Field Clinical Support
To provide clinical and on-site support to the Clinical Department for study start-up and execution of the clinical procedures at research study sites.
- Collaborate with the clinical monitors (Field CRAs), in-house CRA(s), Project Manager(s) during all phases of the study start up process and collect appropriate documentation.
- Support site identification, site qualification and site initiation activities as needed, including but not limited to: letters, reports and communications with physicians and study team members.
- Assist in the development and update of study start up, Physicians Training Plan and materials (didactic, bailouts, etc.) (per product).
- Work closely with the marketing team during the development of the clinical training tools and materials (e.g., animation, procedural steps booklets)
- Train Urologists, Urologic Surgeons, cystoscopy suite/OR staff and ancillary personnel on the use of the investigational products for BPH.
- Work closely with the clinical monitors and study coordinators during the patient screening process, ensuring anatomical criteria are met.
- Provide on-site training and technical support to physicians during procedures, with technical troubleshooting, as needed.
- Collaborate with the clinical team to update trackers/calendars with the scheduling of procedures (ensure good case coverage across clinical sites). Responsible of the assigned region procedure scheduling in collaboration with the clinical sites.
- Collaborate with the physician’s training department management and the clinical team to ensure necessary materials are compiled in preparation of patient review committee for specific clinical trials.
- Work closely with the company’s R&D Engineers to obtain latest product change and identify additional needs for training.
- Completion of case support summary with details of procedural information, specifically associated with product performance and any need to troubleshoot, as applicable. Documentation should take into consideration blinding for blinded study.
- Responsible for compliance with applicable Company Policies and procedures including the clinical protocol (procedural steps per IFU) and study blinding/unblinding plans.
- To assist in obtaining images and data if need for additional information, as needed for study investigation.
- Bachelor’s Degree required but relevant medical / research experience may be substituted.
- RN or relevant health care professional preferred with minimum of 2 years of clinical trial or relevant research experience.
- Minimum of 2 years of clinical trial or relevant research experience.
- Knowledge and ability to produce documents in Microsoft Word, Excel, PowerPoint, internet access and web-based navigation skills.
- Knowledge of EDC, CTMS, and MS project a plus. Working knowledge of regulatory requirements such as ISO 14155, FDA regulations (CFR 11, 50, 54, 56, 812) and ICH Good Clinical Practice (required).
- Maintain timely expense reports
- High attention to detail and accuracy with ability to problem solve independently.
- Candidate should have demonstrated ability to work independently in a remote team setting.
- Strong initiative and positive attitude with clear and concise verbal and writing skills.
- Ability to manage and prioritize multiple tasks and remain focused on project objectives with minimal direction.
- Strong interpersonal communication skills with the ability to effectively communicate across all levels.
- Ability to travel (air, train, car) the US 80% of the time.
- Can direct clinical procedure within the surgery environment
- Can interact with surgeons and staff inside and outside of the surgical environment
- Ability to support study start up activities.