In compliance with study documents, SOPs and local regulatory requirements, the Clinical Research Associate performs in-house on-site study monitoring within budget and timelines.

Key Responsibilities

- Participates in conception and writing of study documents Monitors clinical trials to ensure
compliance to ICH-GCP, Standard Operating Procedures, Local Regulatory Requirements and study procedures,
- Identifies potential investigators and qualify sites for clinical studies
- Supports preparation of Ethics Committee and local regulatory submissions
Trains investigators on study procedures including but not limited to CRF completion, query resolution and source data verification
- Performs source data verification during monitoring visits,
- Ensures quality and integrity of data
- Performs selection, initiation, monitoring and close-out visits
- Writes visit reports in accordance to SOPs
- Performs Maintenance and verification of investigator site files
- Prepares essential documents and follow up on collection of these documents
- Ensures that investigational study supplies can be shipped and perform accountability
- Liaises with the Principal Investigator, study team and sponsor
- Organizes / attends investigator meetings, and other study meeting when necessary
- Provides support to the Project Manager whenever necessary
- Assists in SOP review and updates

Qualifications:

- University degree in pharmacy, medicine, health sciences, bioengineering or related field
- CRA certification and/or prior experience as a CRA in the pharmaceutical industry, in the medical device industry or in a CRO
- Experience in study start-up management
- Deep knowledge of Good Clinical Practices standards (ICH-GCPs and/or ISO 14155)
- Rigorous, organizational, priority manamanagement, decision-making and problem-solving skills
- Reactivity, autonomy, dynamism and motivation
- Good Communication skills in English
Availability to travel domestically and i