Great Opportunity to join a growing team!
Under the direction of the Clinical Operations Director, the In-house Clinical Research Associate III (Senior CRA) is accountable for the day-to-day management of operations of clinical trials commensurate with complexity, including trial start-up, conduct, and close-out activities in accordance with Good Clinical Practices (GCP), Quality Assurance, and other CRO and regulatory requirements.
This Senior CRA will lead Study Team meetings and brief senior management regarding study progress and metrics. The Senior CRA supports the CRA activities at the site and may be assigned to assist with monitoring or co-monitoring activities as well as supporting the management team.
The Senior CRA may be assigned the responsibility of Study Manager or Lead CRA, with guidance, of a Phase I or II study.
- Apply experience and knowledge of research and drug development process
- Ensure compliance, quality assurance, safety and protection of study subjects according to GCP/ICH guidelines, appropriate regulations, and relevant SOPs
- Prioritize compliance to quality management systems, plans and related study management tools and regulations.
- Provide tactical guidance and support to site monitors and site staff to maintain consistency of study standards for all participating investigator sites and stake holders.
- Communicate with clinical sites and the assigned site monitors
- Understand medical and scientific intent of assigned study protocols and train other staff on study procedures, logistics, risks to research Subjects and safety, data evaluation methods etc.
- Manage, lead, and support day-to-day operations of multiple assigned studies to ensure completion per established project team goals and objectives
- May manage overall activities of central laboratories, drug distribution center or other study vendors
- Develop study and site initiation visit preparation materials, ensuring adequate training of study staff and ongoing training for current protocol requirements
- Support clinical quality assurance prior to, during and after sponsor and site audits including corrective actions, remediation and follow up
- Review and provide feedback on study data, query resolution, data scrubbing, etc.
- Organize data and present study metrics to study team, medical monitor or DSMB related bodies