Job Description:
• Support the study lead(s) in day-to-day operational management of one or more clinical trials.
• Ensure that investigative sites follow the study protocols, Standard Operating Procedures (SOPs), and regulatory requirements.
• May manage one or more key study vendors including central lab, IRT/RTSM, or CRO.
• Monitor and track study progress, patient recruitment, and data collection at investigational sites.
• Review and verify the accuracy, completeness, and quality of clinical trial data.
• Maintain and update essential trial documentation, including case report forms, regulatory documents, and investigator files.
• Collaborate with investigators, study coordinators, and other site staff to provide guidance and support.
• Identify and escalate any issues or deviations from the study plan to the appropriate parties.
• Assist in the preparation and submission of regulatory documents, such as Institutional Review Board (IRB) submissions.
• Ensure that the trial is conducted in compliance with Good Clinical Practice (GCP) guidelines and relevant regulations.
Requirements:
• Bachelor's degree in a related field (Life Sciences, Nursing, etc.), or equivalent experience.
• 2+ years of clinical operations experience or related drug development.
• Strong knowledge of GCP, ICH guidelines, and regulatory requirements for clinical research.
• Excellent organizational and time-management skills.
• Strong communication and interpersonal skills.
• Ability to work independently and as part of a cross-functional team.
• Proficiency in using Microsoft Office applications, clinical trial management systems, and electronic data capture systems.
• Willingness to travel to investigational sites as required.
• Familiarity with early phase clinical trial protocols and procedures a plus.
• Prior vendor management experience a plus.
Benefits:
Apply Now
Apply Now