Bachelor's degree in Nursing, Biology, Public Health, or related field; Master's preferred.
6+ years of clinical trial management experience, including 2 years in a leadership role.
Responsibilities
Develop and manage changes to study protocols and tools.
Plan and conduct Investigator Meetings.
Lead monthly webinars and create presentation materials.
Circulate a monthly newsletter to stakeholders.
Develop and track training programs for clinical sites.
Maintain study-wide communications and updates.
Analyze screening failure data for insights.
Create recruitment materials such as brochures and videos.
Conduct site readiness calls and ensure compliance with protocols.
Manage grant finances and submit bi-annual reports to PCORI.
Benefits
Opportunity to lead a significant clinical trial addressing health disparities.
Engagement with a collaborative, multidisciplinary team.
Access to professional development and training resources.
Involvement in innovative research impacting stroke treatment.
Flexible work environment with potential for remote collaboration.
Full Job Description
Job 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.
About Mount Sinai Hospital
Mount Sinai Hospital is a hospital network based in New York City. It was founded in 1852 and is one of the oldest and largest teaching hospitals in the United States. The hospital has been ranked among the top hospitals in the country by U.S. News & World Report and is known for its excellence in patient care, research, and education. Mount Sinai Hospital is affiliated with the Icahn School of Medicine at Mount Sinai and has a staff of over 7,000 physicians, nurses, and other healthcare professionals.
