Clinical Research Associate – In House

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 tot his job