Clinical Research Manager - International Center for Health Outcomes
Job description
Strength Through Diversity
The Clinical Research Project Manager will report directly to the Director of Clinical Trials with whom he/she will collaborate on the responsibilities of managing grant-funded and industry sponsored multi-center clinical trials. He/she will ensure that these trials are conducted according to Federal Regulations, GCP, and ICH guidelines.
The Clinical Research Project Manager will take part in all facets of clinical trials from study start-up through publication and study closure. This includes but is not limited to study protocol development, writing operations manuals, designing case report forms, planning/overseeing study conduct, site selection, training of study staff including investigators and coordinators, organizing study meetings (and leading when applicable), and managing/coordinating the day-to-day operational activities associated with conducting multicenter Phase I-IV clinical trials. Work closely with internal stakeholders (trial leadership, monitoring, regulatory, safety, data management and statistics teams) and external stakeholders (sponsors, including the NIH, FDA and industry; core labs and vendors).
- The candidate will assist in recruitment strategies, enrollment tracking, data cleaning for analyses, and manuscript preparation.
- The Clinical Research Project Manager may mentor junior staff.
- Occasional travel may be required when applicable. This candidate will carry a phone for 24-hour availability.
- Strong interpersonal skills.
- Must be able to work independently within the scope of a team environment.
- Attention to detail essential.
- Must possess the ability to work in a dynamic fast-paced environment.
- Experience working in an academic/industry research environment or CRO required.
- Requires a Bachelor's degree. Clinical experience including cardiovascular and/or critical care clinical experience preferred. Degree in Nursing, BSN, and Nurse Practitioner license and/or Master’s degree in healthcare related field preferred.
- Ideal candidate should have a minimum of 3-5 years of relevant work experience in clinical research management, preferably in medical device/pharmacological FDA regulated clinical trials. Previous research management or trial coordination experience preferred.
- Familiarity with web-based databases and proficiency in MS Office software highly desirable. Basic knowledge of statistical analyses required.
- No direct contact with patients, but research compliance training required.
- Participation in medical surveillance required.
Strength Through Diversity
The Mount Sinai Health System believes that diversity, equity and inclusion are drivers for excellence. We share a common devotion to delivering exceptional patient care. Yet we’re as diverse as the city we call home- culturally, ethically, in outlook and lifestyle. When you join us, you become a part of Mount Sinai’s unrivaled record of achievement, education, and advancement as we revolutionize medicine together and participate actively as a leader within the Mount Sinai Health System by:
- Serving as the primary resource management representative of the Mount Sinai leadership teams, committees, etc., and acting as the primary executive leader interface between Mount Sinai and key executives from the health systems’ vendors and partners.
- Engaging with relevant thought leaders and policy-makers at the federal and state levels, and representing the Health System as assigned.
- Using a lens of equity in establishing and promoting policies and procedures and providing opportunities for all to thrive.
- Confronting racist, sexist or other inappropriate behavior and challenges exclusionary organizational practices and serving as a role model to promote anti-racist behaviors.
- Inspiring and fostering an environment of anti-racist behaviors among and between departments and co-workers.
We work hard to acquire and retain the best people, and to create a welcoming, nurturing work environment where you can develop professionally. We share the belief that all employees, regardless of job title or expertise, can make an impact on quality patient care.
Explore more about this opportunity and how you can help us write a new chapter in our story!
Who We Are
Over 42,000 employees strong, the mission of the Mount Sinai Health System is to provide compassionate patient care with seamless coordination and to advance medicine through unrivaled education, research, and outreach in the many diverse communities we serve.
Formed in September 2013, The Mount Sinai Health System combines the excellence of the Icahn School of Medicine at Mount Sinai with seven premier hospital campuses, including Mount Sinai Beth Israel, Mount Sinai Beth Israel Brooklyn, The Mount Sinai Hospital, Mount Sinai Queens, Mount Sinai West (formerly Mount Sinai Roosevelt), Mount Sinai Morningside (formerly Mount Sinai St. Luke’s), and New York Eye and Ear Infirmary of Mount Sinai.
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.
EOE Minorities/Women/Disabled/Veterans
Employer Description
- 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.
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 $71713 - $107569 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.
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