Senior Clinical Research Associate
Reporting to the Vice President, Clinical Operations, the Clinical Research Associate will provide coordination and management support for all Retrotope sponsored clinical trials. Retrotope is focused on identifying an experienced, entrepreneurial and high energy candidate who is looking for the opportunity to work with a highly collaborative team.
- Monitors clinical studies and sites f to ensure compliance with study timelines, study protocols, ICH-GCP and applicable regulatory requirements as well as company SOPs.
- Oversees and is accountable for the adherence to study timelines, study quality, and budget for assigned studies and sites.
- Acts as the primary contact for investigational sites on assigned studies.
- Verifies that all research staff have adequate qualifications and that the staff resource, facilities, investigational product storage, and accountability remain adequate throughout the conduct of the trail
- May perform root cause analysis to help improve the execution of clinical trials (i.e. helping with site activation, subject enrollment, or data cleaning issues)
- Ensures quality of data generated from clinical sites and assists in resolving data quality and protocol deviation issues
- Participate at team meeting, may lead teams and participates in collaborative efforts (e.g. protocol development, CRA selection, etc.)
- Prepares study-related documents including Informed Consent Documents (ICD), source documents, and Case Report Forms (CRF) Completion Guidelines
- Tracks and presents study metrics including site activation, subject screening and enrollment, CRF completion, monitoring status
- Assists in the identification of clinical investigators (CDA processing, feasibility questionnaires)
- Assists in the development of site budgets and facilitates routine site budget negotiations
- Performs activities relating to essential document collection, review, maintenance, and reconciliation ensuring documents from both sponsor and investigational sites follow ICH-GCP guidelines and applicable local regulatory requirements, tracks site readiness. Proficient in the development and review of informed consent form templates to ensure required elements are present
- Manages the overall Investigational Product accountability and reconciliation process for assigned studies
- Participates and collaborates to improve Retrotope’s processes and procedures
- Assists in the organization and conduct of investigator meetings and study training workshops
The tasks and duties listed above are not exhaustive and additional responsibilities may be assigned as needed with little or no prior notice
- A basic understanding of therapeutic indications, ideally rare disease and/or ophthalmology clinical trials
- A clear understanding of the components of study phases and general knowledge of how they apply to clinical development
- Participation in large multi-center and/or global trials
- Working understanding of Good Clinical Practices (GCP)
- Experience working in small companies, or an appreciation of and desire to work in a small company environment
- A team player who will work well with all other functional areas and can effectively interact with individuals at all levels of the organization
- Ability to work under pressure and timeline constraints
- Ability to manage multiple competing priorities, being able to rapidly gather, assimilate and disseminate information on critical project components and milestones, and to translate to internal or external staff assigned to projects
- Detail focus with the ability to manage technical/scientific aspects as well as operational components of logistics, timing and quality
- Bachelor’s degree in Biology, Cell Biology, Molecular Biology, or related field