Note: The job is a remote job and is open to candidates in USA. The Institute for Neurodegenerative Disorders (IND) is a nonprofit research institute focused on advancing diagnostic tools and developing new treatments for neurodegenerative conditions. The Clinical Research Specialist II will support clinical research programs, collaborating with research professionals and managing site activities to ensure successful study execution.
Responsibilities
- Serves as the primary point of contact for U.S.-based clinical and imaging site activities including, site activations, site training and site compliance related to clinical data, regulatory documentation, recruitment goals, and sponsor requirements
- Serves as the liaison with Central Institutional Review Board (CIRB), as well as local site IRBs as applicable
- Assists with and may lead monitoring site performance and compliance, including remote monitoring activities; conducts site visits, as needed
- Conducts initial and ongoing collection of study and site regulatory documents; maintains documentation within the electronic Trial Master File (eTMF)
- Cultivates strong relationships with collaborators and stakeholders across the study ecosystem, including study leadership, study core staff, and study sponsors
- Provides support to the Principal Investigator (PI) and other IND Site Management as needed, including scheduling meetings and teleconferences, developing agendas and meeting materials, coordinating meeting/call speakers and preparatory materials, circulating meeting minutes, and proactively tracking status of action items through completion
- Supports oversight of U.S. clinical and imaging sites, including proactive coordination with site teams to address operational, and regulatory, considerations that impact study execution
- Facilitates communication with participating site to ensure alignment with study protocols, IND policies, and applicable U.S. regulatory requirements
Skills
- Bachelors' with 3-5 years applicable experience, or Masters' with relevant internship experience
- Experience working within clinical research fields and within a matrix environment, complex initiatives involving human subject research and related federal regulatory regulations
- Working knowledge of clinical research regulatory frameworks including Good Clinical Practice (GCP), Institutional Review Board (IRB) processes, and federal human subjects research regulations (e.g. FDA, OHRP)
- Demonstrated problem-solving and critical thinking skills, as well as ability to develop processes where there is no existing roadmap
- Excellent communication skills, both verbal and written; experience with PowerPoint and making presentations
Benefits
- Bonus eligible
- Medical, dental, and vision Insurance
- Flexible Spending Accounts (FSA)
- Employer-paid life and disability insurance
- Paid time off: Flexible vacation, sick and holidays
- Contribution to retirement plan (403b)
- Professional development opportunities
- 100% remote work with opportunities for in-person company events
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