Arthrosi Therapeutics is a clinical stage company that is looking to expand their Clinical Operations Team. The full-time Senior Clinical Research Associate will be an integral member of the Clinical Operations team whose work drives the company to meet critical milestones in the Arthrosi clinical development programs. The successful candidate will be self-motivated, comfortable working in a start-up environment where everyone pitches in to realize company goals, flexible, and innovative. Must have experience managing Phase I – III trials, knowledge of clinical operations, ICH/GCP and FDA regulatory requirements.
Hybrid work model with flexibility to work remotely and regularly attend in-person meetings in San Diego, CA.
- Assisting the Sr. CTM in managing and/or leading the day-to-day operations of assigned study execution tasks to support meeting project team goals and objectives
- CRA will work closely with a cross-functional team in a fast-paced high growth environment to ensure that clinical trials are conducted on time and within budget, and in accordance with applicable GCP/ICH guidelines, other regulatory requirements, and Arthrosi SOPs.
- Assist with the identification, evaluation, selection, and oversight of clinical trial sites and vendors.
- Partner efficiently, effectively, and professionally with participating study sites and vendors to ensure smooth study conduct.
- Provide study progress updates to Sr. CTM/CTM and other stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues
- Provide oversight support in the timely recruitment of trial participants with subsequent efficient and effective data management.
- Provide monitoring oversight through review of monitoring schedules, metrics, and reports
- Participate in study monitoring visits, including CRA oversight visits
- Management and oversight of selected study vendors; ensuring all vendors meet the predetermined program milestones according to budget and timeline.
- Support the development of study documents and tools, including study protocols, consent forms, project plans budgets, logs, templates, newsletters, and other documents, as needed.
- Implementation, review, and oversight of Trial Master File for inspection readiness.
- Recommend and implement innovative processes to improve and impact clinical trial management and deliverables including contingency plans.
- Coordinate and conduct data reviews and data cleaning activities
- Review clinical study plans, reports, and study metrics
- Participate in study feasibility assessments and selection of countries and sites for study conduct
- Participate in creation and conduct of study-specific training at investigator meetings, CRA training, and other meetings/trainings, as appropriate
- Tracking of ancillary and investigational supplies, specimens and/or imaging.
- Ensure compliance with ICH/GCP and global regulatory guidelines.
- Must be willing to travel periodically within the United States and internationally.
- Bachelor’s degree (or equivalent) in a relevant scientific field preferred.
- Minimum of 3-6 years of clinical trial experience including vendor management experience (e.g., imaging, central lab, IRT) and clinical monitoring in pharmaceutical, biotech or CRO setting.
- Experience in Phase I-III clinical trials, including global experience.
- Thorough knowledge of drug development, clinical operation processes and procedures according to ICH/GCP and other regulatory guidelines.
- Proficiency with MS Office products Word, Excel, SharePoint, PowerPoint.
- Able to recognize need(s), find solutions, and take initiative to address in pro-active manner.
- Strong organizational, time management, skills.
- Excellent communication skills, both oral and written.
- Strong collaborator with demonstrated record of success in a cross-functional team and fast-moving environment.