The posting
Description
The Neurology department is seeking a Clinical Research Project Manager for the PCOR-funded Treatment with Endovascular Intervention for STroke Patients with Existing Disability (TESTED) clinical trial.
TESTED is a unique, PCORI-funded comparative effectiveness, observational, multicenter study that aims to evaluate the effectiveness of endovascular acute stroke treatment among patients who have a pre-existing disability. The trial is posed to addressed significant disparities in care of devastating acute ischemic stroke. As the Prime Project Manager of, the candidate will oversee several aspects of national project management for this unique clinical trial. The project manager will work directly with performance sites in the clinical trial. The appropriate candidate should have a clinical background and extensive clinical research experience.
Responsibilities
- Develop/Manage changes to protocol, ICD, MOP, CRFs, study tools.
- Planning Investigator Meetings.
- Help lead and make slides for monthly Webinars.
- Develop and circulate monthly newsletter.
- Develop and track Training for sites.
- Lead and maintain study wide communications.
- Screen failure data analysis.
- Develop recruitment materials (Brochure/video).
- Conduct and schedule site readiness calls.
- Grant management including being involved in overall grant finances.
- Bi-annual report submission to PCORI.
- Answer Clinical and protocol questions.
- Ensure Protocol compliance.
- Clinicaltrials.gov maintenance.
- Develop novel strategies for creating study enthusiasm and site engagement.
- Communicate with sites regarding key study updates during study webinars and other avenues.
- Maintain communication with PCORI.
- Lead the clinical project team and various study team meetings.
- Fully involved in resolving issues; take part in procedure improvement initiatives.
- Attain clinical study goals by working with other members of the study team to outline their priorities, and to also resolve conflicts that may come up in the project process.
- Work hand-in-hand with the study team to manage documents that are related to the clinical study.
- Responsible for maintaining the protocol versions and manual of procedures for the trial.
- Help prepare safety reports in collaboration with clinical leaders of the project and sites.
- Work collaboratively with team members to ensure regulatory compliance.
- Perform related duties based on departmental need.
Qualifications
- Bachelor's degree in Nursing, Biology, and Public Health or related scientific/health field, Masters preferred.
- 6+ years of experience managing clinical trials, including 2 years in a management/leadership role.
Additional Preferred Skills Considered
- Possess excellent communication skills so as to be able to effectively convey messages across to both study team members and other external people like vendors and external consultants.
- Good problem-solving, organizational, and leadership skills are highly required.
- Ability to work with little or no supervision.
- Ability to pay keen attention to detail at all times.
- Must be able to work within stipulated timeframes or deadlines even in the face of multiple responsibilities or projects.
- Must be able to work as part of a team or in most cases lead a team.
- Must have a ‘one of a kind’ work ethic, and must exhibit a great level of self-discipline.
- Ability to organize and motivate other members of the study team.
- Proficient user of basic computer applications for the execution of daily project operations.
- Experience in writing clinical study procedures and other clinical documents is a plus.
- Experience in an academic or clinical setting in the area of clinical specialization.
- SoCRA and/or ACRP certification.
Employer Description
Strength through Unity and Inclusion
The Mount Sinai Health System is committed to fostering an environment where everyone can contribute to excellence. We share a common dedication to delivering outstanding patient care. When you join us, you become part of Mount Sinai’s unparalleled legacy of achievement, education, and innovation as we work together to transform healthcare. We encourage all team members to actively participate in creating a culture that ensures fair access to opportunities, promotes inclusive practices, and supports the success of every individual.
At Mount Sinai, our leaders are committed to fostering a workplace where all employees feel valued, respected, and empowered to grow. We strive to create an environment where collaboration, fairness, and continuous learning drive positive change, improving the well-being of our staff, patients, and organization. Our leaders are expected to challenge outdated practices, promote a culture of respect, and work toward meaningful improvements that enhance patient care and workplace experiences. We are dedicated to building a supportive and welcoming environment where everyone has the opportunity to thrive and advance professionally. Explore this opportunity and be part of the next chapter in our history.
About the Mount Sinai Health System:
Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 48,000 employees working across eight hospitals, more than 400 outpatient practices, more than 300 labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time — discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it. Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients’ medical and emotional needs at the center of all treatment. The Health System includes more than 9,000 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. We are consistently ranked by U.S. News & World Report's Best Hospitals, receiving high "Honor Roll" status, and are highly ranked: No. 1 in Geriatrics, top 5 in Cardiology/Heart Surgery, and top 20 in Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 12 in Ophthalmology. U.S. News & World Report’s “Best Children’s Hospitals” ranks Mount Sinai Kravis Children's Hospital among the country’s best in several pediatric specialties. The Icahn School of Medicine at Mount Sinai is ranked No. 11 nationwide in National Institutes of Health funding and in the 99th percentile in research dollars per investigator according to the Association of American Medical Colleges. Newsweek’s “The World’s Best Smart Hospitals” ranks The Mount Sinai Hospital as No. 1 in New York and in the top five globally, and Mount Sinai Morningside in the top 20 globally.
Equal Opportunity Employer
The Mount Sinai Health System is an equal opportunity employer, complying with all applicable federal civil rights laws. We do not discriminate, exclude, or treat individuals differently based on race, color, national origin, age, religion, disability, sex, sexual orientation, gender, veteran status, or any other characteristic protected by law. We are deeply committed to fostering an environment where all faculty, staff, students, trainees, patients, visitors, and the communities we serve feel respected and supported. Our goal is to create a healthcare and learning institution that actively works to remove barriers, address challenges, and promote fairness in all aspects of our organization.
Compensation
The Mount Sinai Health System (MSHS) provides salary ranges that comply with the New York City Law on Salary Transparency in Job Advertisements. The salary range for the role is $104995 - $157492 Annually. Actual salaries depend on a variety of factors, including experience, education, and operational need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.
