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