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associate researcher i-pathology molecular and cell based medicine Jobs in New York

associate researcher i-pathology, molecular and cell based medicine Jobs in New York

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>


Clinical Research Coordinator I

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>
<p>
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.</p>
<div>
<p>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.</p>
<p>
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.</p>
</div>
<p></p><p>Responsibilities</p>
<p>
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.</p>
<p>
Responsibilities include, but are not limited to:</p>
<p><i>
GENERAL STUDY MANAGEMENT</i></p>
<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>
<p><i>PATIENT MANAGEMENT</i></p>
<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>
<p><i>DATA MANAGEMENT</i></p>
<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>
<p><i>OTHER</i></p>
<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>
<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>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>
<p></p><p>Equal Opportunity Employer / Disability / Veteran</p>
<p>
Columbia University is committed to the hiring of qualified local residents.</p></div>

<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>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-$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>

<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>
<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 (CARE)

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><b><br>
Responsibilities</b><ul><li>
Collects and records study data. Inputs all information into database.</li><li>
Obtains informed consent under minimal supervision of the investigator(s) and educates participants regarding study requirements.</li><li>
Assists in the activities related to clinical research studies including but not limited to: answering phone calls, screening participants for eligibility, registering subjects with sponsoring agency, administering lifestyle questionnaires.</li><li>
Assists in preparing grant applications, IRB/GCO for submission and filings.</li><li>
Maintains source documents and subject files in accordance with hospital procedures. Ensures accurate and complete compilation of subject data through chart reviews.</li><li>
Secures, delivers and ships clinical specimens as required by the protocol.</li><li>
Prepares for monitoring visits.</li><li>
Performs other related duties.</li></ul><br>
<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></ul><p></p><b><br>
Employer Description</b><p><b>
Strength through Unity and Inclusion</b></p>
<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>
<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>
<p><b>
About the Mount Sinai Health System:</b></p>
<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>
<p><b>
Equal Opportunity Employer</b></p>
<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><p><b><br>
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- Cardiology

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Clinical Research Coordinator I

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Clinical Research Coordinator I

Clinical Research Coordinator I - Cardiology (CARE)

Clinical Research Coordinator I- Cardiology