The Associate Clinical Trial Monitor plays a critical role in ensuring the successful execution of clinical trials. This position involves oversight of trial progress, compliance with protocols, and collaboration with site investigators to maintain high standards of Good Clinical Practice (GCP) and regulatory requirements.
Key Responsibilities in the Role
As an Associate Clinical Trial Monitor at BMS, your primary responsibilities include:
- Site Management and Oversight
- Identifying and assessing potential investigators and sites for clinical trials.
- Conducting pre-study and initiation visits to provide protocol-specific training.
- Monitoring on-site and off-site activities to ensure compliance with protocols and regulatory guidelines.
- Data Integrity and Quality Assurance
- Ensuring the accuracy and completeness of clinical trial data submitted by sites.
- Addressing and resolving issues at study sites while maintaining the safety of participants.
- Managing database lock timelines and ensuring timely access to electronic data capture (eDC) systems.
- Regulatory and Administrative Support
- Supporting Ethics Committee submissions and regulatory compliance audits.
- Assisting in the preparation of study initiation materials and equipment calibration tracking.
- Coordinating site closure activities upon completion of protocol visits.
- Training and Relationship Building
- Developing strong relationships with site personnel and providing continuous training.
- Acting as a primary point of contact for internal and external stakeholders.
Qualifications and Skills
Educational Background:
- A Bachelor’s degree in Life Sciences or an equivalent field is required.
Professional Experience:
- Minimum 1 year of relevant clinical research experience with the ability to work independently.
Key Skills:
- Strong understanding of ICH/GCP guidelines and local regulations.
- Excellent interpersonal and communication skills to build strong site relationships.
- Ability to manage multiple protocols and maintain a flexible work schedule, including travel.
- Competence in data analysis, problem-solving, and decision-making.
