In House CRA
hace 10 horas
Des Moines
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