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