About the Role
Senior Field Clinical Research Specialist
Location: MA-Boston
JobDescription:
Careers that Change Lives
In this exciting role as the Senior Field Clinical Research Specialist, you will be responsible for clinical trial site management, case coverage, and clinical trial data tracking. This is field based, customer – facing position. You will be the “front line” of Medtronic clinical study conduct at the site level, forming customer relationships that will ensure studies are conducted effectively and efficiently, in accordance with applicable laws and regulations.
Coronary & Renal Denervation therapies are a vital component of the Medtronic interventional cardiology portfolio. In addition to our core products that treat blocked coronary arteries, we are seeking to solve unmet needs in the rapidly growing field of complex percutaneous coronary intervention (PCI). We also are leading the way with the transformational renal denervation therapy, which has the potential to be a powerful tool in battling the global hypertension epidemic.
Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident — we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.
Location: Remote within the U.S.
- Ability to travel up to 75% domestically
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
- Provides field support for various clinical research studies by selecting sites, performing activation duties, setting up protocols, providing training, helping to enroll participants, supporting cases, ensuring quality data acquisition and performing study closure activities.
- Addressing clinical research site needs by maintaining frequent contact via email/phone/on-site visits with principal investigators, sub-investigators, and research coordinators.
- Responsible for gaining and maintaining knowledge of clinical sites in a given geographic area to best understand and assess investigators’ interests and capabilities.
- Provides continuous communication to in-house clinical trial leaders regarding the status and performance of multiple studies.
Other Responsibilities:
- Assist with overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines, and policies.
- Interface with representatives from key functional groups (Monitoring, Data Management, Research & Development, Manufacturing, Sales, Marketing, Regulatory Affairs, Legal, and European Clinical groups).
- Identify and mitigate quality risks and issues for assigned clinical studies, with oversight from study management. Oversee follow-up and resolution of site issues.
- Assist in control of device allocation, distribution and reconciliation.
- Assist with oversight of activities performed by Contract Research Organizations (e.g., CROs, core labs).
- Refer to Standard Operating Procedures (SOPs) and study management process for guidance on everyday study tasks.
- Participate in training to enhance knowledge base.
Must Have: Minimum Requirements
- Bachelor’s degree with 4 years of clinical research/clinical (e.g. field clinical research/clinical specialist/field clinical engineer) experience
OR
- Advanced degree with 2 years of clinical research/clinical (e.g. field clinical research/clinical specialist/field clinical engineer) experience
Nice to Have
- Hospital/clinical experience
- Experience in Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials
- Certification from a Clinical Research Association (CCRP/CCRC)
- Experience at Medtronic or within the medical device industry
- Experience in the management of clinical devices
- Cardiovascular/cardiac rhythm management device training (e.g., pacemakers & defibrillators)
- Experience in a Cath lab, biomedical engineering, hospital/clinic or medical sales
- Experience in clinical studies and/or trial site management/protocols
- Experience collaborating with cross functional clinical partners/customers, physicians and/or medical sales colleagues in the healthcare industry