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lead clinical research coordinator

IQVIA

<div>New York, United States of America | Part time | Office-based | R1543649</div>
<br><div><div><h3 class="jobSectionHeader"><b>Clinical Research Coordinator - New York, NY</b><br>
<b>Work Set‑Up:</b><b> On‑site</b><br>
<b>Schedule:</b><b> Part‑time | 24 hours per week</b></h3><div><b>
About IQVIA</b></div><div>
IQVIA is a global leader in advanced analytics, technology solutions, and clinical research services. We partner with leading pharmaceutical, biotechnology, and medical device organizations to accelerate clinical development and improve patient outcomes. By combining deep scientific expertise with innovative technologies, we deliver high‑quality data and insights that shape the future of healthcare.</div><div><b>
About the Role</b></div><div>
IQVIA is seeking a <b>highly experienced Clinical Research Coordinator (CRC)</b> to support the conduct of clinical research studies under the direction of a Principal Investigator. This role is hands‑on and patient‑facing, requiring strong clinical research expertise, the ability to manage multiple protocols, and a commitment to patient safety, regulatory compliance, and data integrity.</div><div>
The ideal candidate brings demonstrated experience leading study activities, coordinating visits, and supporting regulatory requirements in a fast‑paced clinical research environment.</div><div><b>
Key Responsibilities</b></div><ul><li><div>
Conduct clinical research visits and procedures, including ECGs, vital signs, and biological sample collection</div></li><li><div>
Coordinate day‑to‑day execution of multiple clinical research protocols simultaneously</div></li><li><div>
Ensure strict adherence to study protocols, Good Clinical Practice (GCP), and applicable regulatory requirements</div></li><li><div>
Prepare study materials, organize equipment, and manage logistical planning for study visits</div></li><li><div>
Recruit, screen, consent, and orient study participants while ensuring safety and ethical conduct</div></li><li><div>
Accurately document clinical data in case report forms (CRFs) and electronic data capture (EDC) systems</div></li><li><div>
Collaborate with investigators, monitors, and sponsors to resolve queries and maintain data quality</div></li><li><div>
Provide regulatory support, including maintenance of essential documents and audit readiness</div></li><li><div>
Serve as a patient advocate and maintain a safe clinical environment in accordance with Health &amp; Safety policies</div></li></ul><div><b>
Required Qualifications</b></div><ul><li><div>
Bachelor&rsquo;s degree preferred or an equivalent combination of education and relevant experience</div></li><li><div><b>
Significant experience as a Clinical Research Coordinator, including prior responsibility as a Lead CRC managing multiple protocols concurrently</b></div></li><li><div><b>
Demonstrated experience conducting study visits independently and providing regulatory support</b></div></li><li><div>
Minimum of 1+ years of clinical research experience (additional experience strongly preferred)</div></li><li><div>
Strong working knowledge of clinical trial operations, GCP, and medical terminology</div></li><li><div>
Proficiency in EDC systems, data entry, and query resolution</div></li><li><div>
High attention to detail with the ability to build effective working relationships across cross‑functional teams</div></li><li><div>
Experience in <b>Neurology and/or Pediatrics is a plus</b>, but not required</div></li></ul><div><b>
Why Join IQVIA?</b></div><ul><li><div>
Be part of a globally recognized clinical research organization</div></li><li><div>
Work on meaningful studies that improve patient outcomes</div></li><li><div>
Collaborate with experienced investigators and research professionals</div></li><li><div>
Gain exposure to diverse protocols and therapeutic areas</div></li></ul><div><b><i>
Note: </i></b><i>This position is not eligible for sponsorship</i></div><div>
#LI-CES and #LI-DNP #LI-HCP #remote</div></div><div>
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com</div><div>
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe</div><div>
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.</div>
The potential base pay range for this role is $35.00-$42.00 per hour. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.</div>

Clinical Research Coordinator - New York, NY

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:</li>
<li>Building:</li>
<li>Salary Range: $66,300-$68,000</li>
</ul><div><i>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.</i></div><br>
<div></div>
<p></p>
<p>Position Summary</p>
<div>
<p>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.</p>
</div>
<p></p><p>Responsibilities</p>
<p>
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.</p>
<p>
Responsibilities include, but are not limited to:</p>
<ul>
<li><b>GENERAL STUDY MANAGEMENT</b>
<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><b>PATIENT MANAGEMENT</b><br>
<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><b>DATA MANAGEMENT</b>
<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><b>OTHER</b>
<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><p></p><p>Minimum Qualifications</p>
<ul>
<li>Bachelor&rsquo;s degree or equivalent in education and/or experience.</li>
</ul>
<p></p><p>Preferred Qualifications</p>
<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>
<p></p><p>Equal Opportunity Employer / Disability / Veteran</p>
<p>
Columbia University is committed to the hiring of qualified local residents.</p></div>

Clinical Research Coordinator I

Columbia University Irving Medical Center

<div>
 Grade 103
 <br/>
 <br/>
 <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
   <br/>
   <br/>
  </li>
 </ul>
 <em>
  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.
  <br/>
  <br/>
 </em>
 Position Summary
 <br/>
 <br/>
 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.
 <br/>
 <br/>
 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.
 <br/>
 <br/>
 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.
 <br/>
 <br/>
 <strong>
  Responsibilities
  <br/>
  <br/>
 </strong>
 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.
 <br/>
 <br/>
 <strong>
  Responsibilities Include, But Are Not Limited To
  <br/>
  <br/>
 </strong>
 <em>
  GENERAL STUDY MANAGEMENT
  <br/>
  <br/>
 </em>
 <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.
   <br/>
   <br/>
  </li>
 </ul>
 <em>
  PATIENT MANAGEMENT
  <br/>
  <br/>
 </em>
 <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.
   <br/>
   <br/>
  </li>
 </ul>
 <em>
  DATA MANAGEMENT
  <br/>
  <br/>
 </em>
 <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.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Other
  <br/>
  <br/>
 </strong>
 <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.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Minimum Qualifications
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Bachelor&rsquo;s degree or equivalent in education and/or experience.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Preferred Qualifications
  <br/>
  <br/>
 </strong>
 <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.
   <br/>
   <br/>
  </li>
 </ul>
 Equal Opportunity Employer / Disability / Veteran
 <br/>
 <br/>
 Columbia University is committed to the hiring of qualified local residents.
</div>


Mount Sinai Health System

<div><b>Description</b><p>
The Clinical Research Coordinator assists in the daily activities of clinical research studies, obtains informed consent; collects, maintains and organizes study information. Assists in preparing grant applications and documents (for e.g., Institutional Review Board, Grants and Contracts Office).</p><p>
The Clinical Trials Office in the Division of Medical Genetics seeks a Clinical Research Coordinator to join a team of investigators, genetic counselors and research staff working in cutting-edge research for rare genetic conditions. Under the supervision of principal investigators and the Clinical Trials Office administration, the Clinical Research Coordinator will report to the Associate Director of the CTO.</p><b>
Responsibilities</b><ul><li>
Educating patients regarding study requirements and obtaining informed consent from research participants</li><li>
Collection of study data, data entry, and maintenance of research databases</li><li>
Assisting in the collection, analysis and review of experimental data for publication and presentation.</li><li>
Recruitment of participants in clinical research studies</li><li>
Preparation and submission of research protocols and other regulatory documents to Institutional Review Boards</li><li>
Maintenance of source documents and subject files in accordance with Mount Sinai policies and procedures, ensuring accurate, confidential, and complete compilation of data</li><li>
Collection and shipment of biospecimens</li><li>
Preparation for site visits from clinical research monitors, auditors, and regulatory agencies</li><li>
Serving as a liaison between patients, clinical research organizations, sponsors, grants team, Institutional Review Boards, and the research team</li><li>
Attending research team meetings and conferences as needed</li><li>
Miscellaneous duties as assigned</li></ul><b>
Qualifications</b><ul><li>
Bachelors or Masters degree in Science or closely related field.</li><li>
No experience required. One year of research experience preferred.</li><li>
Strong verbal, written, and interpersonal skills and the ability to interact with patients and members of diverse populations</li><li>
Organizational, problem solving, and analytical skills</li><li>
Ability to work independently and with careful attention to detail</li><li>
Experience working with clinical trial management systems including OnCore a plus</li><li>
Experience working with electronic medical records systems including Epic a plus</li><li>
Experience working with electronic regulatory binders a plus</li></ul><p></p><b><br>
Employer Description</b><p><b>
Strength through Unity and Inclusion</b></p><br>
<p>
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.</p><br>
<p>
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.</p><br>
<p><b>
About the Mount Sinai Health System:</b></p><br>
<p>
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.</p><br>
<p><b>
Equal Opportunity Employer</b></p><br>
<p>
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.</p><br>
<p><b>
Compensation</b></p><p>
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 $58661 - $73530 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.</p></div>

Clinical Research Coordinator I- Genetics Clinical Trials

<div><ul><li>Job Type: Officer of Administration</li>
<li>Regular/Temporary: Regular</li>
<li>Hours Per Week: 35</li>
<li>Salary Range: $69,500 - $72,500 Annual</li>
</ul><div><i>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.</i></div><br>
<div></div>
<p></p>
<p>Position Summary</p>
<p>
The Clinical Research Coordinator I is an intermediate level position that provides independent study coordination for simple and moderately complex clinical research studies such as registries, retrospective data reviews, studies in long-term follow-up, and other non-interventional studies or under supervision provides study coordination for moderate complexity to high complexity clinical trials with supervision such as such as EFS and pivotal IDE/IND studies. Responsible for consent, screening for eligibility and identification of AES under minimal supervision. Completes subject follow ups, source documentation, device accountability and preparing for monitoring visits independently. The CRC I should be capable of independently performing tasks, making decisions, and consistently delivering accurate and high-quality work. They possess a moderate level of expertise across various skills and abilities within their function on the research team.</p>
<p></p>
<p>Responsibilities</p>
<p>
CLINICAL COORDINATION</p>
<ul>
<li>May create a recruitment plan that addresses the needs of the study population.</li>
<li>Demonstrates ability to screen participants for study eligibility &amp; enroll with accuracy in various databases.</li>
<li>Demonstrates ability to find and utilize information from EMR and databases/CTMS/EDC.</li>
<li>Demonstrates understanding of protocol elements/requirements and demonstrate the ability to execute study procedures.</li>
<li>Understands protocol structure and how to interpret study requirements to ensure study compliance.</li>
<li>Understands proper documentation techniques as outlined in the ICH-GCP guidelines.</li>
<li>May complete P-card reimbursement to patients.</li>
<li>Processes subject visit billing and tracking of invoiceable items.</li>
<li>Schedules, assists with preparation, and attends study initiation meetings, audits, and monitor visits.</li>
<li>Obtains informed consent from subject.</li>
<li>Conducts all startup, active implementation, and closeout activities</li>
<li>Assesses studies for execution and troubleshoots potential implementation issues.</li>
<li>Demonstrates the ability to anticipate and mitigate the potential for protocol non-compliance.</li>
<li>Triages subject concerns and issues appropriately.</li>
<li>Performs moderately complex study procedures with accuracy.</li>
</ul>
<p>DATA COORDINATION</p>
<ul>
<li>Enters data to complete forms (CRFs) on paper, databases, or EDCs.</li>
<li>Demonstrates ability to resolve moderately complex queries (e.g., data error changed numerous values in EDC).</li>
<li>Explains how to utilize information from the EMR and study databases.</li>
<li>Demonstrates the ability to complete moderately complex data collection during study visits.</li>
<li>Demonstrates the ability to document data in accordance with ALCOA-C principles.</li>
<li>Administers surveys and questionnaires.</li>
<li>Demonstrates ability to perform concomitant medications abstraction.</li>
<li>Builds patient research study charts.</li>
<li>Assists with collection of external medical records, CLIAs, CAPs, and radiology CDs as assigned.</li>
<li>Contributes to the development of processes and tools to capture data in accordance with ALCOA- C principles.</li>
<li>Demonstrates the ability to create CRFs, study documents, and tools.</li>
<li>Knowledge of the elements and development of an effective corrective and preventive action plan (CAPA).</li>
<li>Creates and manage databases.</li>
</ul>
<p>REGULATORY COORDINATION</p>
<ul>
<li>Uses proper documentation techniques as outlined in the ICH-GCP guidelines.</li>
<li>Demonstrates ability to maintain essential regulatory documents as outlined in the ICH-GCP guidelines.</li>
<li>Assists Regulatory manager in submission and management of IRB applications.</li>
<li>Demonstrates ability to identify Adverse Events (AEs), Serious Adverse Events (SAEs), and UP and understands how to report appropriately.</li>
<li>Demonstrates ability to manage increasing levels of protocol complexity or volume efficiently.</li>
<li>Demonstrates an understanding of the elements of subject safety, related documentation, and reporting.</li>
<li>Recognizes situations requiring prompt escalation and demonstrates actions to minimize risks.</li>
<li>Demonstrates an understanding of Investigational products development process and applies key regulatory requirements to control these processes.</li>
</ul>
<p>ADMINISTRATIVE RESPONSIBILITIES</p>
<ul>
<li>Provides other administrative support for study activity including scanning, filing, etc. of research documents; managing organization of research kits.</li>
<li>Communicates with study participants such as sending study correspondence via mail or email.</li>
<li>Schedules subjects for research visits and FU appointments.</li>
<li>Checks study calendar for completion of study procedures.</li>
<li>Manages study supply inventory.</li>
<li>Utilizes documents and systems to track recruitment and retention of participants.</li>
<li>Participates in regular study meetings.</li>
<li>Provides logistic and regulation guidance to entry level employees on Federal and University policy and guidelines.</li>
<li>Acts as a liaison or point of contact between investigators, research teams, sponsors, other universities, cooperative groups, other internal and external departments to get questions answered and issues resolve.</li>
</ul>
<p>TRAINING</p>
<ul>
<li>Gains appropriate training &amp; knowledge of EMR, CTMS, EDC, databases, etc. as assigned.</li>
<li>Attends and participates in all training assigned to this level including CITI, GCP, HIPAA.</li>
<li>Understands the disease process per program.</li>
<li>Participates in trainings specifically for maintaining certification as a Clinical Research Professional.</li>
<li>Provides training and mentorship for CRC clinical research staff on communication and teamwork best practices.</li>
<li>Attends and participates in all training assigned to this level.</li>
</ul>
<p>COMPETENCY</p>
<ul>
<li>Functional Knowledge: Demonstrates a strong understanding of the research subject matter specific to their role on the team.</li>
<li>Problem Solving: Analyzes moderately complex situations and apply education, experience, judgment, and precedent to identify and implement effective solutions.</li>
<li>Decision Making/Autonomy: Carries out research projects per guidelines and regulation with limited supervision, collaborating both independently and with the Principal Investigator (PI) and Clinical Research Manager. Requires a moderate degree of initiative and independent judgment.</li>
<li>Communication Skills: Summarizes and explains research information to others effectively.</li>
</ul>
<p>Perform other responsibilities as assigned.</p>
<p>
Please note that specific responsibilities may vary based on the needs of your unit or team. Certain units may require a greater focus on clinical, data, regulatory, or other specific needs. The role of Clinical Research Coordinator may support task-oriented requirements within the broader context of clinical research coordination.</p>
<p></p>
<p>Minimum Qualifications</p>
<ul>
<li>Bachelor's degree or equivalent in education and/or experience, plus 3 years of experience.</li>
<li>Mastered competency of the specific responsibilities and duties from the CRC.</li>
<li>Technical competency in areas such as regulatory requirements, data management, and study documentation.</li>
<li>Experience in managing study-specific procedures, including patient eligibility screening, informed consent, and adverse event reporting.</li>
</ul>
<p></p><p>Other Requirements</p>
<ul>
<li>Participation in the medical surveillance program:
<ul><li>Contact with patients and/or human research subjects.</li>
</ul></li><li>Successful completion of applicable compliance and systems training requirements.</li>
</ul>
<p></p><p>Equal Opportunity Employer / Disability / Veteran</p>
<p>
Columbia University is committed to the hiring of qualified local residents.</p></div>

Clinical Research Coordinator I - Cardiology

<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><i>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.</i></div><br>
<div></div>
<p></p>
<p>Position Summary</p>
<p>
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.</p>
<p><i>
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 </i>Health and Welfare<i>, </i>Employee Assistance<i>, </i>Tuition Programs<i>, and </i>Retirement Benefits<i>.</i></p>
<p></p>
<p>Responsibilities</p>
<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>
<p></p><p>Minimum Qualifications</p>
<ul>
<li>Bachelor&rsquo;s degree or equivalent in education and experience required.</li>
</ul>
<p></p><p>Preferred Qualifications</p>
<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>
<p></p><p>Other Requirements</p>
<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><p></p><p>Equal Opportunity Employer / Disability / Veteran</p>
<p>
Columbia University is committed to the hiring of qualified local residents.</p></div>

Clinical Research Coordinator

<div><ul><li>Job Type: Officer of Administration</li>
<li>Regular/Temporary: Regular</li>
<li>Hours Per Week: 35</li>
<li>Salary Range: $66,300.00 - $68,300.00 Annual</li>
</ul><div><i>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.</i></div><br>
<div></div>
<p></p>
<p>Position Summary:</p>
<p>
This entry-level position provides coordination and administrative support for clinical research projects, specifically in Cardiology, under supervision. Responsibilities include data entry in EDC, Redcap, and CTMS, resolving simple queries, extracting data from medical records for study forms, and maintaining research records such as screening/enrollment logs and electronic regulatory files. Additionally, the role may involve participant recruitment, obtaining consent, device accountability, follow-ups, and monitoring visits under supervision.</p>
<p></p>
<p>Responsibilities</p>
<p><b>
Clinical Coordination</b></p>
<ul>
<li>Screen participants for study eligibility and enroll them accurately in various databases.</li>
<li>Utilize information from EMR, databases, CTMS, and EDC.</li>
<li>Understand and execute study protocol requirements and procedures.</li>
<li>Interpret study protocols to ensure compliance.</li>
<li>Maintain proper documentation as per ICH-GCP guidelines.</li>
<li>Complete P-card reimbursement for patients.</li>
<li>Track subject visit billing and invoiceable items.</li>
<li>Assist in study initiation meetings, audits, and monitoring visits.</li>
<li>Perform simple study procedures accurately.</li>
<li>May obtain informed consent from participants.</li>
</ul>
<p><b>Data Coordination</b></p>
<ul>
<li>Enter data in CRFs, databases, or EDCs.</li>
<li>Resolve simple data queries.</li>
<li>Extract and utilize information from EMR and study databases.</li>
<li>Complete basic data collection during study visits.</li>
<li>Document data according to ALCOA-C principles.</li>
<li>Administer surveys and questionnaires.</li>
<li>Perform concomitant medication abstraction.</li>
<li>Build patient research study charts.</li>
<li>Collect external medical records, CLIAs, CAPs, and radiology CDs as assigned.</li>
</ul>
<p><b>Regulatory Coordination</b></p>
<ul>
<li>Maintain documentation following ICH-GCP guidelines.</li>
<li>Work with regulatory support to collect essential documents and maintain regulatory binders (CVs, MD licenses, lab certifications, IRB rosters, lab norms, etc.).</li>
<li>Assist the Regulatory Manager in IRB submissions and management.</li>
<li>Identify and report Adverse Events (AEs), Serious Adverse Events (SAEs), and other safety concerns appropriately.</li>
</ul>
<p><b>Administrative Support</b></p>
<ul>
<li>Provide administrative support, including scanning, filing, and organizing research documents.</li>
<li>Manage research kit organization.</li>
<li>Communicate with study participants via mail or email.</li>
<li>Schedule research visits and follow-up appointments.</li>
<li>Monitor study calendars for procedure completion.</li>
<li>Manage study supply inventory.</li>
<li>Track participant recruitment and retention.</li>
<li>Participate in regular study meetings.</li>
<li>Process payments and reimbursements for participants.</li>
<li>Provide logistic and regulatory guidance on Investigator-Initiated Studies to ensure compliance with university and federal guidelines.</li>
<li>Act as a liaison between investigators, research teams, sponsors, universities, and internal/external departments to resolve issues.</li>
</ul>
<p><b>Training</b></p>
<ul>
<li>Complete required training in CITI, GCP, and HIPAA.</li>
<li>Gain knowledge of EMR, CTMS, EDC, and other relevant databases.</li>
<li>Learn and apply available technology and systems to job responsibilities.</li>
<li>Acquire disease-specific knowledge relevant to assigned programs.</li>
<li>Attend and actively participate in all assigned training.</li>
</ul>
<p><b>Competencies</b></p>
<ul>
<li>Functional Knowledge &ndash; Understanding of the general research process, medical terminology, and clinical research coordination in a large healthcare setting. Familiarity with university policies and procedures is preferred.</li>
<li>Problem-Solving &ndash; Utilize analytical skills to address simple issues following guidelines and protocols.</li>
<li>Decision-Making &amp; Autonomy &ndash; Work under direct supervision to ensure tasks comply with regulations and study requirements.</li>
<li>Communication Skills &ndash; Effectively share information and confirm data accuracy.</li>
</ul>
<p>Perform other responsibilities as needed.</p>
<p></p>
<p>Minimum Qualifications</p>
<ul>
<li>Bachelor&rsquo;s degree or equivalent in education, training, and experience.</li>
</ul>
<p></p><p>Preferred Qualifications</p>
<ul>
<li>At least two years of related experience</li>
<li>Knowledge of university policies and procedures</li>
<li>Basic knowledge and understanding of clinical research processes, regulations, and the role of a Clinical Research Coordinator (CRC)</li>
</ul>
<p></p><p>Other Requirements</p>
<ul>
<li>Participation in the medical surveillance program
<ul><li>Contact with patients and/or human research subjects</li>
<li>Potential bloodborne pathogen exposure</li>
</ul></li><li>Successful completion of applicable compliance and systems training requirements</li>
</ul>
<p></p><p>Equal Opportunity Employer / Disability / Veteran</p>
<p>
Columbia University is committed to the hiring of qualified local residents.</p></div>

Clinical Research Coordinator - Cardiology

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