In House CRA

Position SummaryWe 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 ResponsibilitiesProvide 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.QualificationsBachelor’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 ExperiencePrevious 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 CompetenciesClinical trial operationsICH-GCP complianceSite management and supportEssential document managementTMF/eTMF oversightData and issue reviewRisk identification and escalationCross-functional collaborationCommunication and stakeholder managementOrganization and attention to detail