What You’ll Do Here
• Ensure the confidentiality of clinical trial participants and sponsors is respected.
• Supervise and/or oversee all study related procedures.
• Act as a resource to indirect reports as well Clinical Operations team members.
• Oversee trial progression and communications in regard to the trial’s progression to clients, internal departments, etc.
• Participate in protocol and ICF reviews.
• Coordinate operations to meet protocol requirements and pre-defined study timelines. Pro-actively define any needs required to accomplish timelines.
• Ensure the creation of study specific SOPs, trainings or other materials as needed for study specific procedures.
• Conduct protocol trainings and/or coordinate any required training(s) on study specific procedures.
• Ensure On-site file(s) are complete and accurate.
• Approve staffing designs and review staffing schedules to ensure sufficient staffing requirements are met based on protocol needs.
• Assure the study Investigational Product (IP) is received and dispensed in lieu with study timeline requirements.
• Participate in SOP revisions.
• Prepare for, participate in and/or act as a liaison for audits conducted by study sponsors, Quality Assurance (QA) and regulatory agencies.
• Coordinate study monitoring. This may include but is not limited to: communications with the monitor, providing study source, responding to monitor queries and coordinating monitor visits.
• Perform protocol specific activities.
• Record adverse events and concomitant medication use and follow-up on open adverse events until resolution.
• Obtain and document study related events and data in compliance with GCP/SOPs.
• Track enrollment status and appropriate document enrollment changes.
• Review of subject eligibility for participation.