn and comprehend basic instructions.
- Focus and attention to tasks and responsibilities.
- Verbal communication; listening and understanding, responding, and speaking.
