Clinical Research/Trials Coordinatoor

We are a fast growing Medical Device Company with an immediate job opening for a Clinical Research/Trials Coordinator.  NeuroWave is hardworking but informal employer, offering strong salary and benefits, tuition reimbursement, and outstanding growth opportunity. This position will require a detail oriented self starter with strong interpersonal skills, and positive and motivated attitude.

Duties and Responsibilities:

• Coordinates Clinical Trial(s) within Good Clinical Practices framework.
• Clinical Study Liaison between sponsor and Clinical Site.
• Clinical Trial document creation, collection and review within regulatory framework including Study Protocols and Informed Consents.
• Coordinates IRB functions and documentation.
• Plans and manages Clinical Trial(s) to meet the project related timelines and contractual obligations. Provides status update reports.
• Provides technical assistance to Clinical Site(s) related to NeuroWave’s products/projects.
• Responsible for accurate, timely and complete data collection, including on-site, hands-on data collection from patients using NeuroWave’s neurophysiological monitors.
• Participates in the analysis and interpretation of clinical data.
• Monitors/audits Clinical Site(s) for study compliance according to regulatory requirements.
• Maintains data and/or databases for ongoing clinical studies.
• Reports and obtains approvals for any protocol changes or deviations.
• Identifies and reports unanticipated adverse effects to Regulatory personnel. Responsible for accurate, complete and timely data submissions.
• Primary clinical resource for regulatory submissions and project team.
• Authors or co-authors scientific manuscripts on related trials.
• Deals with Human Subject issues for NIH & DOD grant submissions.
• May supervise other clinical personnel.
  

Required Qualifications:

• Education: 4-year degree preferably in biomedical engineering. M.S. is desired.
• Previous clinical trials experience, preferably as a Clinical Research Coordinator.
• 3+ years related experience in medical device or drug IDE studies, or equivalent.
• Basic knowledge of regulatory framework concerning clinical trials, including IDE, 510(k) or equivalent and GCP procedures.
• Ability to work in a fast paced environment and successfully manage a full workload across multiple-projects
• Ability and/or experience in physician/patient contact.
• Excellent communication and interpersonal skills with ability to maintain ongoing communications with clinical study site personnel, patients, and colleagues.
• Ability to understand and maintain confidentiality.
• Organized with excellent oral and written communication skills.
• Comprehensive knowledge of relevant software: Windows, Word, Excel, Outlook and Access.
• Knowledge of using MATLAB is a plus.

Please email your cover letter and resume (with salary requirements) to skrstic@neurowavesystems.com.