RESPONSIBILITES/DUTIES:

Project Management & Timeline Oversight

• Timeline Tracking: Assist the Study Manager and team in developing and maintaining integrated study timelines (MS Project or equivalent), identifying potential risks to milestones.
• Vendor Oversight: Monitor CRO and vendor deliverables against contractual timelines and Key Performance Indicators (KPIs).
• Meeting Leadership: Lead the planning and execution of internal/external project meetings, including the development of agendas and strategic meeting minutes.
• Process Improvement: Identify gaps in current clinical workstreams and support the development of departmental SOPs and study-specific tools and training to increase efficiency.
• Risk and Issue Management: Documents and escalates clinical trial risks and issues and drives timely follow through and completion.

Financial & Contractual Support

• Budget Tracking: Assist in tracking study expenditure and processing vendor invoices against the approved budget and work orders.
• Contract Lifecycle: Facilitate the routing and execution of Clinical Trial Agreements (CTAs), Master Service Agreements (MSAs), and Statements of Work (SOWs).
• Site Payment Oversight: Manage the site payment tracker, ensuring investigators are paid accurately based on completed enrollment and monitoring report data.

Clinical Operations & Documentation

• TMF Management: Organize, maintain, and archive sponsor-required clinical trial documents (CRFs and essential documents) per ICH/GCP guidelines within the Trial Master File (TMF); Conduct periodic reconciliations between the CRO eTMF and the Sponsor TMF to ensure all essential documents are present and contemporaneously filed; ISF Support: Assist the Sr. CRA in verifying that site-level Investigator Site Files (ISF) are being maintained by the CRO in accordance with the site’s specific GCP requirements; Document QC: Perform quality control (QC) checks on documents uploaded by the CRO to ensure legibility and correct indexing
• Reporting: Assist in tracking and reporting study site and overall program progress, ensuring timely review of site reports and data entries.

Site & Study Support

• Metrics Tracking: Maintain real-time tracking of patient recruitment, enrollment status, and manufacturing schedules for clinical studies.
• Communication: Facilitate streamlined communication between the CRO, medical monitor, regulatory consultants, and clinical sites.
• Document Review: Participate in the development and review of core study documents, including protocols, Informed Consent Forms (ICFs), and Investigational Brochure (IB).

Investigational Product (IP) Coordination

• Supply Management: Coordinate with manufacturing or CMOs to ensure adequate investigational drug supplies are available and maintained at sites based on enrollment demands.
• Accountability: Facilitate the reconciliation of Investigational Product (IP) records to ensure compliance with GCP requirements for product handling and disposal.
• Logistics: Assist logistics department with the shipment and tracking of IP and associated supplies.

Data & Regulatory Support

• eDC Operations: Access EDC database and CRO data systems/platforms to generate, export, and organize data for monitoring and review by Clinical Operations leadership.
• Regulatory Liaison: Support with document maintenance and the preparation of documents for IRB and OHRO submissions.

POSITION QUALIFICATIONS:

Qualifications

• Education: Bachelor’s degree, preferably in a scientific or public health discipline.
• Experience: 1–2 years of experience within a clinical profession or biotech-oriented company. Previous experience with clinical trials or TMF management is highly preferred.
• Technical Skills: Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and MS Project/Smartsheet.
• Experience with SharePoint or Visio is desirable.
• Basic understanding of FDA regulations, ICH-GCP guidelines, other applicable regulatory requirements, and the biologics development process.
• Competencies: Strong analytical and problem-solving skills with meticulous attention to detail.
• Excellent written and verbal communication skills.
• Demonstrated ability to multi-task and work independently in a fast-paced, flexible environment.