Senior Clinical Research Associate - Cardiology - Military veterans preferred

Job DescriptionThe Senior Clinical Research Associate manages all aspects of clinical research trial(s) coordination including activities involved in the planning, conduct and completion of a clinical trial(s) at multiple sites. Depending on the department and clinical trial there may be significant travel time required.Unique International Collaborative Team for MPNs: The MPD Clinical Consortium is the only large, multi-centered, international academic collaboration involving 45 clinical centers within the USA and 7 other countries that is focused on developing scientifically based, hypothesis testing clinical trials for the treatment of MPN patients. No other large scale, independent, federally funded, collaborative effort for scientific advances in MPNs exists other than the MPD-RC. This has been established as a result of prior funding of a PO1 and will be reliant on continued support of this grant.Our overarching clinical trial focus is the evaluation of rationally based therapies that target the MPN HSC and/or the corrupt bone marrow microenvironment providing an opportunity to modify the course of these chronic progressive malignancies. In doing so, each trial is designed to evaluate clinical responses in conjunction with thoughtful correlative biomarkers that provide insight into a) drug pharmacokinetics, b) Pharmacodynamics studies demonstrating achievement of drug target inhibition/activation, c) reduction in clonal burden of the MPN HSC, d) potential mechanisms of drug resistance, and e) enhanced understanding of the molecular pathobiological mechanisms underlying MPNs.ResponsibilitiesLeads the coordination of the clinical trial(s).Clinical study life-cycle responsibilities include involvement in the selection of sites, management of the training of study site personnel (including investigators and coordinators), planning and oversight of national study meetings, and management/coordination of the day-to-day operational activities associated with conducting and closing out Phase I through Phase IV, and post-marketing studies.Assists in the recruitment strategies and enrollment tracking, data analyses and manuscript preparation.Prepares and completes critical study documents and performs final editing/proofing prior to release of document (e.g. protocol; synopsis; flowchart; informed consent template; investigator brochure; monitoring guideline; statement of work laboratory, other vendors, and CROs; consultant agreements; investigative device/drug labels; clinical study worksheets; etc.).Contributes to the development of Standard Operating Procedures (SOPs), work practices, and clinical guidelines.Establishes timeline and target dates for completion of study milestones in collaboration with trial leadership. Utilizes data reports and site metrics to deliver milestones on time and budget.In collaboration with team members, monitors clinical trial sites, all clinical studies, and the documentation of all findings, outcomes, and agreements.Assures all clinical site trial documentation is maintained in compliance with all applicable guidelines and corresponding procedures documents.Participates, with the CTM, in the preparation and hosting of clinical study team meetings on an established schedule, providing agenda, recording/distributing of minutes and copying of minutes to CTM.May work with the CTM to prepare and compile materials for clinical study conduct and reference information for study sites provided to the site in the form of an investigator site file (ISF).Prepares, distributes, collects and archives all study related correspondence to the investigator clinical sites including, but not limited to, newsletters, Dear Dr. letters, FDA/HA correspondence, contractual agreements and others.Responsible for investigator recruitment and maintaining current contact information for each assigned investigator site, as well as preparing investigator site file for participation approval.Collects pre-study documentation and essential regulatory documents from assigned investigator sites, as well as, collects updated documents prior to study initiation and on an ongoing basis.Estimates, orders and coordinates shipments of clinical study supplies to assigned investigator sites.May track and request grant payments, and maintain study budget, or assist the CTM with budget and paymentsTracks and reports all adverse events, protocol deviations, and any other unusual activity experienced by assigned investigator sites and communicates with assigned sites on routine matters.Reviews all adverse events reported in clinical study for the identification and evaluation of safety issues and any patterns that are identifiable.Reports safety findings in a summary format to the CTM.Prepares documentation for and attends required meetings, participates in adjudication meetings, documents results, assists in entering of adjudication data and dissemination of results to clinical sites, if applicable.Identifies and documents data errors or items requiring clarification on all documents collected for study and initiates data clarification/validation process after researching source documents.Prepares clinical reports of assigned projects for submission to regulatory authorities.Performs other duties as required.QualificationsBachelors Degree in life sciences or BSN4-5 years experience in Phase I-IV clinical studies as a clinical research associateAbout UsStrength 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