Location: Cambridge, MA
Job Code: CTA201903
We are seeking an energetic and self-motivated individual to join our Clinical Operations team. This individual will provide support to ongoing Oncology clinical trials and will report to the Director of Clinical Operations.
Principal Duties and Responsibilities
• Work with clinical operations team in review of clinical documents (Protocols, Informed Consents, study plans and related documents).Participate in study start up activities including preparation and maintenance of study reference manuals, site tools, templates, source documents and guidelines.
• Review site specific Informed Consent forms.
• Support the study specific trial master file by filing and maintain electronic trial master fie (eTMF) for sponsor documents, creating TMF indices/Table of Contents, and maintain audit ready clinical trials documentation.
• Assist with auditing CRO eTMF throughout trial while communicating with CRO team members regarding missing documentation.
• Assist in the collection and review of regulatory documents required for site initiation.
• Track the collection, shipment, and analysis of all study samples and coordinate distribution of clinical trial supplies, equipment, and laboratory kits.
• Compile shipment request to 3rd party laboratory vendors, track and ensure samples received at vendors, follow up with sites/CRO for missing samples, and prepare/provide summary reports to clinical trial manager as requested.
• Verify and track invoices and payments for vendors and sites.
• Liaise with clinical drug supply to ensure adequate study drug inventory, facilitate site storage solutions and issue resolution.
• Collaborate with CROs, vendors and clinical sites in performing the day-to-day activities of a clinical trial, including generating management status reports, sample and drug supply tracking.
• Attend study team and department meetings while assisting with meeting logistics (scheduling, room and equipment set up, attendance tracking), agenda preparation, draft meeting minutes, and collating materials for meetings.
• Develop an understanding of clinical trial research through exposure to research protocols, the drug development process, clinical meetings, Company Standard Operating Procedures (SOPs), and Food and Drug Administration (FDA) guidelines as related to Good Clinical Practices (GCP).
• Bachelors Degree Required.
• 1-2 years of experience working in academic study center, pharmaceutical/biotechnology or CRO organization.
• Proficient in computer technology used in an office environment (Microsoft Word, Excel, and PowerPoint).
About H3 Biomedicine Inc.
H3 Biomedicine Inc. is a privately-held, uniquely-structured oncology discovery enterprise whose sole mission is to become a prolific source of new drugs that treat more human cancers with greater success. H3 Biomedicine is applying the expertise of leading scientists to the integration of insights from cancer genomics with innovative capabilities in synthetic chemistry and tumor biology to pursue the most promising current opportunity in cancer therapeutics: patient-based, genomics-driven, small molecule drugs.Submit Your Résumé