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clinical trials manager

Columbia University

<div><ul><li>Job Type: Officer of Administration</li>
<li>Bargaining Unit:</li>
<li>Regular/Temporary: Regular</li>
<li>End Date if Temporary:</li>
<li>Hours Per Week: 35</li>
<li>Standard Work Schedule: M-F; 9AM-5PM</li>
<li>Building:</li>
<li>Salary Range: $100,000.00 - $135,000.00</li>
</ul><div>The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.</div> 
<div></div>

Position Summary

This position will support the development and growth of a department‑wide Dermatology Clinical Trials Unit under the direction of the Vice Chair for Clinical Research.

The Clinical Research Program Manager will oversee operational infrastructure for clinical and translational research across multiple faculty investigators. The individual will help build a scalable clinical research program that integrates clinical trials, translational research, and collaborative initiatives across Columbia University Irving Medical Center.

This role combines strategic program management with operational leadership and hands‑on clinical research expertise. The successful candidate will help develop workflows, supervise research staff, coordinate regulatory and operational activities, and ensure efficient study activation and execution. This position also requires the ability to step into Clinical Research Coordinator responsibilities, when necessary, particularly during early program growth, study startup, or smaller investigator‑initiated studies.

Position Goals
<ul>
<li>Build and support department-wide Dermatology Clinical Trials Unit</li>
<li>Expand clinical and translational research across department</li>
<li>Support multiple investigators</li>
<li>Improve study activation timelines</li>
<li>Increase patient access to clinical trials</li>
<li>Strengthen collaboration across Columbia research network</li>
</ul>
Reporting Structure

The Clinical Research Program Manager will report to the Vice Chair for Clinical Research within the Department of Dermatology and work closely with Department Chair, faculty investigators, and institutional research leadership.

Responsibilities

Clinical Research Program Development

The Clinical Research Program Manager will work closely with the Vice Chair for Clinical Research to build a department‑wide research infrastructure that supports multiple investigators and study types. This includes developing standardized workflows, supporting new trial development, coordinating operational infrastructure, and helping expand clinical and translational research across dermatology. The individual will help create processes for study prioritization, resource allocation, and staff deployment across investigators, ensuring efficient and scalable program growth. 
The Clinical Research Program Manager will conduct clinical trial operations, including but not limited to:
<ul>
<li>Oversee study startup, activation, and execution across multiple investigators</li>
<li>Coordinate feasibility assessments for new studies</li>
<li> Ensure regulatory and operational compliance</li>
<li> Monitor study timelines and enrollment targets</li>
<li> Support study closure and reporting</li>
<li> Direct clinical research activities (as needed)</li>
<li> Perform CRC duties when necessary</li>
<li> Assist with patient screening and enrollment</li>
<li> Support consenting and study visits</li>
<li> Assist with data collection and documentation</li>
<li> Support early-phase and underfunded studies</li>
</ul>
Translational Research and Biobanking

The role will include coordination of translational research activities including biospecimen collection, tissue‑based research, biomarker studies, and biobanking. The Program Manager will work with investigators and laboratory collaborators to ensure proper specimen handling, regulatory compliance, and integration of translational research components into clinical trials. This individual will help develop infrastructure supporting translational studies and ensure alignment between clinical and laboratory‑based research.
<ul>
<li>Coordinate translational research components of clinical trials</li>
<li>Oversee biospecimen collection and biobanking activities</li>
<li>Support biomarker-driven and tissue-based studies</li>
<li>Coordinate with laboratory and translational research collaborators</li>
<li>Ensure regulatory compliance for biospecimen collection and storage</li>
</ul>
Institutional Collaboration

The Clinical Research Program Manager will work closely with institutional partners including the Clinical Trials Office (CTO), Sponsored Projects Administration (SPA), Institutional Review Board (IRB), various cancer center programs, and other stakeholders. The individual will facilitate communication and coordination between dermatology investigators and institutional resources to improve study activation timelines and support program growth.

Team Leadership and Staff Management

The Program Manager will supervise clinical research coordinators and support staff, assist with hiring and onboarding, and provide training and mentorship. The individual will help develop scalable and overlapping staffing models, and coordinate research personnel across multiple investigators and studies. Specifically:
<ul>
<li>Supervise clinical research coordinators and research staff</li>
<li>Assist in hiring and onboarding research staff</li>
<li>Train and mentor clinical research coordinators</li>
<li>Develop scalable staffing structure</li>
<li>Coordinate staff across multiple investigators</li>
<li>Provide operational support to multiple faculty investigators</li>
<li>Support investigator-initiated trials</li>
<li>Assist with early-phase and translational studies</li>
<li>Facilitate collaboration across investigators</li>
<li>Support development of new clinical trials</li>
</ul>
Financial and Operational Oversight
<ul>
<li>Assist with clinical trial budgeting</li>
<li>Track financial performance of research portfolio</li>
<li>Monitor study revenue and operational costs</li>
<li>Support financial sustainability of program</li>
</ul>
Quality and Compliance
<ul>
<li>Develop and maintain SOPs</li>
<li>Ensure regulatory compliance</li>
<li>Prepare for audits and monitoring visits</li>
<li>Implement quality improvement initiatives</li>
</ul>
Minimum Qualifications
<ul>
<li>Bachelor&rsquo;s degree in life sciences, health sciences, or related field</li>
<li>Minimum 5 years clinical research experience</li>
<li>Experience managing multiple clinical trials</li>
<li>Experience with regulatory submissions and IRB processes</li>
<li>Knowledge of Good Clinical Practice (GCP)</li>
</ul>
Preferred Qualifications
<ul>
<li>Master&rsquo;s degree preferred</li>
<li>Experience in academic medical center</li>
<li>Experience supervising research staff</li>
<li>Experience with translational research and biospecimen collection</li>
<li>Experience with investigator-initiated trials</li>
<li>Experience with industry-sponsored trials</li>
</ul>
Other Requirements

The ideal candidate will be highly organized, collaborative, and capable of working in a complex academic medical center environment. The individual must be comfortable managing multiple priorities, working with diverse investigators, and building operational infrastructure from the ground up. Strong communication skills, leadership ability, and experience navigating institutional processes are essential. The candidate should demonstrate initiative, flexibility, and the ability to transition between strategic planning and hands‑on operational work. The role requires a proactive individual who can anticipate challenges, develop solutions, and support the growth of a department‑wide clinical research program.

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.</div>

Clinical Research Manager

Mount Sinai Health System

<div>Description
The Clinical Program Manager provides clinical support and administrative direction within the Tisch Cancer Center&rsquo;s Clinical Trials Office (TCC CCTO). 
In collaboration with the Associate Director for Research, clinical trials investigators, and TCC CCTO Administrative Directors; this candidate is responsible for the implementation and conduct of clinical trials with investigational anti-cancer agents in the Cancer Institute. The Candidate must have expert knowledge of cancer as a disease process, cancer treatment modalities, 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. The Clinical Program Manager will report into the CCTO&rsquo;s Administrative Director. 
Responsibilities
Administrative Responsibilities:<ul><li>
Supervises Clinical Research Coordinator positions and other CRNs to ensure protocol compliance, accurate data collection and sample acquisition.</li><li>
Develops educational programs for the Nursing Staff regarding specific protocols.</li><li>
Manage clinical trials portfolio and assure timely regulatory start-up of protocols.</li><li>
Monitor accruals and identify opportunities to grow research program.</li><li>
Liaison with industry sponsors and CROs.</li><li>
Liaison with CCTO office (including pre-award, post award and QAP).</li></ul> 
Clinical Research Responsibilities:<ul><li>
Responsible for coordinating study enrollment, establishing a database of patients, protocol treatment and follow-up care for patients participating in clinical trials.</li><li>
Collaborates with primary nursing staff to provide nursing care to patients receiving therapy on a clinical research trial.</li><li>
Assists the principal investigator in the process of assuring adequate informed consent.</li><li>
Assures the primary nursing staff understands how to administer investigational agents per specifications of the protocol.</li><li>
Assures 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 patient&rsquo;s chart and all other databases as required.</li><li>
In collaboration with the Nursing Staff, assesses patients on study for complications related to therapy.</li><li>
Communicates observations/findings to attending physicians and in medical records are required.</li><li>
Ensures that drug dosing and sample collections times are recorded on study worksheets.</li><li>
Provides in-service training and serves as a resource to other clinical personnel including physicians, nurses, pharmacists, and other allied health care professionals.</li><li>
Communicates with referring and affiliated physicians to ensure documentation of clinical findings throughout the clinical trial.</li><li>
Collaborates with attending physicians to identify and recruit patients eligible for clinical trial.</li><li>
Establishes and maintains database of prospective patients for clinical trials within CTMS.</li><li>
Oversees scheduling of patient laboratory and radiologic assessments, admissions, and clinic visits.</li><li>
Establishes mechanisms to ensure complete and accurate data collection and documentation.</li></ul> 
Clinical Responsibilities:<ul><li>
The Clinical Program Manager is responsible for assuring compliance with mandated clinical interventions inclusive of core measures within the department and the Medical Center. This individual interfaces directly with MSMC Departments, Administrators, Nursing, Medical and Quality Leadership, and Clinical Staff, overseeing administrative and daily operations of the core measures and clinical intervention compliance program.</li><li>
In conjunction with Nursing, Medical and Quality Leadership, coordinates core measures and clinical intervention compliance activities</li><li>
Assists in development and design of action plans to support compliance with measures indicators and provides support and educational resources to departments and services relative to core measures quality assessment and improvement processes.
</li><li>Assists in establishing and implementing short- and long-term goals, objectives, policies and operating procedures for core measures programs.</li><li>
Provides coordination and leadership in the execution of day-to-day program activities, as appropriate to program objectives and areas of expertise.</li><li>
Oversees the collection, compilation, and analysis of clinical program activity data.</li><li>
Provides technical assistance, resource services, consultation and education to clinical departments relative to core measures activities.</li></ul> 

Qualifications<ul><li>
Baccalaureate Degree in Nursing is required. Masters in Nursing or health related field is preferred</li><li>
Certification in specialty area preferred</li><li>
5 years directly related experience (some supervisory preferred)</li><li>
New York State License with current registration as a registered professional nurse</li></ul> 

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&rsquo;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 &mdash; 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&rsquo; 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 &amp; World Report's Best Hospitals, receiving high &quot;Honor Roll&quot; 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 &amp; World Report&rsquo;s &ldquo;Best Children&rsquo;s Hospitals&rdquo; ranks Mount Sinai Kravis Children's Hospital among the country&rsquo;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&rsquo;s &ldquo;The World&rsquo;s Best Smart Hospitals&rdquo; 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 $115494 - $192328 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.</div>

Clinical Program Manager, Oncology Research (NP or RN Required) - Tisch Cancer Center

<div><ul><li>Job Type: Officer of Administration</li>
<li>Bargaining Unit:</li>
<li>Regular/Temporary: Regular</li>
<li>End Date if Temporary:</li>
<li>Hours Per Week: 35</li>
<li>Standard Work Schedule:</li>
<li>Building:</li>
<li>Salary Range: $100,000-$110,000</li>
</ul><div>The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.</div> 
<div></div>

Position Summary

The candidate will be an integral member of the senior leadership team within the Clinical Protocol &amp; Data Management (CPDM) Office of the Herbert Irving Comprehensive Cancer Center (HICCC). Responsibilities include but are not limited to: coordinating the data management activities of the CPDM, while providing supervision and delegation of work assignments and evaluation of the CPDM Clinical Research Coordinators (CRCs) and Data Coordinators(DCs); creating and promoting professional development opportunities (both internally and externally) for staff; implementing processes and that improve, streamline, and stimulate the work environment; continually assessing trial complexity/workload and resource allocation to ensure patient safety and clinical research excellence; ensuring and promoting positive relationships and outcomes with private industry and other external agencies.

The Clinical Research Manager reports directly to the Assistant Director, Clinical Research Operations.

Subject to business needs, we may support flexible and hybrid work arrangements. Options will be discussed during the interview process.

Responsibilities

STAFFING
<ul>
<li>Posts/justifies new and replacement positions, screens applicants</li>
<li>On-boards and trains staff (protocol, university, departmental training)</li>
<li>Liaises with the HICCC HR representative for scheduling medical surveillance, JCAHO, and other HR-related functions</li>
<li>Makes appropriate salary recommendations for new and existing staff based on prior experience and conducts annual staff performance reviews (including establishing and continually monitoring FY goals)</li>
</ul>
SUPERVISION
<ul>
<li>Monitors, directs, and supervises staff in a manner that facilitates efficient level of operations</li>
<li>Determines CRC and DC workloads and protocol assignments</li>
<li>Assures the subject data collected by the CRCs is organized and submitted in a timely manner</li>
<li>Develops quality control mechanisms to ensure accurate data reporting</li>
<li>Assists with CRF development, accuracy, and implementation for investigator initiated trials</li>
<li>Ensures CRC&rsquo;s are adequately prepared for and successfully manage all monitoring and/or auditing visits
</li>
</ul>PROTOCOL/DISEASE BASE TEAM MANAGEMENT
<ul>
<li>Provides protocol management and research expertise by participating in discussions at disease team and collaborative research meetings, ensuring operational feasibility, compliance, and strategic alignment with CPDM and Cancer Center goals.</li>
<li>Leads ongoing assessment of trials within the portfolio to evaluate feasiblity, accrual trends, and resource utilization. Implements priority scoring and portfolio review processes to ensure staffing and support are aligned with institutional priorities and study performance.</li>
Organizes and coordinates project activities, collaborating with multidisciplinary teams - including investigators, research nurses, coordinators and regulatory staff <li>- to ensure timely completion of study start-up, activation, and conduct.</li>
<li>Represents the department at conferences and meetings, maintaining effective communication channels between clinical, research, and administrative stakeholders to promote consistent study management, issue resolution, and operational best practices.</li>
</ul>
FINANCE MANAGEMENT
<ul>
<li>Prepares and reviews study budgets for submission, negotiation, and ongoing financial monitoring to ensure accuracy, compliance, and alignment with departmental standards.</li>
<li>Monitors, reports, and interprets variances to approved budgets. Collaborates with the Assistant Director to develop and execute action plans that address financial gaps and optimize resource utilization. Uses forecasting tools to project financial outcomes and proactively identify risks and opportunities.</li>
<li>Implements strategies to support financial stability and operatinal efficiency across assigned studies and departmental functions. Ensures financial practices align with institutional priorities, long-term sustainability goals, and portfolio management objectives.</li>
</ul>
DEPARTMENT INITIATIVES
<ul>
<li>Assist the CPDM Leadership Team in developing, implementing, and executing departmental Standard Operating Procedures (SOPs).</li>
<li>Develop standardized forms, study tools, and promote cross-coverage with CPDM Leadership to ensure coverage, provide appropiate staff updates, in-services, trainings, etc.</li>
</ul>
OTHER
<ul>
<li>Performs other related duties as assigned.</li>
</ul>
Minimum Qualifications
<ul>
<li>Bachelor&rsquo;s Degree or equivalent in education, training and experience, plus 4 years of related experience.</li>
</ul>
Preferred Qualifications
<ul>
<li>Certification as a Clinical Research Professional through a national accrediting body such as ACRP and/or SoCRA.</li>
</ul>
Other Requirements
<ul>
<li>Minimum one year of supervisory experience.</li>
<li>Experience in clinical research setting necessary, including a thorough understanding of ICH-GCP and CFR guidelines.</li>
<li>Excellent interpersonal and organizational skills.</li>
<li>Computer skills, proficiency with MS Office products (Word, Excel, PowerPoint).</li>
</ul>
Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.</div>

<div>Description<div>
The Clinical Research Program Director will lead the operational, regulatory, financial, and strategic coordination of a clinical and translational immunology research portfolio focused on the development and clinical implementation of cellular therapies for non-oncologic diseases.</div><div>
This role bridges basic science, translational research, and clinical trials, with a strong emphasis on regulatory execution, including IND submissions to the FDA for both drug and cellular therapy products.</div><div></div><div> 
The ideal candidate brings deep experience in academic clinical research environments, IND-enabling activities, and early-phase clinical trials, and is comfortable managing complex, multi-stakeholder programs involving investigators, regulatory bodies, and institutional committees.</div><div></div><div> 
Why Join Us</div><div>
This is a unique opportunity to help build and scale a cutting-edge translational immunology program advancing cellular therapies beyond oncology into new therapeutic areas. The Clinical Research Program Director will organize a hub-and-spoke model, within the Lipschultz Precision Immunology Institute at Icahn School of Medicine (PrIISM) serving as the central coordinating hub and clinical departments/divisions functioning as disease-specific spokes.</div>
Responsibilities<div>
Program &amp; Portfolio Management</div><ul><li>
Oversee day-to-day management of translational research programs in immunology and cellular therapy</li><li>
Coordinate cross-functional teams including faculty, clinical research staff, GMP facilities, regulatory affairs, and external collaborators</li><li>
Develop and manage project timelines, milestones, budgets, and deliverables across preclinical and clinical phases</li><li>
Track progress of multiple concurrent studies and ensure alignment with institutional and sponsor priorities</li></ul><div>
Clinical Trials &amp; Translational Research</div><ul><li>
Support design, startup, and execution of early-phase (Phase I/II) clinical trials involving cellular therapies for non-cancer indications</li><li>
Coordinate activities spanning pre-clinical development, IND-enabling studies, and clinical implementation</li><li>
Interface with clinical operations teams to ensure protocol adherence, subject safety, and data compliance/ integrity</li></ul><div>
Regulatory Strategy &amp; IND Submissions</div><ul><li>
Lead preparation, coordination, and submission of Investigational New Drug (IND) applications to the FDA, including for cell and gene therapy products</li><li>
Manage regulatory documentation (e.g., protocols, investigator brochures, CMC sections, pharmacology/toxicology data)</li><li>
Serve as liaison with FDA and support responses to information requests, clinical holds, and annual reports</li><li>
Ensure compliance with GCP, GMP, and applicable regulatory requirements</li></ul><div>
Operational &amp; Institutional Navigation</div><ul><li>
Guide studies through internal review processes (e.g., IRB, biosafety, data use, and institutional committees)</li><li>
Coordinate with technology transfer, legal, and compliance offices as needed</li><li>
Establish and refine workflows to streamline translational research operations within the department</li></ul><div>
Collaboration &amp; Communication</div><ul><li>
Serve as a central point of coordination between investigators, institutional leadership, sponsors, and external partners</li><li>
Prepare reports, presentations, and updates for internal stakeholders and funding agencies</li><li>
Facilitate multidisciplinary meetings and ensure clear communication across teams</li><li>
Performs other related duties.</li></ul>
Qualifications<ul><li>
Bachelor&rsquo;s degree required. Master&rsquo;s degree in life sciences, public health, regulatory science, or a related field strongly preferred. Advanced clinical or doctoral degrees (PhD, MD, RN, or equivalent) are also strongly preferred.</li><li>
Minimum of 7 years of experience in a hospital or medical environment, preferably within human subjects or clinical trials research, including at least 3 years of supervisory experience.</li><li>
Demonstrated experience managing clinical trials, particularly early-phase or investigator-initiated studies</li><li>
Direct experience preparing and submitting IND applications to the FDA, including cellular therapy and/or biologic products</li><li>
Experience in translational medicine, ideally in immunology or cell therapy (non-oncology focus preferred)</li></ul><div> 
Skills &amp; Knowledge</div><ul><li>
Strong understanding of FDA regulatory pathways, especially IND requirements for drugs and cell-based therapies</li><li>
Familiarity with GCP, GMP, and IND-enabling preclinical requirements</li><li>
Proven ability to manage complex, multidisciplinary programs and timelines</li><li>
Excellent organizational, communication, and stakeholder management skills</li><li>
Ability to navigate academic institutional processes and regulatory committees</li></ul> 
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&rsquo;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 &mdash; 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&rsquo; 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 &amp; World Report's Best Hospitals, receiving high &quot;Honor Roll&quot; 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 &amp; World Report&rsquo;s &ldquo;Best Children&rsquo;s Hospitals&rdquo; ranks Mount Sinai Kravis Children's Hospital among the country&rsquo;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&rsquo;s &ldquo;The World&rsquo;s Best Smart Hospitals&rdquo; 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 $115494 - $194020.12 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.</div>

Clinical Research Program Director in Cellular Therapy and Biologics for Non-Oncology Diseases (Immunology and Immunotherapy)

<div><ul><li>Job Type: Officer of Administration</li>
<li>Bargaining Unit:</li>
<li>Regular/Temporary: Regular</li>
<li>End Date if Temporary:</li>
<li>Hours Per Week: 35</li>
<li>Standard Work Schedule:</li>
<li>Building:</li>
<li>Salary Range: $66,300-$68,000</li>
</ul><div>The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.</div> 
<div></div>

Position Summary
<div>
The Clinical Research Coordinator manages clinical trials conducted through the Clinical Protocol &amp; Data Management Office. This position reports directly to the Clinical Research Manager of the specific disease site this incumbent is assigned to. Subject to business needs, we may support flexible and hybrid work arrangements. Options will be discussed during the interview process.
</div>
Responsibilities

The Clinical Research Coordinator manages clinical trials (including some regulatory and budget requirements) and assists in the coordination of tests/visits for patients, working with the study team to maximize work efficiency to gather all required data and relevant clinical information.

Responsibilities include, but are not limited to:
<ul>
<li>GENERAL STUDY MANAGEMENT
<ul><li>Reviewing research protocols.</li>
<li>Assisting Principal Investigators in study start up and submitting studies to appropriate offices.</li>
<li>Interacting with the regulatory team to maintain regulatory documentation and administrative files for each protocol</li>
<li>Under the supervision of the clinical research manager, the coordinator maintains procedures necessary for timely and complete data management, and complies with required supervision tools such as work logs and regular meetings. The coordinator will also comply with necessary regulatory responsibilities as needed.</li>
</ul></li></ul><ul><li>PATIENT MANAGEMENT 
<ul><li>Coordinates study enrollment, protocol treatment, and follow-up care for patients participating in clinical trials in conjunction with the clinical research nurse, research pharmacy, treatment center and other study staff.</li>
<li>Working with the research nurse, treating physicians, and Principal Investigators to confirm that each patient meets eligibility criteria specified for protocols and enrollment into clinical trials.</li>
<li>Communicating with various departments, physicians, labs, outside hospitals, and all members of the clinical team to ensure accuracy, timely retrieval of data, and confirm the appropriateness and timeliness of tests.</li>
<li>Collecting follow-up data on patients' post-treatment as required by the protocol and submit monthly reports to the clinical protocol office, tracking patient enrollment and accounts/payments for sponsored protocols.</li>
<li>Completes timely research billing review</li>
<li>Maintains and updates sponsor-related, university and department databases/logs</li>
</ul></li></ul><ul><li>DATA MANAGEMENT
<ul><li>Handling data management requirements for each patient enrolled.</li>
<li>Abstracts, assembles, and organizes clinical research data.</li>
</ul></li></ul><ul><li>OTHER
<ul><li>Coordinator performs other related duties and participates in special projects as assigned.</li>
<li>Perform other related duties and responsibilities as assigned/requested.</li>
</ul>
</li></ul>Minimum Qualifications
<ul>
<li>Bachelor&rsquo;s degree or equivalent in education and/or experience.</li>
</ul>
Preferred Qualifications
<ul>
<li>Two years of related experience or equivalent in education.</li>
<li>Excellent interpersonal and organizational skills.</li>
<li>Computer Skills: proficiency with MS Word programs and familiarity with Mac and PC platforms.</li>
<li>Experience in clinical research setting with knowledge of HIPAA and GCP.</li>
</ul>
Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.</div>

Clinical Research Coordinator I

Columbia University Irving Medical Center

<div>
 Grade 103
 
 
 <ul>
 <li>
 Job Type: Officer of Administration
 </li>
 <li>
 Bargaining Unit:
 </li>
 <li>
 Regular/Temporary: Regular
 </li>
 <li>
 End Date if Temporary:
 </li>
 <li>
 Hours Per Week: 35
 </li>
 <li>
 Standard Work Schedule:
 </li>
 <li>
 Building:
 </li>
 <li>
 Salary Range: $66,300 - $68,000
 
 
 </li>
 </ul>
 
 The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.
 
 
 
 Position Summary
 
 
 Columbia University Irving Medical Center (CUIMC) provides global leadership in scientific research, health and medical education, and patient care. Working in the Clinical Protocol &amp; Data Management office in the Herbert Irving Comprehensive Cancer Center under the direct supervision of the Clinical Research Manager (CRM) or the specific disease site this incumbent is assigned to, the Clinical Research Coordinator (CRC) I will support the coordination of clinical research activities according to clinical research studies or trials managed by the department.
 
 
 In general, the CRC I will be responsible for the coordination of patient participation (including screening, recruitment, assessment, and follow-up of study participants), collection and maintenance of study data, ensuring adherence to study activities as described in the protocol, and working with other members of the research team to coordinate all other aspects related to the conduct of the clinical trial or study.
 
 
 This position is primarily based out of the Herbert Irving Pavilion, 161 Fort Washington Avenue, Mezzanine level, New York, NY. Subject to business needs, we may support flexible and hybrid work arrangements. Options will be discussed during the interview process.
 
 
 
 Responsibilities
 
 
 
 The CRC I manages clinical trials (including some regulatory and budget requirements) and assists in the coordination of tests/visits for patients, working with the study team to maximize work efficiency to gather all required data and relevant clinical information.
 
 
 
 Responsibilities Include, But Are Not Limited To
 
 
 
 
 GENERAL STUDY MANAGEMENT
 
 
 
 <ul>
 <li>
 Reviewing research protocols.
 </li>
 <li>
 Assisting Principal Investigators in study start up and submitting studies to appropriate offices.
 </li>
 <li>
 Interacting with the regulatory team to maintain regulatory documentation and administrative files for each protocol.
 </li>
 <li>
 Under the supervision of the clinical research manager, the coordinator maintains procedures necessary for timely and complete data management and complies with required supervision tools such as work logs and regular meetings. The coordinator will also comply with necessary regulatory responsibilities as needed.
 </li>
 <li>
 Responsible for day-to-day aspects of study protocol tasks including participant recruitment, screening, enrollment and follow-up with study participants, specimen processing, and other key protocol elements under direct supervision.
 </li>
 <li>
 Effectively communicate and maintain relationships with potential study subjects, participants, clinicians, other health care providers, sponsors, and research office staff to support the successful administration of clinical trials.
 </li>
 <li>
 Assist with the coordination of research team meetings, investigator check-ins, Sponsor visits, external audits, and other stakeholder engagement activities. Supports research team members on various clinical trials or study related tasks.
 </li>
 <li>
 Ensures timely notification and/or communication between the Principal Investigator and compliance offices and study sponsors.
 </li>
 <li>
 Maintain accurate and complete clinical research files which may include administering questionnaires, assisting preparation and completion of case report forms (CRFs), and completing any study start-up or close-out documentation, and adverse event (AE) reporting.
 </li>
 <li>
 Possess understanding and awareness of Corrective and Preventative Actions (CAPA).
 </li>
 <li>
 Coordinate financial transactions related to the study, including but not limited to compensation to study subjects for their participation and helping them to troubleshoot any issues.
 </li>
 <li>
 Adhere to workplace and patient safety protocols, monitor the area and ensure compliance with ethical and safety standards for research, and maintain research supply inventory, requesting additional items as needed.
 
 
 </li>
 </ul>
 
 PATIENT MANAGEMENT
 
 
 
 <ul>
 <li>
 Coordinates study enrollment, protocol treatment, and follow-up care for patients participating in clinical trials in conjunction with the clinical research nurse, research pharmacy, treatment center and other study staff.
 </li>
 <li>
 Working with the research nurse, treating physicians, and Principal Investigators to confirm that each patient meets eligibility criteria specified for protocols and enrollment into clinical trials.
 </li>
 <li>
 Communicating with various departments, physicians, labs, outside hospitals, and all members of the clinical team to ensure accuracy, timely retrieval of data, and confirm the appropriateness and timeliness of tests.
 </li>
 <li>
 Collecting follow-up data on patients' post-treatment as required by the protocol and submit monthly reports to the clinical protocol office, tracking patient enrollment and accounts/payments for sponsored protocols.
 </li>
 <li>
 Completes timely research billing review
 </li>
 <li>
 Maintains and updates sponsor-related, university and department databases/logs
 </li>
 <li>
 Represent Columbia University Irving Medical Center research as one of its frontline health research personnel and commit to using culturally appropriate communication methods.
 
 
 </li>
 </ul>
 
 DATA MANAGEMENT
 
 
 
 <ul>
 <li>
 Handling data management requirements for each patient enrolled.
 </li>
 <li>
 Abstracts, assembles, and organizes clinical research data.
 </li>
 <li>
 Complete data entry activities with supervision and support as needed. Data entry may include Protected Health Information (PHI), clinical and billing or other administrative data.
 
 
 </li>
 </ul>
 
 Other
 
 
 
 <ul>
 <li>
 Coordinator performs other related duties and participates in special projects as assigned.
 </li>
 <li>
 Perform other related duties and responsibilities as assigned/requested.
 
 
 </li>
 </ul>
 
 Minimum Qualifications
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree or equivalent in education and/or experience.
 
 
 </li>
 </ul>
 
 Preferred Qualifications
 
 
 
 <ul>
 <li>
 Two years of related experience or equivalent in education.
 </li>
 <li>
 Must possess critical thinking and analytical skills, customer-service orientation, with the ability to interact and collaborate positively, constructively and effectively with multiple stakeholders.
 </li>
 <li>
 Capacity to work semi-independently and successfully within a team in a deadline driven, multi-tasking environment.
 </li>
 <li>
 Strong oral and written communication skills.
 </li>
 <li>
 Strong commitment to fostering diversity and equity.
 </li>
 <li>
 Skilled with Microsoft Office, including strong Excel skills.
 </li>
 <li>
 Ability and willingness to learn new systems and programs.
 </li>
 <li>
 Bilingual (Spanish and English).
 </li>
 <li>
 At least 2 years of experience in a relevant clinical research field.
 </li>
 <li>
 Familiarity with Columbia health and research systems.
 </li>
 <li>
 Education in a scientific, health-related, or business administration program or experience with observational research or in laboratory settings.
 </li>
 <li>
 Experience with electronic medical records and/or research data entry, including Epic, REDCap, Qualtrics, iLab, or OpenSpecimen.
 </li>
 <li>
 Knowledge of clinical research systems and processes, Good Clinical Practice (GCP) guidelines, HIPAA, Columbia IRB and other institutional or federal regulatory and compliance activities.
 
 
 </li>
 </ul>
 Equal Opportunity Employer / Disability / Veteran
 
 
 Columbia University is committed to the hiring of qualified local residents.
</div>

<div><ul><li>Job Type: Officer of Administration</li>
<li>Bargaining Unit:</li>
<li>Regular/Temporary: Regular</li>
<li>End Date if Temporary:</li>
<li>Hours Per Week: 35</li>
<li>Standard Work Schedule:</li>
<li>Building:</li>
<li>Salary Range: $66,300.00 - $78,000.00</li>
</ul><div>The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.</div> 
<div></div>

Position Summary

The position is responsible for collaborating with Principal Investigators (PI) and their team as well as working independently to coordinate clinical research studies and trials. The research team is highly synergistic and works in a fast-paced, dynamic environment to advance knowledge in pediatric heart disease. This role is well-suited for an energetic self-starter who enjoys learning and the challenge of solving problems that improve people&rsquo;s lives. The candidate would report to the PI and the Director of Research for the Clinical Research Core in the Department of Pediatrics. The clinical research coordinator will have strong organizational, multi-tasking, time management, communication, and team skills to join our team in the assessment of outcomes, value of care, and health inequities for children for congenital heart disease.

At CUIMC, we are leaders in teaching, research, and patient care and are proud of the service and support we provide to our community. Columbia University offers a range of benefits to help you, and your dependents stay healthy, build long-term financial security, meet educational and professional goals, and more. Explore your options for Health and Welfare, Employee Assistance, Tuition Programs, and Retirement Benefits.

Responsibilities
<ul>
<li>Working directly with the PIs and other team members to prioritize day-to-day study operations and direct investigations.</li>
<li>Follow-up on cardiac surgery patients for routine parent-reporting outcomes data.</li>
<li>Identifying and screening potential participants to determine eligibility.</li>
<li>Participate in the informed consent process and Randomizing participants.</li>
<li>Completing case report forms.</li>
<li>Assisting with scheduling of tests and appointments.</li>
<li>Managing data collection and submission and maintaining relevant databases; consulting medical records as necessary to obtain pertinent data.</li>
<li>Collecting, processing, and shipping protocol specimens.</li>
<li>Preparing/monitoring study budgets and regulatory documents for IRB submissions, data use agreements, and contracting.</li>
<li>Directing communications with patients and collaborators</li>
<li>Assisting with grant and manuscript writing</li>
<li>Develop plans for protocol implementation, identify necessary resources and request as appropriate. This includes instruments, equipment and staff.</li>
<li>Assist the Research Manager in the preparation of study budgets, research related cost estimate forms, and initiation of all new adult research studies and trials.</li>
<li>Provide assistance to all other research staff members that are involved in the research trials and studies.</li>
<li>Performs related duties &amp; responsibilities as assigned/requested.</li>
</ul>
Minimum Qualifications
<ul>
<li>Bachelor&rsquo;s degree or equivalent in education and experience required.</li>
</ul>
Preferred Qualifications
<ul>
<li>Two years of related experience.</li>
<li>Minimum two years of related, paid experience as a research assistant, project manager, research coordinator, research administrator, or similar job preferred.</li>
<li>Excellent verbal and written communication and interpersonal skills.</li>
<li>Strong organizational and time management skills</li>
<li>Proficiency in MS Office, specifically Word, Excel, PowerPoint, and Outlook, is required</li>
<li>Familiarity with reviewing electronic medical records</li>
<li>Familiarity with Redcap and other data management sources</li>
<li>Previous or active CCRC/CCRP certification is preferred.</li>
</ul>
Other Requirements
<ul>
<li>Employment is contingent upon successful completion of pre-offer and post-offer background checks in accordance with NYC&rsquo;s Fair Chance Act. Depending on the position, a drug screening and other verifications may be required. (University Policies)</li>
<li><ul><li>Must successfully complete applicable compliance and systems training requirements.</li>
</ul><ul><li>HIPAA Privacy and Security Essentials Training.</li>
</ul>
</li></ul>Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.</div>

Clinical Research Coordinator

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