What You’ll Do:
• Conduct clinical studies according to FDA/GCP and ICH regulations and guidelines.
• Provide medical care to patients, always ensuring patient safety comes first.
• Schedule subject visits within protocol windows, ensuring scheduling capacity is maximized.
• Perform all defined study activities (i.e., informed consent, screening, and protocol procedures which include but not limited to vital signs, pregnancy tests,
height, weight, ECG’s, blood samples, etc.).
• Record all patient information and results from test as per protocol on the required forms.
• Where required, may complete IP accountability logs and associated information.
• Report suspected of non-compliance to relevant site staff.
• Ensure that IRB approval is obtained prior to study initiation and IRB requirements are met throughout the study.
• Promote the company and builds a positive relationship with patients to ensure retention.
• Attend site initiation meetings and all other relevant meetings to receive training on protocol.
• Review the plan for study conduct for multiple assigned studies and determine how to accomplish. Identify and communicate any obstacles
impeding efficient study conduct.
• Accurately collect and document data. Ensure correct study documents and Computer generated forms are used in compliance with protocol.
• Ensure that timelines are met by working with relevant staff.
• Monitor safety and well-being of all study participants through direct and indirect interaction with subjects, and communicate problems to relevant
stakeholders.
• Accelerated Enrollment Solutions is a business unit of Pharmaceutical Product Development, LLC, a Delaware limited liability company (“PPD”), collectively made up of Acurian, Inc. and Synexus, each a subsidiary of PPD.
• Perform clinical assessments of participants, monitor laboratory safety reports, and communicate any serious or potentially serious adverse events as per the company procedure.
• Serve as a primary point of sponsor contact for all research activities for studies assigned.
• Ensure all communications are documented and shared with the appropriate team members.
• Act as a back-up to direct people manager. This includes but is not limited to, overseeing and assigning work to team members, scheduling, and monitoring time. Involved in the interview and hiring process of new team members. Assist in the training of new team members and providing mentoring. Provide input into evaluations performance reviews of team members. Perform other study related duties as qualified by documented training.