Field Clinical Specialist Jobs

About The Position

Requirements

• Completion of an undergraduate degree (e.g. Life Science, Nursing, Medicine, Biomedical Engineering, etc.) is required.
• A minimum of 8+ years of related job experience is required for this position.
• At least 5+ years of relevant experience within medical devices, surgery, and operating room support.
• At least 5+ years of field monitoring and site management performing pre-study visits, initiation, interim, and close out visits.
• Demonstrated working knowledge of ICH-GCP and FDA regulations.
• Must have experience working with patients preferably in a clinical environment.
• Proficient with MS Office and electronic databases (e.g., CTMS, IRT, eTMF).
• Ability to collaborate with all levels of management in a cross-functional team environment is required.
• Love to travel to support customer and study meetings is a must (up to 60%); for domestic, trans-border and international.

Nice To Haves

• Clinical Research Certification is an asset.
• Registered Nurse (RN certification) is a strong asset.
• Strong written and oral communication skills and experience mentoring/coaching and providing training is preferred.

Responsibilities

• Responsible for the successful execution of clinical trials by supporting site management and monitoring activities.
• Ensure assigned clinical studies comply with regulatory standards and protocols by conducting site visits, verifying data accuracy, and safeguarding patient rights.
• Typically works on studies with moderate to high complexity (in terms of design, location, regulatory requirements, etc.).
• Proactively identifies and resolves clinical site issues and participates in process improvement initiatives as required.
• Contributes to the development of clinical development plans, and other company initiatives as required.
• May be requested to support field-based clinical support by providing information and training to customers in the use of specific products in a clinical setting (e.g., operating room, outpatient clinic, etc.).
• Responsible for site management and monitoring of assigned clinical study(ies).
• Collaborate with Study Management and other clinical operations staff to perform site management and field monitoring activities.
• Establish and maintain excellent working relationships with external stakeholders such as Investigators, Study Coordinators and other site staff; and internal stakeholders to meet recruitment targets and to deliver high-quality data on time.
• Ensure that all Adverse Events (AE), Serious Adverse Events (SAEs) and Product Quality Complaints are reported within the required reporting timelines and documented as appropriate.
• Maintain and update trial management systems.
• Perform field monitoring independently, including but not limited to qualifying site assessments, and initiation, interim and closeout visits.
• Complete monitoring reports, follow-up letters etc. ensuring compliance to company SOPs and timelines.
• Data monitoring activities, including on-site and remote review of study data for accuracy, integrity, and completeness.
• Build a collaborative partnership with CRAs and support as needed.
• Assist the study team in planning clinical supplies and in particular, the Investigational Product. Ensuring that the product is available for the sites to support study enrollment.
• Provide site training (Protocol, Amendment, GCP, etc.), as required.
• Support the collection of essential documents and the maintenance of the TMF, as required.
• Serves as the primary resource for clinical support in the areas of patient selection, basic troubleshooting, device utilization, and patient follow-up for company products.
• Provide on-site clinical, technical, and educational support, guiding medical staff through use of commercially available medical devices, and troubleshooting products in operating rooms or other medical facilities.
• Provides external staff training, and other product-related specifications, as requested.
• Maintains a working knowledge of Company products, competitive devices, and new or competitive techniques used in surgery.
• Performs other related duties as qualifications and training allows.

Benefits

• work-life balance
• competitive package
• internal mobility