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Biotech
Perform site monitoring and site management for clinical studies, ensuring regulatory compliance, patient safety, data integrity, CRF review, SAE tracking, audit readiness, and timely trip reports. Coordinate vendors, regulatory submissions, training, and local project tasks; travel to sites as required.
Biotech
Manage clinical trial sites per SOPs, ICH GCP and sponsor requirements. Perform on-site monitoring (PSV, SIV, routine, close-out), SDV, query resolution, regulatory/eTMF maintenance, SAE reporting, IP accountability, visit reports, and site training. Collaborate with study teams, use CTMS/eClinical systems, support investigator management and ensure audit readiness while traveling to sites (~60%).
Biotech
Perform eTMF review and management for clinical studies, ensuring audit readiness and regulatory compliance (GCP/ICH). Classify documents, perform QC, map sponsor TMF indices, track missing artifacts, prepare for audits/inspections, support study teams with status reports, and contribute to quality and process improvement initiatives.
Biotech
Responsible for clinical site management, monitoring trials, ensuring compliance with regulations, and maintaining study integrity while managing travel and resources effectively.
Biotech
Coordinate and manage site start-up activities for clinical studies, ensuring regulatory compliance (ICH/GCP, IRB/IEC), site selection, document collection, site activation, vendor coordination, contract and budget negotiations, TMF maintenance, and stakeholder communication. Serve as primary site contact, mentor junior staff, and support CRA activities through activation and closeout as needed.
Biotech
The role involves managing site start-up activities, regulatory submissions and compliance, mentoring junior team members, and documenting processes and timelines for clinical trials.
Biotech
Manage end-to-end clinical trial operations including start-up through database lock, site selection, regulatory/ethics submissions, budget and vendor oversight, monitoring strategy, KPI tracking, risk management, and client-facing communications in global trials.
Biotech
The Site Navigator II manages site identification, feasibility, and start-up activities, coordinates regulatory submissions, and acts as a point of contact for investigative sites.
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Biotech
Provide nursing care to healthy volunteer participants in Phase I clinical trials: obtain consent, perform assessments (vitals, ECGs, telemetry, venipuncture), administer investigational compounds, document adverse events, and follow protocol and emergency procedures in a fast-paced clinic environment.
Biotech
Support external/vendor clinical data management across study lifecycle: develop/maintain Vendor Data Plans, validate edit checks and reports, reconcile and QC lab and third-party data, manage discrepancies and queries, collaborate with vendors and cross-functional teams, and ensure compliance with SOPs, ICH-GCP, and sponsor requirements.
Biotech
Coordinate site start-up activities and oversight to ensure compliant, timely site activation. Serve as primary site contact, manage regulatory and TMF documentation, support IRB/IEC submissions, perform feasibility and outreach, assist CRA teams, negotiate site contracts/budgets, perform CRF review/data validation, and mentor junior colleagues as needed to meet study milestones under ICH/GCP and local regulations.
Biotech
Manage UK and selected EMEA employee benefits programs, pensions, and flexible benefits portal; ensure compliance, vendor management, renewals, budgeting, reporting, and deliver regional/global benefits projects while coaching junior team members.
Biotech
Perform site monitoring including initiation, routine visits and closeouts to ensure protocol and regulatory compliance (GCP). Manage site activities, support feasibility and investigator recruitment, track/report SAEs, mentor junior staff, and coordinate vendors to protect patient safety and data integrity.
Biotech
Coordinate and support Phase I clinical trials by maintaining project documents, tracking timelines, managing CTMS/eTMF, running study meetings, supporting start-up and vendor activities, acting as a point of contact, and contributing to process improvements and mentoring.
Biotech
Lead and mentor sponsor‑dedicated site start‑up teams to plan and activate multinational clinical trials. Drive data‑driven forecasting, country‑specific ICF creation, SSU process improvements, site readiness, and escalation/resolution of activation issues to achieve Ready‑to‑Enroll status.
Biotech
Lead eCRF design and specification writing for clinical studies using Medidata RAVE. Design and build RAVE databases, create/edit-check specifications, perform QC, maintain global library objects, support validation, lead client meetings, mentor programmers and data managers, and ensure consistency and compliance across projects.
Biotech
Coordinate and support Phase I clinical trials by maintaining study documents, tracking timelines and milestones, managing CTMS/eTMF, leading meetings, liaising with sites and vendors, supporting start-up and feasibility, mentoring junior staff, and ensuring GCP-compliant, audit-ready execution.
Biotech
Acts as a People Services Center contact handling service inquiries, HR administrative tasks (on/off-boarding, personnel files, offer administration), and data entry into systems (Workday, ServiceNow). Serves as local/regional liaison to managers and employees, supports HR processes, meets service delivery metrics, and provides confidential customer-focused administrative support.
Biotech
Perform site monitoring, initiation and closeout visits to ensure protocol compliance, patient safety, and data integrity. Support feasibility, investigator recruitment, vendor coordination, SAE reporting, and mentor junior staff while adhering to GCP and company SOPs.
Biotech
Perform national site monitoring across the UK for multi‑sponsor clinical trials (oncology focus). Conduct on‑site visits (8+ days/month), apply risk‑based monitoring, and support multiple therapeutic protocols while gaining hands‑on CRO experience and career development.



