Roger Trinh Talent Solutions is partnering with a growing Biopharmaceutical company with a presence in Texas. Our client seeks a Remote In-House Clinical Research Associate to oversee and manage clinical trial operational activities: monitor the progress of trial tasks at clinical site(s) and CRO/vendors; ensure deliverables are executed on time under approved budget and in a regulatory compliant manner. This role is reporting to the Vice President of Scientific Affairs.

Key Responsibilities:

• Liaison with management staff to ensure ALL trial activities are compliant with protocol, local regulations, Code of Federal Regulations (CFR), ICH, and GCP guidance
• Manage site and vendor activities to ensure GCP compliance, including monitoring recruitment, data entry accuracy against source data, kit and sample shipment, and pharmacy activities; Answer operational questions from the site(s) and CRO/vendors; follow up and resolve queries and issues. Review field CRA monitoring reports. Seek supervisor/clinical team members’ input internally as needed.
• Carry out document management tasks to ensure Trial Master Files are collected and organized based on regulatory requirements and work closely with QA to ensure GCP compliance of TMF.
• Assist QA in SOP/WI development; assist QA in ensuring audit-ready files
• Answer site and vendor questions regarding trial operational and logistical matters
• Assist site(s) on strategies/activities to enhance recruitment/retention
• Participate in the review of protocol/amendment, study plans, site-level documentation, clinical data QC, and reports 
• Conduct  site monitoring visits (including but not limited to site initiation closeout visits) either alone or accompany field CRA as needed
• Participate in Clinical vendor and clinical site evaluation that includes quote/budget review and negotiation and site initiation visits (SIV)
• Identify project risks and develop mitigation and contingency plans for management review.
• Ensure a positive and collaborative work environment with the site and vendors. Supports and communicates effectively.
• Keep senior management updated on progress and challenges and serve as liaison between clinical site(s) and external vendors.
• Support preparation of trial status, data, and other info for internal and external presentations; Participate in cross-functional meetings and process improvement initiatives across the departments
• Additional tasks as assigned

Requirements:

• Strong work ethics, experience, and a good understanding of regulatory requirements and GCP/ GxP
• B.S or higher degree in a life science discipline, a registered nurse certification, or equivalent, with 5+ years of oncology clinical trial experience (including full trial cycle: site selection, activation, data collection, database lock, site close out)
• Preference is given to candidates with prior experience working with large institutional oncology centers on cell therapy trials who have conducted site monitoring visits (initiation, interim, closeout)
• Proficient in using electronic data capture (EDCs), Trial Master Files (TMFs)
• Strong experience in managing clinical site and central lab service vendor activities and coordination
• Great attention to detail and data/document evaluation skills
• Ability to multi-task and adjust priorities while working with multiple CRAs across multiple sites, work independently in a matrix team environment across parties
• Ability to operate day-to-day work independently in a GCP-compliant manner based on general instructions on assignments and as outlined in protocol and study plans
• High proficiency with all Microsoft applications, including Word, PPT, Excel, Outlook, Teams
• Excellent interpersonal, collaborative and time management skills
• Business fluent in English, Excellent oral and written communication skills across all levels of the organization
• Able to travel domestically and internationally as needed (~20-30%)
• Reside in Houston or Texas, preferred

If you would like to join a dynamic growing team, apply now. Our client has excellent benefits and offers a competitive salary. Please feel free to apply.