Clinical Research Specialist

Mainstay Medical

Mainstay Medical is a medical device company focused on marketing an innovative implantable neurostimulation system, ReActiv8®, for people with disabling chronic mechanical Low Back Pain. The company is headquartered in Dublin, Ireland, with subsidiaries operating in Ireland, the United States, Australia, Germany, and the Netherlands.

The Role:

The position is responsible for the conduct of clinical investigations including, but not limited to, ensuring the clinical investigation is conducted and monitored, and that the data are generated, documented and reported in compliance with clinical investigational plan, and applicable standards and regulatory requirements. As well as establishing and maintaining the relationship with investigators and study sites, this position works closely with the study lead, Director of Clinical Affairs, Research, Product Development, Regulatory Affairs, and Quality to ensure clinical studies are scientifically valid, meet relevant regulatory requirements and are conducted within ethical guidelines.

Position Responsibilities:

• Partners with study leader to development and/or review clinical project deliverables, such as protocols, CRFs, investigator brochure, informed consent, study plans, and other trial related documents
• Manages significant portions of a clinical trial; demonstrates understanding of the study as a whole and the relation of interacting processes to create a well-run study; provide contribution to the overall flow of these processes and create an efficient structure of tools to create a well-run study
• Interacts with clinical investigators, investigational sites, CROs and consultants
• Provides significant contribution to the evaluation of investigators and sites; performs quaification and site activation activities and development of materials; provides training to investigators and site staff; reviews site activation documents for completeness and accuracy before site initiation
• Assists with development of site budgets and site payments
• Monitors clinical sites; performs source verification; assesses study/site issues and implements appropriate solutions; ensures protocol compliance at sites and prepares sites for regulatory inspections and audits; encourages study enrollment; and provides ongoing training and support
• Ensures integrity of data through data review and works with sites to quickly and effectively resolve discrepancies
• Assists with study registration on external sites/databases
• Assists with development and/or review of corrective action plans at individual sites and across trial. May participate in internal/external trial-related audits
• Ensures the study is “audit ready” at all times
• Ensures an adequate supply of clinical devices or study supplies; tracking inventory and collaborating with cross-functional partners
• Serves as liaison with contract monitors or field team members as needed
• Supports the regulatory submission process
• Supports study closure by confirming all regulatory and safety requirements have been met and sending final study closure communications

• Contributes to various process improvement initiatives
• Serves as a resource for inclusion of clinical data in promotional materials for accuracy of clinical content
• May contribute to product development and/or product continuation activities.

Qualifications:

• Bachelors degree and a minimum of 2 years related experience, or an advanced degree without experience, or equivalent work experience.
• Working knowledge and track-record of executing clinical trials.
• Understanding of ISO 14155 standard and FDA regulations for clinical trials
• Proficient computer skills (Microsoft Office, clinical data/management systems)

The salary range for this position is $86,000 to $96,000/year; however, base pay offered will take into account a range of factors, including job-related knowledge, skills, and experience. The total compensation package includes a range of medical, dental, vision, financial, and other benefits, as well as equity.

Mainstay Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to gender, race, color, religious creed, national origin, age, sexual orientation, gender identity, physical or mental disability, and/or protected veteran status. Mainstay Medical participates in E-Verify.