The Clinical Specialist I independently covers SYNC-T therapy cases, training the clinical site team on the safe and effective uses of the investigational product. This person covers SYNC-T cases in the territory, region, or at times the nation, as assigned. Clinical Specialists will provide guidance on the SYNC-T therapy procedure and use of device, thereby enabling physicians and staff to reach expert proficiency. The Clinical Specialist I provides clinical procedure assistance and oversight to physicians and other members of the clinical site team. The Clinical Specialist I will also provide clinical support for investigational site physician and research staff training.
Responsibilities:

The following is not intended to be an all-inclusive list of responsibilities. Other activities may be assigned as required by management.

• Serve as primary resource for clinical support in SYNC-T procedure case coverage.
• Educate clinical site team on the proper clinical usage of investigational product/device by giving presentations and demonstrations using a wide variety of formats and platforms (e.g., slides, transparencies, manuals).
• Attend clinical procedures in the Operating Room, Interventional Radiology Lab, and/or Procedure Room to ensure compliance and successful execution of procedure.
• Train the clinical site team to assist in good patient outcomes and verbally support cases.
• Develop technical acumen to serve as an educational and clinical resource.
• Demonstrate appropriate interactions with all healthcare providers.
• Reconciles inventory/usage as well as missing inventory.
• Assist in the delivery of procedural training with physicians and medical staff.
• Ensure compliance with all applicable regulatory requirements and company policies.
• Respond to clinical site needs and complaints regarding products by developing creative and feasible solutions or working with other related personnel (e.g., clinical operations, medical affairs, product development) to develop optimal solutions.
• Complete site case reports to include narrative summary of each case attended and details on any instances of deviations from the plan.
• Assist internal staff in development of Investigational Plans as required and maintain thorough technical knowledge of study-related products and procedures.
• Assist in creating best practice roadmaps for training of the procedure.
• Provide input to Research and Development regarding product enhancements or new product development ideas learned through physician interactions and clinical observations.
• Work with internal resources and play a role in the creation of training materials for clinical sites and Syncromune personnel that will be interfacing with clinical sites.
• Assist in the recruiting and training of additional Syncromune team members for the field, preparing them for interaction with clinical sites.
• Participate with complaint investigations from the clinical sites to determine root cause and solutions.
• Acquire and maintain current knowledge of perioperative surgical technology practice and hospital and Ambulatory Surgical Center policies and procedures.

REQUIREMENTS

• Associates degree with RT(R) (Radiologic Technologist) or equivalent with clinical experience in interventional imaging, CT and ultrasound.
• Minimum of 5 years in a Clinical Specialist OR related medical role (Rad. Tech. / Surg. Tech., etc.), preferably in a medical device company.
• Prior experience with Surgical Oncology and Interventional Oncology preferred.
• Patient interaction experience within a procedure lab/operating room environment preferred.
• Ability to deliver disease and therapy education to clinical site research teams, in order to ensure study compliance.
• Working knowledge of current regulatory requirements, and best documentation practices related to clinical studies.
• Experience assisting with the creation of presentations of clinical research study information and preparation of training materials for investigational sites, in-house employees and new hires.

KNOWLEDGE/SKILL:

• Strong scientific acumen and ability to grasp complex scientific and technical concepts.
• Familiarity with 21CFR, ISO, ICH, GCP, and relevant regulations, standards, directives, and guidance is essential.
• Excellent analytical and research skills, with a keen eye for detail.
• Exceptional communication, organizational, and problem-solving skills.
• Ability to work independently and collaboratively in a fast-paced, deadline-driven matrix environment.

• Serve as primary resource for clinical support in SYNC-T procedure case coverage.
• Educate clinical site team on the proper clinical usage of investigational product/device by giving presentations and demonstrations using a wide variety of formats and platforms (e.g., slides, transparencies, manuals).
• Attend clinical procedures in the Operating Room, Interventional Radiology Lab, and/or Procedure Room to ensure compliance and successful execution of procedure.
• Train the clinical site team to assist in good patient outcomes and verbally support cases.
• Develop technical acumen to serve as an educational and clinical resource.
• Demonstrate appropriate interactions with all healthcare providers.
• Reconciles inventory/usage as well as missing inventory.
• Assist in the delivery of procedural training with physicians and medical staff.
• Ensure compliance with all applicable regulatory requirements and company policies.
• Respond to clinical site needs and complaints regarding products by developing creative and feasible solutions or working with other related personnel (e.g., clinical operations, medical affairs, product development) to develop optimal solutions.
• Complete site case reports to include narrative summary of each case attended and details on any instances of deviations from the plan.
• Assist internal staff in development of Investigational Plans as required and maintain thorough technical knowledge of study-related products and procedures.
• Assist in creating best practice roadmaps for training of the procedure.
• Provide input to Research and Development regarding product enhancements or new product development ideas learned through physician interactions and clinical observations.
• Work with internal resources and play a role in the creation of training materials for clinical sites and Syncromune personnel that will be interfacing with clinical sites.
• Assist in the recruiting and training of additional Syncromune team members for the field, preparing them for interaction with clinical sites.
• Participate with complaint investigations from the clinical sites to determine root cause and solutions.
• Acquire and maintain current knowledge of perioperative surgical technology practice and hospital and Ambulatory Surgical Center policies and procedures