Key Responsibilities
Study Coordination & Administration
Create, maintain, and update study information within CTMS and GoClinical, including sponsor, study, site, contact, subject, visit, issue tracking, and study-related data.
Support study start-up, maintenance, and closeout activities across assigned projects.
Complete site setup activities, including DCV introductions, onboarding, and training.
Assist with study closeout activities, including reconciliation of returned equipment and final system reconciliations.
Maintain accurate study documentation and ensure records are current and audit-ready.
Research Visit Coordination
Coordinate and manage research visit scheduling across study participants, sites, healthcare professionals, and project teams.
Act as a central point of contact for visit planning and logistics.
Ensure timely coordination of decentralized and hybrid study visits through effective communication with all stakeholders.
Monitor visit completion and proactively resolve scheduling conflicts or operational challenges.
Support visit-related documentation, tracking, and reporting requirements.
Stakeholder Communication
Serve as the primary point of contact for day-to-day site communications, document submissions, and activity coordination.
Establish and maintain strong working relationships with Sponsors, CROs, clinical sites, central laboratories, and internal teams.
Coordinate and facilitate communication between stakeholders to ensure timely delivery of study activities.
Attend and document key meetings, including Kick-Off Meetings (KOMs), internal handovers, vendor calls, and sponsor teleconferences.
Operational & Logistics Support
Coordinate decentralized visit activities, including scheduling, courier bookings, sample collection, shipment, and delivery logistics.
Manage inventory oversight and tracking of study-related equipment and materials.
Support shipping logistics and maintain accurate records within CTMS and GoClinical.
Track and report study metrics and operational performance indicators as directed by the GCPM.
Documentation & Quality Management
Receive, review, track, manage, and distribute source documentation from decentralized visits.
Support the creation, review, and maintenance of study documentation and training materials.
Participate in CTMS and GoClinical audits and quality reviews as directed by the GCPM.
Ensure compliance with applicable SOPs, ICH-GCP guidelines, study protocols, and regulatory requirements.
Additional Responsibilities
Support continuous improvement initiatives across clinical operations.
Perform other duties as assigned to support business and project needs.
Required Skills & Competencies
Working knowledge of ICH-GCP and applicable clinical research regulations and guidelines.
Understanding of clinical trial processes and decentralized clinical trial operations.
Professional, confident, and articulate communication style.
Advanced computer literacy, including Microsoft Office (Word, Excel, PowerPoint, Outlook) and Adobe Acrobat.
Experience working with CTMS, study management systems, or clinical databases
Bachelor's degree in Life Sciences, Healthcare, Business Administration, or a related field; or
Equivalent combination of education, training, and experience, including a minimum of three years' relevant experience demonstrating the knowledge and skills required to perform the role successfully.
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We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.
Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.
ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
