A highly reputable biopharmaceutical corporation is currently hiring a qualified Senior Clinical Research Specialist to work remotely in the United States.
• *POSITION SUMMARY:**
• Highly skilled and experienced
Senior Clinical Trial Specialist (Sr. CTS) will play a critical part in the planning, execution, and oversight of clinical trials across all phases, ensuring adherence to regulatory requirements and industry standards.
• This position provides a unique opportunity to contribute to the development of life-changing therapies in a collaborative, fast-paced environment.
• *KEY RESPONSIBILITIES:**
• *Trial Operations and Support**
• Assist in the tracking and filing of clinical trial protocols and study documents (informed consent forms, CRFs, lab manuals, etc.).
• Manage study Management Team Meeting logistics, Meeting management, agenda creation, minutes and AI capture, tracking and closure.
• Act as a liaison between SMT lead, trial CTMs and cross-functional team members to address assigned tasks and ensure quality and compliant management of work.
• Support Inspection readiness, audits and inspections.
• Support onboarding and offboarding of trial staff internally and externally.
• *Documentation and Compliance**
• Ensure that trial master files (TMF) are maintained and inspection-ready at all times.
• Support data management processes by tracking case report forms (CRFs), query resolution, and database locks.
• Review and ensure accuracy of clinical documentation in accordance with GCP, ICH, and applicable regulations.
• Assist in submission of regulatory documents to IRBs/ECs and Health Authorities as required.
• Assists in coordination of study logistics: clinical supplies, drug shipments, laboratory kits, biological samples.
• Creates and maintains patient enrollment and patient visit trackers/logs.
• Requests confidentiality agreements, study agreements, and clinical site budgets; tracks same documents to their final approval.
• Performs data entry and/or verification into designated clinical tracking systems, including collection of information from designated clinical team members, CROs, vendors, etc.
• *Vendor and Site Management**
• Collaborate with CROs, labs, and other vendors to monitor timelines, performance metrics, and budget adherence as assigned.
• Track and support site management activities such as feasibility assessments, site initiation, and site close-out visits to ensure data is available when needed.
• May manage ancillary/supportive vendor(s) with the oversight of a Clinical Trial Manager
• *Continuous Improvement**
• Identify opportunities for process enhancements and contribute to SOP development and revision.
• *QUALIFICATIONS:**
• *Education**
• Bachelor’s Degree in life sciences, nursing, pharmacy, or related field. Master’s Degree or certifications in clinical research (e.g., ACRP, SOCRA) preferred.
• *Experience**
• 5+ years of experience in clinical research, with at least 2 years in a sponsor or CRO setting.
• Strong understanding of GCP/ICH guidelines and regulatory requirements (FDA, EMA, etc.).
• Experienced supporting multiple studies and working cross-functionally with internal and external stakeholders.
• *Skills**
• Excellent organizational and time management skills.
• Strong written and verbal communication abilities.
• Detail-oriented with a high level of accuracy and problem-solving skills.
• Proficiency in Microsoft Office Suite and electronic data capture (EDC) systems.
• Adaptability in a high change and fast paced environment
• *Preferred Experience**
• Experienced with oncology, rare diseases, or other specialized therapeutic areas.
• Familiarity with global trial operations and multi-country regulatory environments.
• Working knowledge of clinical trial software such as Medidata, Veeva Vault, or similar platforms.