In House CRA

Position Summary We are seeking an experienced and detail-oriented In-House Clinical Research Associate (CRA) to support the planning, conduct, and oversight of clinical trials. The In-House CRA will work closely with Clinical Operations, CRAs, Clinical Trial Managers, Project Managers, investigators, and other cross-functional teams to ensure clinical studies are conducted in accordance with the protocol, ICH-GCP, applicable regulations, and company SOPs. This position provides centralized clinical trial support and oversight, with a strong focus on trial documentation, site support, data review, study tracking, and communication with clinical sites and field-based CRAs. Key Responsibilities • Provide centralized support to clinical study teams and field CRAs throughout the study lifecycle. • Support study start-up activities, including collection and review of essential documents, site activation, and regulatory documentation. • Assist with site identification, feasibility, selection, and activation activities. • Perform ongoing review and tracking of essential documents within the Trial Master File (TMF) and Investigator Site Files (ISF). • Conduct remote review of clinical trial data, including identifying discrepancies, trends, missing data, and potential protocol deviations. • Support site monitoring activities by reviewing monitoring reports, follow-up items, action items, and outstanding issues. • Maintain study trackers for site activation, enrollment, monitoring visits, essential documents, deviations, queries, and other study metrics. • Communicate regularly with clinical sites and field CRAs to resolve study-related issues and ensure timely completion of deliverables. • Assist with preparation and distribution of study materials, meeting minutes, newsletters, and other study communications. • Support Clinical Trial Managers and Project Managers with study status reports and operational metrics. • Review and follow up on site action items and outstanding documentation. • Assist with preparation for investigator meetings, site initiation activities, and study close-out activities. • Ensure clinical trial activities comply with the protocol, ICH-GCP, applicable regulations, and sponsor/CRO SOPs. • Identify potential risks and escalate significant issues to the appropriate study team members. • Participate in study team meetings and contribute to continuous improvement initiatives. • Maintain accurate and timely documentation of all study-related activities. Qualifications • Bachelor's degree in life sciences, nursing, pharmacy, or a related scientific/healthcare discipline. • 1+ years of clinical research experience, preferably within a CRO, pharmaceutical, biotechnology, or clinical research environment. • Experience supporting clinical trials from study start-up through close-out preferred. • Working knowledge of ICH-GCP, FDA regulations, and clinical trial processes. • Experience with TMF/eTMF systems and clinical trial management systems (CTMS). • Familiarity with EDC, eCOA, IWRS/IRT, safety databases, and other clinical trial technologies preferred. • Strong organizational and time-management skills. • Excellent written and verbal communication skills. • Strong attention to detail and ability to manage multiple priorities. • Ability to work effectively in a cross-functional and geographically dispersed team. • Proficiency with Microsoft Office, particularly Excel, Word, Outlook, and Teams. Preferred Experience • Previous experience as a CRA, In-House CRA, Clinical Trial Assistant, or Clinical Research Coordinator. • Experience supporting Phase I–III clinical trials. • Experience with remote/centralized monitoring activities. • Experience working directly with sponsors and clinical sites. • Knowledge of risk-based quality management and centralized monitoring approaches. Key Competencies • Clinical trial operations • ICH-GCP compliance • Site management and support • Essential document management • TMF/eTMF oversight • Data and issue review • Risk identification and escalation • Cross-functional collaboration • Communication and stakeholder management • Organization and attention to detail