Clinical Research Associate

Responsible for the oversight of the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).

Requirements

• Identifies new potential Investigators, through ongoing collaborations with internal and external stakeholders.
• Assesses potential Investigators and their sites to ensure they have the resources and capabilities to conduct clinical trials.
• Develops Site relationships (incl. Contract Research Organization related issue management and non- registrational /Investigator Sponsored Research Studies).
• Recommends sites during the site feasibility and/or site selection process
• Conducts pre-study visit as appropriate.
• Conducts initiation visits to ensure Investigator and site personnel receives adequate protocol specific training prior to site activation.
• Reviews site activities and quality through on-site and off-site visits.
• Conducts monitoring activities and ensures safety and protection of study subjects as per the monitoring plan, BMS procedural documents, protocol, ICH/GCP Guidelines and other local regulations as applicable.
• Perform Unblinded Site Monitor activities to protect the blind of the study by acting as secondary monitoring source separate from the blinded monitor.
• Oversees activities of site personnel over whom there is no direct authority.
• Motivates/influences the site to meet study objectives, including enrolment and retention goals.
• Demonstrates flexibility and adaptability when communicating with different stakeholders utilizing the most appropriate communication method.
• Anticipates, identifies and proactively supports site in resolving issues as they occur.
• Proactively identify and resolve potential problems at both site and country level.
• Engage with Clinical Trial Manager and/or line management to assist in the resolution of more complex issues.
• Contribute significantly to study team and coaches site staff to enhance site and hub performance.
• Serve as a key resource for colleagues, by providing guidance, leading training and mentoring to other team members through a mentoring process using informal and/or formal presentations.
• May assist line management with conducting monitoring authorizations and ongoing assessments

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Visa Sponsorship
• Four Day Work Week
• Generous Parental Leave
• Tuition Reimbursement
• Relocation Assistance