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associate researcher ii - genetics (sebra lab) Jobs in New York

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clinical research officer

The Rockefeller University

<div>
 Organization Overview
 
 
 The new Diagnostic and Treatment Center (D&amp;TC) will be named the &ldquo;Rockefeller University Clinical Research Center&rdquo; (RCRC). The University remains committed to its mission of improving the understanding of science for the benefit of humanity through both clinical and basic research in a diverse range of biological and biomedical issues. The outpatient D&amp;TC reflects the evolution in clinical research to outpatient studies.
 
 
 
 Overview
 
 
 
 Reporting to the Executive Director, the Clinical Research Officer (CRO) leads participant-focused research practices and is responsible for developing, implementing, and evaluating strategies to enhance participant engagement, equitable recruitment, high-quality informed consent, and the overall research experience within an outpatient diagnostic and treatment environment.
 
 
 Working in close partnership with medical, regulatory, and operational leadership, the CRO ensures that participant-centered principles are meaningfully integrated into the design and conduct of clinical research. The CRO also serves as a senior advisor on the design and implementation of clinical research protocols at the Diagnostic and Treatment Center (D&amp;TC).
 
 
 
 Responsibilities
 
 
 
 The Clinical Research Officer shapes and advances participant-focused research practices through strategic leadership and supervision of participant engagement initiatives. The CRO enhances recruitment effectiveness, participant experience, ethical rigor, and equitable access to research participation. The role strengthens institutional research quality by ensuring participant-centered principles are embedded in the operational and strategic framework of the D&amp;TC.
 
 
 Position duties and responsibilities include, but are not limited to, the following:
 
 
 <ul>
 <li>
 Develops and leads the implementation of participant-focused research practices.
 </li>
 <li>
 Establishes best practices to enhance informed consent processes, participant communication, recruitment approaches, and research experience standards.
 </li>
 <li>
 Integrates participant-centered principles into outpatient clinical research workflows and operational procedures.
 </li>
 <li>
 Oversees development and evaluation of participant experience metrics and quality improvement initiatives. Directs recruitment strategy development in collaboration with investigators and clinical operations.
 </li>
 <li>
 Promotes equitable access to research participation and supports inclusive recruitment practices.
 </li>
 <li>
 Provides oversight and guidance to the Participant Engagement and Recruitment Specialist. Advises investigators and leadership on participant-centered considerations in clinical trial design and implementation within a Diagnostic and Treatment Center model.
 </li>
 <li>
 Assesses protocol feasibility related to recruitment, retention, and participant burden. Translates participant feedback and operational insights into continuous improvements in research processes.
 </li>
 <li>
 Partners with medical, regulatory, and operational leadership to ensure alignment with Good Clinical Practice (GCP), FDA, IRB, NIH, and institutional standards related to participant protection.
 </li>
 <li>
 Strengthens institutional practices related to informed consent quality, confidentiality, and ethical conduct of research. Contributes to audit-readiness and continuous compliance improvement efforts.
 </li>
 <li>
 Other duties and special projects as assigned.
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 
 REQUIRED QUALIFICATIONS:
 
 
 
 <ul>
 <li>
 A bachelor&rsquo;s degree in life sciences, health sciences, nursing, medicine, pharmacology, or a related field is required.
 </li>
 <li>
 Minimum of five (5) years of research experience in clinical or translational research, including significant experience in human subjects research.
 </li>
 <li>
 Position requires in-person, onsite presence.
 </li>
 <li>
 Demonstrated ability to supervise research compliance initiatives and implement participant-focused research practices.
 </li>
 <li>
 Prior experience advising on clinical trial design and operational implementation in regulated research environments. Strong knowledge of Good Clinical Practice (GCP), FDA, and IRB regulations. Ability to integrate participant-centered initiatives into operational research workflows.
 </li>
 <li>
 Familiarity with ethical standards in human research (informed consent, confidentiality). Ability to navigate challenges and make informed, ethical decisions.
 </li>
 <li>
 Must have a passion for excellent customer service and commitment to exceptional quality. Strong interpersonal, written, and oral communication skills, along with attention to detail, are essential. Initiative and self-motivation are critical.
 
 
 </li>
 </ul>
 
 Preferred Qualifications
 
 
 
 <ul>
 <li>
 Advanced degree preferred.
 </li>
 <li>
 Advanced methodological expertise in clinical trial design and implementation.
 </li>
 <li>
 Prior experience in an academic or research institution is strongly preferred.
 
 
 </li>
 </ul>
 The Rockefeller University is an equal opportunity employer &ndash; veterans/individuals with disabilities. Qualified applicants will receive consideration for employment without regard to characteristics protected by applicable local, state, or federal law, including but not limited to disability and protected veteran status.
 
 
 The salary of the finalist selected for this role will be set based on various factors, including but not limited to organizational budgets, qualifications, experience, education, licenses, specialty, and training. The hiring range provided represents The Rockefeller University's good faith and reasonable estimate of the range of possible compensation at the time of posting.
 
 
 Compensation Range: Min
 
 
 USD $130,000.00/Yr.
 
 
 Compensation Range: Max
 
 
 USD $150,000.00/Yr.
</div>

Clinical Research Officer | Diagnostic & Treatment Center

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 - $ 66,300</li>
</ul><div>The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.</div> 
<div></div>

Position Summary

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.

Our staff is pivotal in facilitating and advancing these cutting-edge research endeavors.

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.

A background in research or health administration is a plus, but not a requirement.

(Grant Funded)

Responsibilities
<div>
Clinical Trials Coordination</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>Collaboration &amp; Stakeholder Management</div>
<ul><li>Ensure timely notification and/or communication between the Principal Investigator and compliance offices and study sponsors.</li>
</ul><div>Continuous Improvement</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>

Minimum Qualifications
<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>

Preferred Qualifications
<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>

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.

We are continuously seeking to recruit individuals who will enhance the diversity of our workplace and the effectiveness of our organization. 


Equal Opportunity Employer / Disability / Veteran

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

Clinical Research Coord I

Columbia University Irving Medical Center

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

Clinical Research Coordinator I

<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>The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.</div> 
<div></div>

Position Summary

The 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.

Responsibilities

CLINICAL COORDINATION
<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>
DATA COORDINATION
<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>
REGULATORY COORDINATION
<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>
ADMINISTRATIVE RESPONSIBILITIES
<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>
TRAINING
<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>
COMPETENCY
<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>
Perform other responsibilities as assigned.

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.

Minimum Qualifications
<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>
Other Requirements
<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>
Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.</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: $69,500 - $72,500 Annual</li>
</ul><div>The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.</div>

Position Summary

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.

Responsibilities

CLINICAL COORDINATION
<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>
DATA COORDINATION
<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>
REGULATORY COORDINATION
<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>
ADMINISTRATIVE RESPONSIBILITIES
<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>
TRAINING
<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>
COMPETENCY
<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>
Perform other responsibilities as assigned.

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.

Minimum Qualifications
<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>
Other Requirements
<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>
Equal Opportunity Employer / Disability / Veteran

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

Clinical Research Coordinator I - Cardiology (CARE)

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

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

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

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

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

<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>The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.</div> 
<div></div>

Position Summary

The candidate 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.

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.

Responsibilities
<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>
Minimum Qualifications
<ul>
<li>Bachelor's degree or equivalent in education and experience, plus three years of related experience</li>
</ul>
Other Requirements
<ul>
<li>This is an on-site position</li>
</ul>
Equal Opportunity Employer / Disability / Veteran

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

Clinical Research Coordinator II

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342 clinical research officer jobs In New York

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