Description
The Clinical Research Manager - Licensed provides clinical support and administrative direction for the Department of Medicine Clinical Trials Office (MCTO). In collaboration with the MCTO Medical Director, clinical trials investigators, and MCTO Administration, this candidate is responsible for the implementation and conduct of clinical trials with investigational agents in the Department of Medicine. The candidate must have a knowledge of treatment modalities in medicine and the process of conducting clinical research. The candidate will follow a caseload of patients in the ambulatory setting and assist in the administration and plan of the research program.
This role reports to the MCTO's Director for research responsibilities and the MCTO Nurse Practitioner for clinical responsibilities.
Responsibilities
Administrative Duties
- Supervise Clinical Research Coordinator positions and other Clinical Research Nurses to ensure protocol compliance, accurate data collection and sample acquisition
- Develop educational programs for the Nursing staff regarding specific protocols
- Manage clinical trials portfolio and assure timely regulatory start up of protocols
- Monitor accruals and identify opportunities to grow research programs
- Liaison with industry sponsors and Clinical Research Organizations
- Liaison with MCTO office (including pre and post award)
- Ability to motivate, develop and coach individuals
- Manages human resources, inclusive of recruitment, hiring, evaluation, retention, progressive discipline and termination
Clinical Research Duties
- Develop and implement ongoing quality improvement activities. Ensure safe, efficient and quality research patient care by following the medical center's policies and protocols
- Responsible for coordinating study enrollment, establishing a database of patients, protocol treatment and follow up care for patients participating in clinical trials
- Collaborates with primary care nursing staff to provide nursing care to patients receiving therapy on a clinical research trial
- Assist the principal investigator in the process of assuring adequate informed consent
- Assure the primary nursing staff understands how to administer investigational agents per specifications of the protocol
- Administration of investigational agents when necessitated
- Assure that blood sampling and specimen preparation is accomplished per specifications of the protocol and monitors test results, as appropriate documents clinical study and therapy in the patient charts and all other databases as required
- In collaboration with the nursing staff, assess patients on study for complications related to therapy
- Communication of observations/findings to attending physicians and in medical records is required
- Ensure that drug dosing and sample collections times are recorded on study source documentation
- Provide in-service training and services as a resource to other clinical personnel including physicians, nurses, pharmacists and other allied healthcare professionals
- ID preparation. documentation and reporting when required
- Communicate with referring and affiliated physicians to ensure documentation of clinical findings throughout the clinical trial
- Collaborate with attending physicians to identify and recruit patients eligible for clinical trials
- Establish and maintain database of prospective patients for clinical trials with the Clinical Trials Management System
- Oversee scheduling of patient laboratory and radiologic assessments, admissions and clinic visits
- Establish mechanism to ensure complete and accurate data collection and documentation
Clinical Duties
- Assure compliance with mandated clinical interventions inclusive of core measures within the department and the Medical Center. Interface directly with Mount Sinai Medical Center departments, Administrators, Nursing, Medical and Quality Leadership, and Clinical staff. Oversees administrative and daily operations of the core measures and clinical intervention compliance program.
- Coordinate core measures and clinical intervention compliance activities with Nursing, Medical and Quality Leadership
- Assist in the development and design of action plans to support compliance with measures indicators and provide support and educational resources to departments and services relative to core measures quality assessment and improvement processes.
- Assist in establishing and implementing short and long term goals, objectives, policies, and operation procedures for core measures programs
- Provide coordinator and leadership in the execution of day to day program activities, as appropriate to program objectives and areas of expertise
- Oversee the collection, compilation and analysis of clinical program activity data
- Provide technical assistance, resource services, consultation and education to clinical departments relative to core measure activities
Qualifications
- Bachelor's degree in Nursing (BSN) OR Bachelor's degree and Certified Physician Assistant
- NYS License with current BLS and ACLS certifications
- Progressive managerial and clinical job related experience specific to areas of responsibilities
- 5 years’ experience in a hospital/medical environment including1 year supervisory
- 1 year of research experience preferred
Employer Description
Strength Through Diversity
The Mount Sinai Health System believes that diversity, equity, and inclusion are key drivers for excellence. We share a common devotion to delivering exceptional patient care. When you join us, you become a part of Mount Sinai’s unrivaled record of achievement, education, and advancement as we revolutionize medicine together. We invite you to participate actively as a part of the Mount Sinai Health System team by:
- Using a lens of equity in all aspects of patient care delivery, education, and research to promote policies and practices to allow opportunities for all to thrive and reach their potential.
- Serving as a role model confronting racist, sexist, or other inappropriate actions by speaking up, challenging exclusionary organizational practices, and standing side-by-side in support of colleagues who experience discrimination.
- Inspiring and fostering an environment of anti-racist behaviors among and between departments and co-workers.
At Mount Sinai, our leaders strive to learn, empower others, and embrace change to further advance equity and improve the well-being of staff, patients, and the organization. We expect our leaders to embrace anti-racism, create a collaborative and respectful environment, and constructively disrupt the status quo to improve the system and enhance care for our patients. We work hard to create an inclusive, welcoming and nurturing work environment where all feel they are valued, belong and are able to advance professionally.
Explore more about this opportunity and how you can help us write a new 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 43,000 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 approximately 7,400 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 and top 20 in Cardiology/Heart Surgery, 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. 14 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.
The Mount Sinai Health System is an equal opportunity employer. We comply with applicable Federal civil rights laws and does not discriminate, exclude, or treat people differently on the basis of race, color, national origin, age, religion, disability, sex, sexual orientation, gender identity, or gender expression. We are passionately committed to addressing racism and its effects on our faculty, staff, students, trainees, patients, visitors, and the communities we serve. Our goal is for Mount Sinai to become an anti-racist health care and learning institution that intentionally addresses structural racism.”
EOE Minorities/Women/Disabled/Veterans
Compensation
The Mount Sinai Health System (MSHS) provides a salary range to comply with the New York City Law on Salary Transparency in Job Advertisements. The salary range for the role is $95450 - $143175 Annually. Actual salaries depend on a variety of factors, including experience, education, and hospital need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.
