Clinical Trials Specialist
Company Overview
MedRhythms is a digital therapeutics company committed to revolutionizing healthcare for people living with neurologic disease and injury. Our mission is to help patients walk confidently again, by expanding access to patient-centered, world-class therapy.
Our groundbreaking technology uses sensors and immersive music to deliver evidence-based treatments to improve walking. At its core is a cutting-edge treatment mechanism based on the latest neuroscience research in music: rhythm can be used clinically to directly target the human motor system and improve functional outcomes in walking. It's our mission to see these outcomes realized for the millions of people worldwide who struggle with walking impairments.
MedRhythms has a pipeline of innovative therapies in neurology, including Stroke, Parkinson’s Disease, and Multiple Sclerosis. Our flagship product for chronic stroke received Breakthrough Device designation from the FDA, and we’ve launched clinical trials with leading research institutions across the U.S., including Johns Hopkins, Mount Sinai, Cleveland Clinic, and Spaulding Rehabilitation.
Cultural Pillars that drive us and our success:
We are committed to People First
We are committed to Excellence Always
We are committed to being Action Focused
We are building a workforce that consists of hybrid team members living and working in and around our Portland, Maine headquarters and remote individuals located in Massachusetts, New Hampshire, Vermont, New Jersey, New York, Pennsylvania, Florida, Illinois and California. We do ask all of our team members to visit our headquarters throughout the year to get to know our team and fully integrate with our culture! If you are located in an area that is not listed, don't let that stop you from applying. We would still be interested in speaking with you!
Position Overview
MedRhythms is seeking a clinical trials professional who will report to the Head of Clinical Trials to support the day-to-day operations of device studies with partnered industry and academic leaders in neurologic disorders and physical medicine and rehabilitation. Incumbent would be responsible for activities such as: performing investigative site recruitment/feasibility, site project training, remote clinical data monitoring and resolution, site progress status tracking, documentation filing, and other duties. Additional responsibilities would include essential document collection and review for site start up and initiation in compliance with project specifications and applicable SOPs with adherence to FDA Regulations, ICH/GCP guidelines and good documentation practices.
Qualified candidates should have direct experience in the application of GCP, demonstrated time management skills with the ability to prioritize multiple competing tasks, strong written and oral communication skills, and excellent attention to detail. Candidates should be a self-motivated, results-driven team member who enjoys collaborating with others. Travel will be required for this position during study initiation activities, and as necessitated by ongoing projects. Role could require up to 70% of travel at times, but will be 5-20% of the time on average.
Compensation will be commensurate with experience and is a combination of salary and bonus potential.
Responsibilities
- Responsible for study start-up and study conduct activities including ICF review, developing study specific templates, standard operating procedures, work instructions. and TMF plan.
- Coordinate the development and dissemination of essential study documents, including study protocols, training materials, IRB submission documents, data collection forms, and other related documentation.
- Perform device demonstrations and training for external study teams.
- Track and manage the progress of assigned clinical study metrics and other project related information, e.g., timelines, enrollment, and key milestones.
- Communicate study progress and activities, and drive resolution of issues encountered with sites during all phases of the study.
- Monitor study data for trends, errors, and compliance to the protocol, standards and regulations. Additionally, will assist with data preparation for study analyses, publications, and presentations. Interact with CROs, vendors, investigators, monitors and other external partners to provide information and resolution for specific requests and issues.
- Manage and track clinical and non-clinical study supplies.
- Provide administrative support in other areas of clinical research operations as they arise, including storage of all pertinent study correspondence and essential documents, adverse event reporting, clinicaltrials.gov registration, preparation of study reports (interim, final, etc.) and presentations, etc.
- Manage and oversee the coordination of site close-out activities (monitoring, reconcile/archive TMF, device accountability, vendor financials, update clinicaltrials.gov, etc.)Identify, escalate, and mitigate risks to study and timelines as appropriate.
- Travel will be necessary for site initiation/training, investigator meetings, external vendor meetings, etc. International travel may be necessary based upon business needs.
- Assist with other duties as assigned.
We’re looking for you to bring
- Bachelor’s degree
- 2+ years of academic or industry-sponsored clinical research experience
- Thorough knowledge of ICH guidelines and FDA regulations relevant to clinical studies
- Comprehension of medical terminology and peer-reviewed scientific literature relevant to physical medicine and rehabilitation
- Excellent verbal and written communication skills
- Excellent problem solving and critical thinking skills
- Ability to interact professionally with all organizational levels
- Ability to manage competing priorities in a fast paced environment
- Must be able to work in a team environment, including inter-departmental teams
What we can offer you
- Meaningful, purpose driven work on a life-changing product
- Collaborative, supportive, smart and fun team
- Competitive compensation and benefits: Medical, dental, vision, disability, stock options, bonus potential, paid parental leave
- Generous paid time off: Unlimited vacation, sick and volunteer time off
- Flexible hybrid work environment: Work where and when you are most productive
- Downtown Portland, Maine office: Inviting office in the heart of the Old Port