Field Clinical Specialist

Hart Clinical Consultants (HCC), a full-service MedTech CRO, is seeking Field Clinical Specialist (FCS) support for various projects. The FCS provides technical procedure guidance to the Investigators at clinical trial sites for investigational medical devices while ensuring compliance with the protocol, overall clinical objectives and Good Clinical Practices (GCP). In addition to providing technical support this role requires regular interactions with key stakeholders within the Sponsor and clinical trial sites to support screening, enhance enrollment and provide feedback on cases and/or data collection at the enrollment procedure. Responsibilities Develop, lead and/or facilitate training sessions and in-service education programs in the hospital environment, and may include with principal and sub-investigators, cath lab/O.R. staff, study coordinators, procedure scheduling staff, study sponsor and CRO project leads. Evaluates clinician’s procedural skills, assessing necessary ability, knowledge, and skill to conduct the procedure unaided, or if additional case coverage is needed to ensure the clinical competence of new medical staff members. Attends a protocol-stipulated number of cases for each study’s Investigator, though additional case support may be provided as necessary. Additional site-facing responsibilities may apply depending on Sponsor’s screening and enrollment program. Demonstrate ability to build and sustain credible business relationships with customers and share product expertise accordingly. Verifies that subject meets inclusion/exclusion criteria. Provides expert guidance, per the protocol, the device instructions for use, and investigator’s brochure for any investigational medical devices. May need to be available to investigators and/or site staff for phone support, following initial on-site case support. Prepares, and distributes, per procedure, case support reports, travel reports, study progress updates and relevant project metrics per pre-determined time-frames to the study sponsor and Project Lead. Ensures relevant documentation is properly archived in the Trial Master File (eTMF). Qualifications Recent experience with one of the following catheter-based, medical technology therapeutic areas: Peripheral vascular, coronary vascular, neurovascular, or structural heart Bachelor’s Degree is required, preferably within biological sciences and/or healthcare- related field Experience in the medical device industry is required A minimum of 10 years of clinical background as RN, cath lab tech, etc., working in the field, and/or clinically oriented with cath lab and/or clinical trials experience (Hospital Research Coordinator) or an equivalent combination of education and work experience. A minimum of 8 years of direct experience with expert understanding of clinical research and therapeutic experience in cardiology and/or vascular disease experience at a sponsor or CRO, or an equivalent combination of education and work experience. Ability to travel > 50% (depending on project-specific case schedule) Proficient in Microsoft Office/Windows and Microsoft Outlook. Excellent written and verbal communication skills with ability to work in a global environment Exemplary time management and organizational skills High attention to detail and level of accuracy High degree of tact, judgment, and discretion