FSP Clinical Trial Coordinator

Job description

Work Schedule Standard Office Hours (40/wk) Environmental Conditions Office Job Description Join Us as a Clinical Trial Coordinator – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our global team, you’ll have the opportunity to provide administrative and technical support to the Project Team. As a Clinical Trial Coord (CTC), you'll support audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance document. You will provide administrative support for site activation activities and aid in the development of the critical path for site activation within assigned projects to support rapid site activations. Representing CRG personnel, you may utilize local knowledge, organization systems, external site lists, and sponsor directives to develop and review site lists that are suitable for the strategic needs of feasibility activities and to provide local input into the site tiering process. Additionally, you may act as a buddy during the onboarding phase and provide training to new staff as needed. What'll You Do: As a CTC, you will provide operational and administrative support to clinical study teams across multiple clinical trials. This is a highly operational and system-oriented role, requiring regular hands-on use of clinical trial systems and close collaboration with study teams, sites, vendors, and other internal and external stakeholders. Key responsibilities include: Maintain accurate and up-to-date study and participating site information, including site contact details, study status, contracts, documentation, trackers, and reports. Perform hands-on data entry, maintenance, tracking, and reconciliation in clinical trial systems, including Veeva CTMS, eTMF, payment-related systems, study trackers, databases, and other client-specific platforms, ensuring study and site information is complete, accurate, and kept current. Support site payment-related activities, including maintaining and reviewing payment information and trackers, collecting and verifying supporting documentation, following up on payment status, performing reconciliation as applicable, and coordinating with relevant internal teams or external vendors to facilitate timely and accurate site payments. Support the preparation of Investigator Site Files (ISF) and essential study documents prior to Site Initiation Visits (SIV), ensuring required documentation is complete and ready for site initiation. Support site-level EC/IRB reporting activities as applicable, including preparation and tracking of interim/progress reports, safety-related reports, protocol deviation reports, close-out/final reports, and other required site-level documentation, and coordinate submission activities with relevant study team members or vendors. Perform periodic reviews of study documentation and systems, identify missing, incomplete, or inconsistent information, and proactively follow up with the appropriate study team members, sites, or other stakeholders to ensure timely resolution. Support the management of clinical study materials and supplies, including IMP, non-IMP, and other study-related materials, as applicable. Activities may include ordering, distribution, tracking, storage, reconciliation, and coordination of destruction through external vendors. Provide day-to-day operational support to clinical study teams, including preparing and distributing study materials and communications, maintaining study trackers and team information, scheduling meetings, preparing meeting materials, producing meeting minutes, and coordinating study-related logistics and travel arrangements. Support the planning and logistics of Investigator Meetings and other study-related meetings, including meeting coordination and preparation and distribution of presentation, study, and training materials. Maintain study-specific documentation and systems, including study team lists, training records, system access information, activity trackers, and other study-level information as required. Liaise and follow up with study sites, vendors, and internal study team members to obtain required information and documentation and facilitate timely completion of assigned study activities. Proactively identify operational issues, system discrepancies, missing information, and potential risks, and escalate them to the appropriate study team members to facilitate timely resolution and smooth study execution. Maintain knowledge of applicable ICH-GCP, local regulatory requirements, company and client SOPs, written standards, systems, and processes, and complete required training within assigned timelines. Support multiple clinical studies simultaneously, effectively prioritizing activities and adjusting workload based on study timelines, urgency, and business needs. Communicate professionally and effectively with internal and external stakeholders, including study team members, investigators, site staff, vendors, physicians, and other medical or scientific professionals. Perform other study-related operational and administrative activities as assigned in accordance with the agreed role responsibilities and study needs. Education and Experience Requirements High school/secondary school diploma or equivalent with relevant academic or vocational qualifications; Bachelor’s degree in a life science, healthcare, or related field is preferred. Previous experience in clinical research, clinical trial coordination, healthcare, pharmaceutical, CRO, or a related environment is preferred. Entry-level candidates with relevant education and demonstrated interest in clinical research may also be considered. An equivalent combination of education, training, and relevant experience may be considered. Knowledge, Skills and Abilities Strong organizational skills and attention to detail, with the ability to manage multiple tasks and priorities effectively. Ability to work independently while collaborating effectively within cross-functional and study teams. Strong customer focus and a professional approach when working with internal and external stakeholders. Good written and verbal communication skills in English and the local language, as applicable. Strong computer and technical skills, including proficiency in Microsoft Office applications and the ability to quickly learn and effectively use clinical trial systems and client-specific software. Ability to maintain accurate study documentation, trackers, databases, and systems in accordance with applicable procedures and quality standards. Working knowledge of, or ability to develop knowledge of, ICH-GCP, applicable local regulations, SOPs, and clinical trial processes. Ability to identify operational issues, exercise appropriate judgment, and escalate risks or concerns in a timely manner. Ability to adapt to changing priorities and study needs while maintaining quality and meeting required timelines. Self-motivated, proactive, and able to take ownership of assigned responsibilities. Good interpersonal skills and the ability to communicate effectively and professionally with study team members, investigators, medical professionals, vendors, and other stakeholders. Ability to support multiple studies simultaneously and prioritize workload based on business and study needs. Working Conditions and Environment Work is performed in an office and/or home-office environment, with flexibility based on business and study needs. Occasional travel or visits to study-related locations may be required depending on study needs.