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clinical research coordinator i

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clinical research manager

clinical research nurse coordinator

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>


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

<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 - $80,000 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>
<div>
We are an innovative research center looking for highly organized, detail-oriented, and enthusiastic candidates to support the patient-oriented research portfolio of the Center. Under the direction of the Principal Investigator, the Clinical Research Coordinator I will assist</div>
<div>with participant recruitment, onboarding, scheduling, and data collection for research studies. This position offers a unique opportunity to advance participant care while contributing to cutting-edge research on innovative cardiac rehabilitation (CR) models. The candidate can expect to represent the Center by interacting with a wide variety of multi-disciplinary personnel at our Center, including study PIs, research coordinators, data team personnel and administration, as well as external clinic representatives and key collaborators. The candidate must be able to demonstrate flexibility in workload and work hours to meet critical deadlines. Further, we anticipate developing new studies and research directions, so ideal candidates will be able to adapt to a fast-paced environment with evolving responsibilities, workloads and work schedules.</div>
<div></div>
<div>At CBCH our goal is to work together as a collective (faculty, admin, and staff) to advance shared values and goals.</div>
<div></div>
<div>Candidates should anticipate the need to work both on site (in the research office and in clinical spaces), as well as remotely. Candidates should anticipate the need for flexible work hours to attain study goals and grant milestones. Candidates may expect work hours to be scheduled between 7:00 am and 7:30 pm and occasionally on weekends, varying from week-to-week depending upon study and grant needs. Candidates should be comfortable in a team-oriented, collaborative work culture with frequent interactions with study participants, collaborating investigators, and clinic personnel.</div>
<p></p>
<p>Responsibilities</p>
<ul>
<li><div>Assist with participant recruitment, eligibility screening, and scheduling.</div>
</li><li><div>Conduct home-based CR sessions via telehealth, including safety checks, RPM integration, exercise supervision, and maintain appropriate documentation of patient care in Epic/MyChart.</div>
</li><li><div>Lead participant onboarding sessions, providing training on devices, exercise equipment, vital sign measurements, apps, RPE scale, and safety protocols.</div>
</li><li><div>Recognize contraindications and abnormal participant responses to exercise.</div>
</li><li><div>Respond appropriately to all situations, including exercise cessation and referral to medical professionals.</div>
</li><li><div>Collect and manage study-related data including session adherence, vital signs, and patient-reported measures.</div>
</li><li><div>Collaborate with the study team to identify and report significant observations.</div>
</li><li><div>Ensure fidelity to study protocol while integrating with standard-of-care CR workflows.</div>
</li><li><div>Perform other duties as assigned.</div>
</li>
</ul><p></p><p>Minimum Qualifications</p>
<ul>
<li><div>Master&rsquo;s degree in Clinical Exercise Physiology or related field plus 600 hours of clinical experience or equivalent in education, training and experience.</div>
</li><li><div>Strong communication and participant education skills.</div>
</li><li><div>Proficiency in exercise testing, ECG interpretation, and risk stratification.</div>
</li><li><div>Current CPR/BLS (Professional Rescuer) certification (or obtained prior to start date).</div>
</li>
</ul><p></p><p>Preferred Qualifications</p>
<ul>
<li><div>ACSM Clinical Exercise Physiologist (CEP) or AACVPR Certified Cardiac Rehabilitation</div>
<div>Professional (CCRP) credential.</div>
</li><li><div>Advanced experience with Epic/MyChart and telehealth delivery platforms.</div>
</li><li><div>Prior experience in cardiac rehabilitation or secondary prevention.</div>
</li><li><div>Research experience, including participant recruitment and data collection.</div>
</li>
</ul><p></p><p>Other Requirements</p>
<ul>
<li><div>Strong interpersonal skills, as well as oral and written communication skills, including a record of work in research settings (e.g., presentations/publications).</div>
</li><li><div>Experienced in participant-oriented, clinical research.</div>
</li><li><div>Must be highly organized, with excellent attention to detail and follow-up skills.</div>
</li><li><div>High technical competence related to the use of research devices.</div>
</li><li><div>Must be able to work independently, as well as perform as part of a team.</div>
</li><li><div>Must demonstrate flexibility and willingness to adjust schedule to meet project demands and critical deadlines, including availability for early morning, late evening or potentially weekend hours.</div>
</li><li><div>Strong commitment to equity, diversity, and inclusion.</div>
</li><li>Participation in medical surveillance program:
<ul><li>Contact with patients and/or human research subjects</li>
</ul></li><li>Must successfully complete 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 - CBCH

<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 - $80,000.00</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 candidate should be highly motivated, interested in pediatric diseases, have excellent interpersonal skills and an interest in academic research. We are looking for someone who can establish good rapport with children, adults and families as well as the clinical, research, and administrative teams. We emphasize the importance of team unity as central to our success.</p>
<p>
The candidate will report to the Principal Investigator (PI), Dr. Chiriboga, and the research supervisor and will be responsible for subject recruitment and the conduct of clinical studies. Additional responsibilities include maintaining compliance with existing policies and procedures at Columbia University, the IRB, and the CTSA, that relate to clinical research.</p>
<p></p>
<p>Responsibilities</p>
<ul>
<li>Participation in pre-study, initiation, monitoring and close out visits</li>
<li>Submission of FDA IND studies and PI initiated research protocols to other regulatory institutions in US</li>
<li>Implementation of clinical trials from initiation, including assistance with the development of standard operating procedures and case report forms</li>
<li>Recruitment and coordination of the clinical trial participants covering informed consent, screening, and inclusion of the subjects adhering to safety and compliance issues.</li>
<li>Coordination and management of the clinical trial, communication with sponsor and monitors, visit coordination, sample acquisition and processing.</li>
<li>Reporting and documentation of protocol deviations and exemptions as well as development and implementation of corrective action plans for review by the Principal Investigator as needed</li>
<li>Data collection and management, collection of source documents, registration, and management of adverse events, filing and archiving, managing monitoring visits and managing queries.</li>
<li>Close-out of the clinical trial, contributing to manuscripts, audit preparation, trial completion, and communication with authorities. Other responsibilities include assisting with the final study report and completing financial obligations.</li>
<li>Other duties assigned as needed by the division.</li>
</ul>
<p></p><p>Minimum Qualifications</p>
<ul>
<li>Bachelor's degree or equivalent in education and experience, plus three years of related experience</li>
</ul>
<p></p><p>Other Requirements</p>
<ul>
<li>This is an on-site position</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 II

<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 - $ 66,300</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>
Columbia University Irving Medical Center (CUIMC) provides global leadership in scientific research, health and medical education, and patient care. Home to approximately 4,472 students and over 3,000 part-time and full-time faculty members, the health sciences campus includes the four professional schools&mdash;the Vagelos College of Physicians and Surgeons, the College of Dental Medicine, the School of Nursing, and the Mailman School of Public Health.</p>
<p>
Our staff is pivotal in facilitating and advancing these cutting-edge research endeavors.</p>
<p>
Clinical Research Coordinators (CRCs) are key members of research teams at Columbia. They collaborate closely with Principal Investigators (PIs) managing and overseeing the various aspects of clinical trials and research. Key responsibilities and tasks include study coordination, data collection, regulatory compliance, and serving as a Research liaison. The ideal candidate would need strong communication, organizational, and interpersonal skills.</p>
<p>
A background in research or health administration is a plus, but not a requirement.</p>
<p>
(Grant Funded)</p>
<p></p>
<p>Responsibilities</p>
<div><b>
Clinical Trials Coordination</b></div>
<div></div>
<ul><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>Maintain accurate and complete clinical research files, which may include administering questionnaires and maintenance of case report forms (CRFs)</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><li>Possess understanding and awareness of Corrective and Preventative Actions (CAPA).</li><li>Coordinate financial transactions related to the study including compensation to study subjects for their participation and helping them 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 inventor, requesting additional items as needed.</li><li>Assists in submission of closeout documents to applicable agencies and sponsoring parties in accordance with policies and procedures.</li><li>Performs all other duties as assigned.</li></ul>
<div></div>
<div><b>Collaboration &amp; Stakeholder Management</b></div>
<ul><li>Ensure timely notification and/or communication between the Principal Investigator and compliance offices and study sponsors.</li>
</ul><div><b>Continuous Improvement</b></div>
<ul><li>Participates in and/or supports assigned team projects and initiatives and escalates issues or potential barriers.</li><li>Keeps current on all organizational policies, goals, and initiatives.</li><li>Successfully completes all required university, systems, and department trainings.</li></ul>
<p></p>
<p>Minimum Qualifications</p>
<ul><li>Bachelor's Degree or equivalent in education, training, and experience</li><li>Must possess a 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 teams in a deadline driven, multi- tasking environment.</li><li>Strong commitment to fostering diversity and equity.</li><li>Working knowledge of Microsoft Office, including strong Excel skills.</li><li>Ability and willingness to learn new systems and programs.</li><li>Bi-lingual (Spanish and English or French English).</li></ul>
<p></p>
<p>Preferred Qualifications</p>
<ul><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 setting.</li><li>Experience with electronic medical records and/or research data entry, including REDCap and Qualtrics, iLab, or OpenSpeciman.</li><li>Knowledge of clinical research systems and processes, Good Clinical Practice (GCP) guidelines, HIPAA, IRB and other regulatory and compliance activities.</li><li>Phlebotomy certification.</li></ul>
<p></p>
<p>The Department of Obstetrics and Gynecology is dedicated to the goal of building a multicultural faculty and staff committed to teaching, working and serving in a diverse community, and strongly encourages applications from candidates of traditionally underrepresented backgrounds.</p>
<p>
We are continuously seeking to recruit individuals who will enhance the diversity of our workplace and the effectiveness of our organization.</p><br>
<p></p>
<p>
Equal Opportunity Employer / Disability / Veteran</p>
<p>
Columbia University is committed to the hiring of qualified local residents.</p></div>

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