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
- Assesses potential Investigators and their sites to ensure they have the resources and capabilities to conduct clinical trials
- Develops Site relationships
- 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
- Performs Unblinded Site Monitor activities to protect the blind of the study by acting as secondary monitoring source separate from the blinded monitor
- Serves as a point of contact for Sites
- Provides trainings to sites
- Performs site closure activities when all required protocol visits and follow-up are completed
- Manages multiple protocols, across multiple therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory
- Ensures completeness and quality of data submitted from study sites
- Ensures eCRF data is available and current by using the available systems to follow site activities
- 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
- Appropriately documents and promptly escalates serious or persistent outstanding issues to management and project team
- Initiates, recommends, documents and communicates corrective actions as needed and follows up to ensure corrective/preventive actions based on root cause analysis are implemented
Benefits
- Competitive salary
- Benefits package
- Paid time off
- 401(k) matching
- Retirement plan
- Visa sponsorship
- Four-day workweek
- Generous parental leave
- Tuition reimbursement
- Relocation assistance
