How will you make an impact? Manages identified Clinical Sites to educate prospective study subjects and health care professionals about clinical trial participation. Takes on added responsibility as requested from VP of Clinical Relations to assist the team in achieving Glaukos clinical enrollment goals. The specific tasks could be: new employee training, planning and leading Glaukos study investigators meetings, planning and implementing scheduled Investigator conference calls, overseeing the creation and delivery of monthly clinical study newsletters, Updating iPad with CRM study tools, performing the functions of CRM while also executing the Surgical Specialist tasks on identified trained Investigators, leading the team with updates with tracking subject software (iMednet), development of tools for scheduling clinical surgery, development of patient out-reach programs, development of surveys to track performance from our customers, attendance as needed to major local, regional, national, international industry meetings, development of surgical forms as needed as technique is developed for new Glaukos products. Being prepared as a back-up to the CRA to deliver the "Excellence in Research" program, Take the lead as directed on developing the system for Glaukos in-office surgery. What will you do?
- Leads clinical recruitment efforts on key US IDE and post-approval trials.
- Acts as an integral member of the core project team working directly with the Clinical Affairs team (Directors or Managers of Clinical Affairs, and Clinical Research Associates) and the Surgical Specialists (Regional Business Managers), and any other relevant team members.
- Develops strong personal relationships with study investigators, clinical coordinators, and glaucoma/cataract key opinion leaders.
- Establishes and builds rapport with clinical sites and assess their recruitment challenges and opportunities.
- Based on a thorough assessment, develops a detailed and specific subject recruitment plan for clinical sites participating in Glaukos-sponsored studies.
- Implements and facilitates subject recruitment and retention activities.
- Analyzes metrics to identify trends, issues, areas of success and for improvement.
- Identifies and proposes strategies, procedures, systems, technology etc. to improve productivity and efficiencies in clinical trial subject recruitment.
- Develops detailed site specific study pre-screening plans based on protocol inclusion/exclusion criteria.
- Performs and oversees patient chart reviews to identify potential study subjects.
- Complies with HIPAA, pertinent federal and state laws and regulations, and relevant Glaukos internal procedures.
- Identifies outreach opportunities to educate patients, health care professionals, advocacy groups, and potential referring physicians about study participation.
- Monitors referral sources to ensure adequate study information is provided to potential participants.
- Identifies, coordinates, and staffs appropriate events and meetings, as needed.
- Proactively and effectively communicates updates on site status to clinical management, Clinical Affairs, and RBMs.
- Communicates trends in the industry and, whenever possible, status of competitive clinical trials.
- Determines best practices for working with sites on increasing subject enrollment.
- Attends major ophthalmic meetings, as needed.
- Provide training to ophthalmology practices on how to properly and efficiently identify patients within their practice who are potential candidates for commercial iStent implantation.
- Employ effective tools and programs to properly communicate the potential benefits of iStent implantation to appropriately identified patients.
How You'll Get there?
- Bachelor's Degree with major in biological science, nursing, or other health-related discipline
- Minimum 9+ years relevant work experience in the medical device or pharmaceutical industry, preferably with experience in ophthalmology and medical devices
- 2+ years' previous people management experience Required
- Knowledge of medical terminology required, with knowledge of ophthalmology terminology strongly preferred
- Prior experience in business development or as a study coordinator or clinical research assistant desirable
- Prior experience developing and executing training plans
- Knowledge of the medical, scientific, design, and clinical research aspect of medical device and/or pharmaceutical trials
- Experience in MS Office (Outlook, Word, Excel); familiarity with databases helpful Required
- Self-motivated and able to work independently, as well as within a team in a multidisciplinary environment
- Must be willing and able to travel a significant amount of time (> 50%)
- Flexibility, as assignments vary in location, time intensity
- COA - Certified Ophthalmic Assistant Preferred COT - Certified Ophthalmic Medical Tech Preferred
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