This new role will be responsible for the execution, and reporting of all clinical trial activities, ensuring adherence to study timelines, budgets, Quality Plans and applicable FDA/ICH/NIH guidelines. The individual in this position will also be responsible for effective management of Clinical Contract Research Organization activities.
- Writes and/or reviews protocols, protocol amendments, informed consent forms, annual reports and regulatory submission documents.
- Participates in interim reporting requirements to DSMBs and NIH.
- Participates in the development of outsourcing strategies, including the selection of CRO’s and other external vendors, and the development of clinical trial budgets.
- Manages clinical study activities at the CRO’s.
- Accountable for ensuring that all studies are carried out according to the study protocol, SOPs, applicable GCP/ICH guidelines.
- Identifies and resolves problems, conflicts and obstacles to the success of projects.
- Participates in clinical operations process improvement initiatives to address clinical needs (e.g., development of investigator database, standardized CRF modules, etc).
- B.S/B.A. degree in a science-related field
- 3-5+ years of clinical research experience, including clinical trial execution and reporting
- Must have experience in Phases 1-3 with international trial experience
- Familiarity with data management, as well as electronic data capture tools and 21CFR11 requirements
- Excellent knowledge of ICH/GCP guidelines
- Strong medical/scientific writing skills
- Experience authoring protocols and clinical sections of clinical documents