TFS HealthScience

Clinical Research

• Develop and maintain strong relationships with key personnel at clinical trial sites, including principal investigators, site coordinators, and other site staff
• Serve as a bridge between the sponsor and clinical trial sites, ensuring clear and timely communication of study protocols, updates, and key information
• Conduct Monitoring Oversight Visits and regular site engagement activities to ensure high-quality trial execution
• Design customized site-level engagement plans to help drive enrollment and support timely patient recruitment
• Collaborate with CRO CRAs and Medical Science Liaisons to identify, mitigate and resolve site-level challenges
• Participate in feasibility and site qualification visits, collaborating with CRO representatives
• Represent the sponsor at local and regional patient advocacy or support group meetings when needed
• Track and report site engagement activities, enrollment status, and performance metrics

Clinical Research Manager

Data Scientist

• Responsible for Clinical Data Management activities for assigned studies
• Mentor Clinical Data Managers and Senior Clinical Data Managers on specific Data Management topics
• Act as Lead Clinical Data Manager and Project Lead for Biometric-only projects
• Coordinate work of Clinical Data Management staff assigned to projects
• Plan client deliverables and manage project budgets (incl. PFU/revenue files)
• Prepare and distribute periodic project progress reports and oversee client correspondence
• Coordinate receipt and processing of project information (coding dictionaries, format libraries, database specs)
• Direct and oversee project-specific initiation, orientation, and kick-off meetings
• Review study protocol and develop or review CRFs
• Develop database, define and program edit checks, and prepare related DM documentation
• Develop Data Management Plan, Data Management Report, and Data Validation Plan
• Develop Data Entry Instructions/eCRF completion guidelines and coordinate validation of database and trial settings
• Perform CRF handling, data cleaning, and query handling
• Train and support Clinical Data Associates, Clinical Data Managers, CRAs, and study teams
• Ensure completion of Quality Control tasks and database closure, and file/archive essential documents
• Provide metrics and status updates to senior management and sponsors
• Coordinate SDTM mapping with senior programmer when needed
• Perform system validation, create test scripts, and perform UAT of ePROs
• Contribute to process improvements and provide input into proposals and Bid Defense meetings

Principal Clinical Data Manager

QA Engineer

• Ensure the Annual Audit Plan is prepared, followed and maintained along with the Audit Progress Report and tracking of all audit types
• Prepare, conduct and follow up on all types of internal and external GxP audits
• Support and guide operational staff in preparing for customer audits and inspections and host/facilitate customer audits
• Review and approve audit reports for other quality management personnel and act as Quality Lead Auditor when applicable
• Assist in preparing investigational sites and TFS for regulatory inspections; provide inspection readiness strategy and manage teams during inspections
• Oversight, management and support of Quality Issues including review and approval of Risk Reviews, CAPA and effectiveness verification
• Oversight and management of Complaints, Potential Serious Breach and Potential Fraud and Scientific Misconduct investigations
• Contribute to development and continuous improvement of the TFS Quality Management System and related QMS documents
• Provide quality management advice and support to internal staff, departments and external clients; host Quality Committees
• Ensure all GxP vendors are assessed and work with Vendor Management to resolve issues
• Responsible for audit metrics and assisting with Quality Management metrics
• Assist with proposals, costings and business development activities; review MSAs/Quality Agreements and manage RFIs/RFPs
• Act as trainer for Quality Management and TFS staff; prepare and distribute the Regulatory Intelligence Newsletter quarterly
• Maintain required knowledge of applicable regulations and company GxP standards and procedures
• Participate in internal meetings and perform other tasks delegated by Senior Director Quality Management within scope of experience

Associate Director, Quality Assurance, GCP Auditor

• Prepare, conduct and follow up on all types of internal and external GxP/GCP audits
• Provide leadership and support in clinical audit activities for internal and external parties (service providers, clinical sites)
• Work with Business Leads to ensure resolution of audit findings/non-compliant issues and approve CAPA plans
• Conduct peer review of audit reports and support operational staff preparing for customer audits
• Host client and regulatory inspections and manage inspection readiness
• Prepare investigational sites and guide staff in developing inspection readiness strategies
• Act as subject matter expert for inspectors and train backroom support teams
• Manage teams during inspections and host regulatory inspections for clients as required
• Facilitate generation and revision of Controlled Documents (Policies, SOPs)
• Support and guide completion of risk assessments and root cause analyses for Quality Issues
• Assist in preparing robust CAPA plans and track them through to completion
• Drive continuous improvement and development of routines to increase quality and compliance
• Assist with business development of external quality and compliance services and attend client meetings
• Provide quality advice and support to internal and external clients
• Lead clinical non-compliance investigations and CAPA implementation; identify systemic gaps and escalate critical issues as appropriate

Senior Manager, Quality Assurance – GCP Auditor

Research Analyst

• Initiation, on-site and/or remote monitoring and close out of study sites during study conduct
• Monitor clinical trials according to TFS and/or sponsor SOPs, GCP, ICH and applicable regulations
• Perform monitoring activities to assess and ensure subject safety, data integrity and quality
• Verify informed consent procedures and protocol compliance to protect study participants
• Review CRFs and source documentation for validity and accuracy
• Work as part of the Strategic Resourcing Solutions (SRS) team to support customer study goals

Senior Clinical Research Associate

• Lead on-site and remote monitoring of clinical trials, ensuring data integrity, patient safety, and regulatory compliance
• Initiate, monitor (on-site and remote), and close out study sites during clinical trials
• Verify informed consent procedures and protocol compliance to protect participants
• Review CRFs and source data to ensure accuracy and completeness
• Oversee management and accountability of investigational products and maintain audit readiness
• Document monitoring visit findings in detailed reports, escalate issues, and update tracking systems
• Collaborate with sites to resolve findings, deliver action plans, and maintain Trial Master File (TMF)

Clinical Research Associate

• Oversee performance of approximately 20 hospital-based sites across the US.
• Provide quality oversight of CRO activities, ensuring compliance with protocol, ICH/GCP, and regulatory requirements.
• Conduct a combination of onsite visits and remote reviews to evaluate study progress.
• Identify operational issues and develop corrective and preventive action plans (CAPA).
• Serve as a liaison between sponsor, CRO, and site teams.
• Contribute to study governance and oversight reporting.
• Review site and CRO performance and prepare corrective action plans to ensure study delivery.
• Role FTE level 0.5–1.0 depending on availability; contract length 6 months; start as soon as practical; travel required.