Gibsonia, Pennsylvania
Pittsburgh, Pennsylvania
Pittsburgh, Pennsylvania
Posted: 18-May-23
Location: Pittsburgh, Pennsylvania
Type: Contract
Categories:
Required Education:
The Clinical Research Associate will work closely with R&D and the commercialization team to plan, conduct, and document clinical studies inside and outside the US.
The ideal candidate will have experience conducting medical device clinical studies and a proven track record of completed studies. They should have strong communication and project management skills, as well as knowledge of both US and EU regulatory landscapes. This role will interface with R&D, quality/regulatory, and commercialization team members and report to the Director of R&D. The successful individual will be adaptable and energized by a dynamic startup environment as a key member of our team working to improve surgical outcomes within the cochlear implant space.
Job Responsibilities:
- Responsible for the execution of clinical research in alignment with strategic objectives of the company and in compliance with applicable policies, procedures, standards, and regulations.
- Support and manage projects pertaining to clinical research including generation and reporting of timelines, milestones, project plans/deliverables, budget and resource allocations.
- Establish and optimize operating policies and procedures to manage clinical research efficiently and effectively.
- Collaboratively work with cross functional teams to enable successful product launches for both pre-clinical, clinical and commercialization phases.
- Directly or indirectly supervise clinical research staff, including consultants and third parties. Build strong, trusting, and cooperative relationships with others across the entire project.
- Lead and support site qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol. Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff.
- On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) to identify site deviations/deficiencies and corrective/preventive actions to mitigate risk.
- Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.
- Regular travel for business objectives is required, including international. Travel requirement up to 50%.
Requirements:
- BS in Life Sciences, Engineering, or related field.
- 5+ years of clinical research experience, ENT or Neurosurgical medical device clinical research preferred.
- Knowledge of FDA regulations, ISO 13485, GCP/GMP, and other global requirements related to clinical research.
- Experience supporting FDA submissions preferred (i.e. IDE, PMA, 510(k), De Novo).
- Experience managing clinical research reporting, such as reporting to regulatory authorities and clinical research oversight entities (IRB or Ethics Committee).
- Extensive knowledge of clinical study operations, study design and governing regulations.
- Experience with software tools for clinical research including electronic data capture and electronic database development and utilization.
- Project management experience and fluency with related tools.
- Proficient knowledge and demonstrated ability using MS Office Suite.
