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Clinical Research Coordinator jobs at Columbia University in the City of New York - 37 jobs

  • Bioethics Research Coordinator

    Columbia University In The City of New York 4.2company rating

    Clinical research coordinator job at Columbia University in the City of New York

    * Job Type: Officer of Administration * Regular/Temporary: Regular * Hours Per Week: 35 * Salary Range: $66,300 - $75,700 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 The Ethics Team at the Center for Precision Medicine and Genomics (CPMG) seeks a highly motivated Bioethics Research Coordinator to support NIH-funded, community-engaged studies focused on the ethical, legal, and social implications (ELSI) of genetics. This position offers a unique opportunity to contribute to cutting-edge bioethics research in a collaborative academic environment. The Coordinator will report to Dr. Maya Sabatello, Principal Investigator, and will work closely with faculty, staff, and community partners to implement research protocols and contribute to scholarly outputs. For more information about the CPMG, see ******************************************* Responsibilities Responsibilities include: * Conduct comprehensive literature reviews relevant to study aims. * Coordinate and conduct qualitative data collection (e.g., interviews), including participant recruitment. * Assist in the development of manuscripts, presentations, and other scholarly outputs. * Provide administrative support for research activities, including scheduling, documentation, and reporting. * Liaise with internal and external collaborators, including community partners. * Ensure compliance with IRB and NIH guidelines. * Perform other related duties as assigned. Minimum Qualifications * Bachelor's degree or equivalent in education, training, and experience. * Experience conducting empirical research, including interviews, coding, and data analysis. * Demonstrated familiarity with ELSI research. * Strong verbal and written communication skills. * Excellent organizational skills and attention to detail. * Ability to work independently and collaboratively in a fast-paced research environment. * Capacity to manage multiple priorities and meet deadlines. Preferred Qualifications * Master's degree in related field. * Bilingual proficiency in English and Spanish. * Experience developing professional presentations and academic manuscripts. * Familiarity with disability studies and inclusive research practices. Other Requirements * Successful completion of applicable compliance and systems training requirements. Equal Opportunity Employer / Disability / Veteran Columbia University is committed to the hiring of qualified local residents.
    $66.3k-75.7k yearly 3d ago
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  • Research Coordinator

    Columbia University In The City of New York 4.2company rating

    Clinical research coordinator job at Columbia University in the City of New York

    * Job Type: Support Staff - Non-Union * Regular/Temporary: Regular * End Date if Temporary: * Hours Per Week: 25 * Salary Range: $52,000- $65,000 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 The Hunt Molecular Biophysics Laboratory at Columbia University lab uses structural, thermodynamic, enzymological, and computational methods to understand the molecular mechanisms of complex biochemical processes. Hunt Lab is seeking a part-time scientific Research Coordinator position for a project focused on engineering the amino acid and nucleotide sequences of a human protein for use in genetic therapies. The major job responsibilities are coordinating communication and data interchange between four participating laboratory groups at different institutions, managing a publicly accessible project database, and assisting with related grant-reporting and manuscript-writing activities. This is a part-time role, subject to grant funding. Responsibilities Project Communication & Coordination * Serve as the primary liaison between project participants. * Coordinate biweekly Zoom meetings and follow up on action items. * Maintain consistent communication flow to ensure alignment across all sites. * Oversee and coordinate inter-site sample shipments. * Track sample inventory and ensure proper handling and documentation during transit. * Assist with the preparation and submission of progress reports to the funding agency. Data and Website Management * Coordinate the timely posting of data on the project website. * Ensure proper versioning and data labeling for easy accessibility. * Assist project staff in preparing data for upload to publicly accessible databases. * Make basic content and format updates to the project website. * Organize project resources and data presentations as guided by the team. * Ensure that the website is updated with the latest findings, protocols, and relevant documentation. Final Data Deposition * Oversee the deposition of final results into publicly available databases. * Assist staff with formatting and submission requirements. * Ensure compliance with funder and institutional data-sharing policies. Minimum Qualifications * A bachelor's degree is required in a scientific discipline. * A minimum of three years of experience is needed in a research environment. Preferred Qualifications * Master's or PhD degree strongly desirable. * Rudimentary computer programming skills. * Comfort using a standard computer database system. * Two years of continuous laboratory research experience in a related scientific field. Other Requirements * Basic familiarity with research-level molecular and cellular biology and protein structure studies. * Excellent written, verbal, and interpersonal communication skills. * Ability to maintain high confidentiality and professionalism with a client focus. * Strong multi-tasking, prioritization, and organization skills. * Attention to detail, research, critical thinking, analytical, and problem-solving skills. * Self-starter, a fast learner who can work independently under limited supervision. * Work well in an interactive team environment. Equal Opportunity Employer / Disability / Veteran Columbia University is committed to the hiring of qualified local residents.
    $52k-65k yearly 60d ago
  • Clinical Research Associate - Endocrinology (NYORC)

    Columbia University In The City of New York 4.2company rating

    Clinical research coordinator job at Columbia University in the City of New York

    * Job Type: Support Staff - Non-Union * Regular/Temporary: Regular * Hours Per Week: 20 * Salary Range: $22.85 - $24.04 per hour 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 The New York Obesity Research Center, within the Division of Endocrinology, is seeking a Clinical Research Associate to support the technical aspects of a clinical trial focused on obesity and type 2 diabetes. The study involves participants of diverse backgrounds and age groups. The incumbent will be responsible for biospecimen collection, processing, and shipment to the central laboratory, and will assist with study visits at one of the clinical sites participating in a large, ongoing multicenter clinical trial. Responsibilities * Adhere to all Columbia University clinical research regulations, including COVID-19 safety protocols * Maintain comprehensive knowledge of protocol procedures related to biospecimen processing * Complete training and certification in biospecimen processing per study protocol * Prepare for study visits, including photocopying questionnaires and organizing supplies * Support participant retention efforts (e.g., mailing letters, birthday cards, appreciation gifts, and occasional phone calls) * Assist with calibration and standardization of study equipment (e.g., automatic blood pressure cuffs, stadiometers, scales) * Manage study supplies, including proper storage and maintenance of inventory logs * Perform blood and urine biospecimen collection, processing, and shipment according to strict protocol * Escort participants to offsite imaging centers (e.g., brain MRI and PET scan facilities) * Assist with various aspects of study visits, including providing snacks and meals for participants * Perform related duties as assigned Minimum Qualifications * Bachelor's degree or equivalent in education, training and/or experience * Minimum of five (5) years of phlebotomy experience in a research setting * Strong communication skills and ability to interact with a diverse participant population * Bilingual in Spanish and English * Proficiency in Microsoft Word and Excel * Highly organized and self-motivated * Ability to prioritize and manage multiple tasks while meeting deadlines Preferred Qualifications * Experience in a clinical research environment, with knowledge of HIPAA and Rascal systems Other Requirements * Participation in medical surveillance program * Contact with human subjects * Potential bloodborne pathogen exposure * Successful completion of applicable compliance and systems training requirements Equal Opportunity Employer / Disability / Veteran Columbia University is committed to the hiring of qualified local residents.
    $22.9-24 hourly 60d+ ago
  • Clinical Research Coordinator I - CBCH

    Columbia University In The City of New York 4.2company rating

    Clinical research coordinator job at Columbia University in the City of New York

    * Job Type: Officer of Administration * Regular/Temporary: Regular * Hours Per Week: 35 * Salary Range: $66,300 - $80,000 Annual 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 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 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. At CBCH our goal is to work together as a collective (faculty, admin, and staff) to advance shared values and goals. 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. Responsibilities * Assist with participant recruitment, eligibility screening, and scheduling. * Conduct home-based CR sessions via telehealth, including safety checks, RPM integration, exercise supervision, and maintain appropriate documentation of patient care in Epic/MyChart. * Lead participant onboarding sessions, providing training on devices, exercise equipment, vital sign measurements, apps, RPE scale, and safety protocols. * Recognize contraindications and abnormal participant responses to exercise. * Respond appropriately to all situations, including exercise cessation and referral to medical professionals. * Collect and manage study-related data including session adherence, vital signs, and patient-reported measures. * Collaborate with the study team to identify and report significant observations. * Ensure fidelity to study protocol while integrating with standard-of-care CR workflows. * Perform other duties as assigned. Minimum Qualifications * Master's degree in Clinical Exercise Physiology or related field plus 600 hours of clinical experience or equivalent in education, training and experience. * Strong communication and participant education skills. * Proficiency in exercise testing, ECG interpretation, and risk stratification. * Current CPR/BLS (Professional Rescuer) certification (or obtained prior to start date). Preferred Qualifications * ACSM Clinical Exercise Physiologist (CEP) or AACVPR Certified Cardiac Rehabilitation Professional (CCRP) credential. * Advanced experience with Epic/MyChart and telehealth delivery platforms. * Prior experience in cardiac rehabilitation or secondary prevention. * Research experience, including participant recruitment and data collection. Other Requirements * Strong interpersonal skills, as well as oral and written communication skills, including a record of work in research settings (e.g., presentations/publications). * Experienced in participant-oriented, clinical research. * Must be highly organized, with excellent attention to detail and follow-up skills. * High technical competence related to the use of research devices. * Must be able to work independently, as well as perform as part of a team. * 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. * Strong commitment to equity, diversity, and inclusion. * Participation in medical surveillance program: * Contact with patients and/or human research subjects * Must successfully complete applicable compliance and systems training requirements. Equal Opportunity Employer / Disability / Veteran Columbia University is committed to the hiring of qualified local residents.
    $66.3k-80k yearly 9d ago
  • Clinical Research Coordinator I

    Columbia University In The City of New York 4.2company rating

    Clinical research coordinator job at Columbia University in the City of New York

    * Job Type: Officer of Administration * Bargaining Unit: * Regular/Temporary: Regular * End Date if Temporary: * Hours Per Week: 35 * Standard Work Schedule: * Building: * Salary Range: $64,350- $75,000 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. The Clinical Research Coordinator I manages clinical trials conducted through the Department of Radiology. This position reports directly to the Asst. Director of Clinical Research Operations and the Vice Chair for Clinical Research. Subject to business needs, we may support hybrid work arrangements. Options will be discussed during the interview process. 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 Responsibilities include, but are not limited to: GENERAL STUDY MANAGEMENT * Reviewing research protocols. * Assisting Principal Investigators in study start up and submitting studies to appropriate offices. * Maintaining regulatory documentation and administrative files for each protocol * Under the supervision of the Asst. Director, and Senior CRC, 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. PATIENT MANAGEMENT * Coordinates study enrollment, protocol treatment, and follow-up care for patients participating in clinical trials in conjunction with other study staff as needed. * Working with treating physicians and Principal Investigators to confirm that each patient meets eligibility criteria specified for protocols and enrollment into clinical trials. * 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. * Collecting follow-up data on patients' post-treatment as required by the protocol and entering information into systems for tracking patient enrollment and follow-up visits. Ensuring information is entered into systems for accounts/payments for sponsored protocols. * Completes timely research billing review * Maintains and updates sponsor-related, university and department databases/logs DATA MANAGEMENT * Handling data management requirements for each patient enrolled. * Abstracts, assembles, and organizes clinical research data. OTHER * Coordinator performs other related duties and participates in special projects as assigned. * Other duties as assigned. Minimum Qualifications * Bachelor's degree or equivalent in education and experience required. Other Requirements * Excellent interpersonal and organizational skills * One year of related experience or equivalent in education * Minimum of one year as a Clinical Research Coordinator I or equivalent * Meets or exceeds expectations on annual review (if applicable) * Computer Skills: proficiency with MS Word programs and familiarity with PC platforms Equal Opportunity Employer / Disability / Veteran Columbia University is committed to the hiring of qualified local residents.
    $64.4k-75k yearly 7d ago
  • Clinical Research Coordinator - Hematology & Oncology

    Columbia University In The City of New York 4.2company rating

    Clinical research coordinator job at Columbia University in the City of New York

    * Job Type: Officer of Administration * Regular/Temporary: Regular * Hours Per Week: 35 * Salary Range: $66,300 - $75,000 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. About the Program The Columbia Amyloidosis Multidisciplinary Program (CAMP) is a collaborative clinical and research initiative that brings together experts in hematology, nephrology, cardiology, and neurology to advance the understanding, diagnosis, and treatment of amyloidosis. CAMP integrates patient care with translational and clinical research to improve outcomes and develop innovative therapeutic approaches for individuals affected by this complex disease. Position Summary The Columbia Amyloidosis Multidisciplinary Program (CAMP) is seeking a Clinical Research Coordinator (CRC) to support its expanding clinical and translational research portfolio. The CRC will coordinate day-to-day research operations, including patient recruitment, data collection, and regulatory compliance, while working closely with investigators and clinical teams across multiple disciplines. This position offers the opportunity to contribute to innovative research aimed at improving the diagnosis and treatment of amyloidosis. The CRC will report to the Director of the Multiple Myeloma and Amyloidosis Program and work closely with investigators, clinical staff, and external collaborators. * Work Schedule: Monday-Friday, full-time. * Work Location: Onsite at Columbia University Irving Medical Center. Responsibilities * Coordinate and implement research protocols in collaboration with investigators and clinical staff. * Recruit, screen, and consent study participants in accordance with IRB-approved protocols. * Collect, process, and manage clinical data and biospecimens; administer study questionnaires. * Maintain accurate and timely documentation in electronic data capture systems and case report forms. * Ensure compliance with institutional, federal, and sponsor regulations (e.g., IRB, GCP, HIPAA). * Monitor data quality and resolve discrepancies in collaboration with data coordinating centers. * Assist with IRB submissions, amendments, and continuing reviews. * Communicate effectively with internal and external stakeholders to support study progress. * Perform additional related duties as assigned. Minimum Qualifications * Bachelor's degree or equivalent combination of education and experience. * Strong organizational, communication, and interpersonal skills. * Ability to work independently and collaboratively in a multidisciplinary environment. * High attention to detail and commitment to data integrity and regulatory compliance. Preferred Qualifications * Prior experience in clinical research, patient coordination, or data management. * Familiarity with IRB processes, Good Clinical Practice (GCP), and electronic data capture systems (e.g., REDCap, Medidata). Other Requirements * Medical clearance and participation in the medical surveillance program * Contact with patients and/or human research subjects * Successful completion of applicable compliance and systems training requirements Equal Opportunity Employer / Disability / Veteran Columbia University is committed to the hiring of qualified local residents.
    $66.3k-75k yearly 34d ago
  • Clinical Research Coordinator I

    Columbia University In The City of New York 4.2company rating

    Clinical research coordinator job at Columbia University in the City of New York

    * Job Type: Officer of Administration * Bargaining Unit: * Regular/Temporary: Regular * End Date if Temporary: * Hours Per Week: 35 * Standard Work Schedule: * Building: * Salary Range: $66,300 - $70,000 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. 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-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. To be successful in this role, the Coordinator should bring strong critical thinking, organizational, and an ability to work collaboratively and independently in a deadline-driven environment. Responsibilities Clinical Trials Coordination * 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 elements under some supervision. * Effectively communicate, build, and maintain relationships with potential study subjects, participants, clinicians, and other health care providers, and research office staff to support the successful administration of clinical trials. * Complete data entry activities with little supervision. Data entry may include Protected Health Information (PHI), clinical and billing or other administrative data. * Maintain accurate and complete clinical research files which include administering questionnaires, completing case report forms (CRFs), completing any study start-up or close-out documentation. * Prepare data reports and perform periodic auditing of data, certification, and reporting materials to ensure compliance with university, sponsor and federal policies. * Coordinate fiscal transactions related to the study including compensation to study subjects for their participation and helping them troubleshoot any issues. * Adhere to workplace and patient safety protocols, monitor the area to ensure compliance with ethical and safety standards for research and maintain and request additional supplies as needed. * Uses tools and reporting mechanisms to track progress, identify trends, and ensure timely communication of issues and status. * Represent Columbia University Irving Medical Center research as one of its frontline health research personnel and commit to using culturally appropriate communication methods. * Performs all other duties as assigned. Collaboration & Stakeholder Management * Coordinate research team meetings, investigator check-ins, Sponsor visits, external audits and other stakeholder engagement activities. * Demonstrates professionalism and accountability in interactions with clinical trials team and patients through clear, respectful, and timely communication and responsive follow-up. * Supports training activities to ensure others understand clinical trial procedures. Continuous Improvement * Participates in and/or supports assigned team projects and initiatives and escalates issues or potential barriers. * Keeps current on all organizational policies, goals, and initiatives. * Successfully completes all required university, systems, and department trainings. * Performs all other duties as assigned. Minimum Qualifications * Bachelor's Degree or equivalent in education, training, and experience. * Phlebotomy Certified (or other forms of certification in lieu of phlebotomy such as certified medical assistant, nursing degree, medical degree) - current or obtained within 3 months. * Must possess a customer service orientation, with the ability to interact and collaborate positively, constructively, and effectively with multiple stakeholders. * Capacity to work semi-independently and successfully within teams in a deadline driven, multi-tasking environment. * Ability to handle multiple projects and apply judgment to prioritize projects and tasks. * Strong oral and written communication skills. * Strong commitment to fostering diversity and equity. * Knowledge of Microsoft Office, including strong Excel skills. * Ability and willingness to learn new systems and programs. Preferred Qualifications * Bi-lingual (Spanish and English). * At least 2 years of experience in a relevant clinical research field. * Familiarity with Columbia health and research systems. * Education in a scientific, health-related, or business administration program or experience with observational research or in laboratory setting. * Experience with electronic medical records and/or research data entry, including REDCap and Qualtrics, iLab, or OpenSpeciman. * Knowledge of clinical research systems and processes, Good Clinical Practice (GCP) guidelines, HIPAA, IRB and other regulatory and compliance activities. 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.
    $66.3k-70k yearly 3d ago
  • Clinical Research Coordinator - Cardiology

    Columbia University In The City of New York 4.2company rating

    Clinical research coordinator job at Columbia University in the City of New York

    * Job Type: Officer of Administration * Regular/Temporary: Regular * Hours Per Week: 35 * Salary Range: $66,300.00 - $69,500.00 Annual 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: This entry-level position provides coordination and administrative support for clinical research projects, specifically in Cardiology, under supervision. Responsibilities include data entry in EDC, Redcap, and CTMS, resolving simple queries, extracting data from medical records for study forms, and maintaining research records such as screening/enrollment logs and electronic regulatory files. Additionally, the role may involve participant recruitment, obtaining consent, device accountability, follow-ups, and monitoring visits under supervision. Responsibilities Clinical Coordination * Screen participants for study eligibility and enroll them accurately in various databases. * Utilize information from EMR, databases, CTMS, and EDC. * Understand and execute study protocol requirements and procedures. * Interpret study protocols to ensure compliance. * Maintain proper documentation as per ICH-GCP guidelines. * Complete P-card reimbursement for patients. * Track subject visit billing and invoiceable items. * Assist in study initiation meetings, audits, and monitoring visits. * Perform simple study procedures accurately. * May obtain informed consent from participants. Data Coordination * Enter data in CRFs, databases, or EDCs. * Resolve simple data queries. * Extract and utilize information from EMR and study databases. * Complete basic data collection during study visits. * Document data according to ALCOA-C principles. * Administer surveys and questionnaires. * Perform concomitant medication abstraction. * Build patient research study charts. * Collect external medical records, CLIAs, CAPs, and radiology CDs as assigned. Regulatory Coordination * Maintain documentation following ICH-GCP guidelines. * Work with regulatory support to collect essential documents and maintain regulatory binders (CVs, MD licenses, lab certifications, IRB rosters, lab norms, etc.). * Assist the Regulatory Manager in IRB submissions and management. * Identify and report Adverse Events (AEs), Serious Adverse Events (SAEs), and other safety concerns appropriately. Administrative Support * Provide administrative support, including scanning, filing, and organizing research documents. * Manage research kit organization. * Communicate with study participants via mail or email. * Schedule research visits and follow-up appointments. * Monitor study calendars for procedure completion. * Manage study supply inventory. * Track participant recruitment and retention. * Participate in regular study meetings. * Process payments and reimbursements for participants. * Provide logistic and regulatory guidance on Investigator-Initiated Studies to ensure compliance with university and federal guidelines. * Act as a liaison between investigators, research teams, sponsors, universities, and internal/external departments to resolve issues. Training * Complete required training in CITI, GCP, and HIPAA. * Gain knowledge of EMR, CTMS, EDC, and other relevant databases. * Learn and apply available technology and systems to job responsibilities. * Acquire disease-specific knowledge relevant to assigned programs. * Attend and actively participate in all assigned training. Competencies * Functional Knowledge - Understanding of the general research process, medical terminology, and clinical research coordination in a large healthcare setting. Familiarity with university policies and procedures is preferred. * Problem-Solving - Utilize analytical skills to address simple issues following guidelines and protocols. * Decision-Making & Autonomy - Work under direct supervision to ensure tasks comply with regulations and study requirements. * Communication Skills - Effectively share information and confirm data accuracy. Minimum Qualifications * Bachelor's degree or equivalent in education, training, and experience. Preferred Qualifications * At least two years of related experience * Knowledge of university policies and procedures * Basic knowledge and understanding of clinical research processes, regulations, and the role of a Clinical Research Coordinator (CRC) Other Requirements * Participation in the medical surveillance program * Contact with patients and/or human research subjects * Potential bloodborne pathogen exposure * Successful completion of applicable compliance and systems training requirements Equal Opportunity Employer / Disability / Veteran Columbia University is committed to the hiring of qualified local residents.
    $66.3k-69.5k yearly 3d ago
  • Clinical Research Coordinator - Cardiology

    Columbia University In The City of New York 4.2company rating

    Clinical research coordinator job at Columbia University in the City of New York

    * Job Type: Officer of Administration * Regular/Temporary: Regular * Hours Per Week: 35 * Salary Range: $66,300.00 - $69,500.00 Annual 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 The Clinical Research Coordinator provides research coordination support for multiple clinical research projects. The primary focus of this role is to assist with the coordination of studies rather than independently managing clinical trials. The position involves coordinating various clinical research projects, such as registries, retrospective data reviews, long-term follow-up studies, and other non-interventional studies. Responsibilities Clinical Research Responsibilities: * Screen participants for study eligibility and accurately enroll them in various databases. * Perform simple study procedures with accuracy. * Understand the structure of study protocols and interpret study requirements to ensure compliance. * Follow proper documentation techniques as outlined in the ICH-GCP guidelines. * Process subject reimbursement using pcards. * Retrieve and utilize information from electronic medical records (EMR) and databases/CTMS/EDC. * Maintain essential regulatory documents as required. * Assist the research coordinator in the conduct of Site Initiation Visits (SIV) and attend monitor visits and audits. Data Coordination Responsibilities: * Collect basic demographic information during study visits. * Enter data into forms (CRFs) on paper, databases, or electronic data capture systems (EDCs). * Assist in collecting external medical records and radiology CDs as assigned. * Administer minimal risk consents independently or complex consents under supervision. * Conduct surveys and questionnaires. * Verify the accuracy of own work and resolve simple queries. * Perform concomitant medications abstraction. * Build patient research study charts. * Assist in quality control efforts, such as reviewing consents for signatures. Regulatory Coordination Responsibilities: * Collaborate with regulatory support to collect essential documents and maintain the regulatory binder (e.g., CVs, MD licenses, lab certifications, IRB rosters, lab norms). * Assist with adverse events (AEs) and serious adverse events (SAEs). * Follow proper documentation techniques as outlined in the ICH-GCP guidelines. Administrative Responsibilities: * Demonstrate an understanding of the clinical research objectives associated with the program. * Communicate with study participants by sending study correspondence via mail or email. * Schedule subjects for research visits and follow-up appointments. * Monitor study calendar for completion of study procedures. * Manage study supply inventory. * Utilize documents and systems to track recruitment and retention of participants. * Work with regulatory support to maintain the regulatory binder. Training: * Gain appropriate training and knowledge of electronic medical records (EMR), clinical trial management systems (CTMS), electronic data capture (EDC), databases, and other relevant systems. * Willingly learn and utilize available technology and systems to fulfill job requirements. * Understand the disease process associated with the program. * Attend and actively participate in all assigned training classes. * Perform other responsibilities as assigned. Responsibilities may vary based on the specific needs of the unit or team. Some units/teams may require a proportionate focus on clinical, data, regulatory, or other specific needs. The Clinical Research Coordinator position will primarily support task-oriented needs. Minimum Qualifications * Bachelor's degree in Health Science or equivalent in education, training and experience. Preferred Qualifications * At least two years of related experience. * Knowledge of university policies and procedures. * Previous experience working in a large and complex healthcare setting. * Other Requirements * Familiarity with medical terminology. * Ability to communicate effectively with staff and faculty members at all levels. * Participation in the medical surveillance program * Contact with patients and/or human research subjects * Successful completion of applicable compliance and systems training requirements Equal Opportunity Employer / Disability / Veteran Columbia University is committed to the hiring of qualified local residents.
    $66.3k-69.5k yearly 3d ago
  • Clinical Research Coordinator - General Medicine

    Columbia University In The City of New York 4.2company rating

    Clinical research coordinator job at Columbia University in the City of New York

    * Job Type: Officer of Administration * Regular/Temporary: Regular * Hours Per Week: 35 * Salary Range: $64,350 - $69,350 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 Working in the Division of General Medicine under the direction of the Principal Investigator, the Clinical Research Coordinator will provide coordination and data collection in NIH-sponsored research studies as part of a research team, in collaboration with section leadership and divisional administration. Responsibilities * Conduct study procedures including interviews and neuropsychological testing, and data entry and upload * Schedule and accompany participants for study procedures * Manage petty cash accounts * Responsible for Institutional Review Board (IRB) protocol submissions * Manage FDA's IND applications and approved protocols * Serve as a backup for PET/MRI scheduling and completion, as well as neuropsychological test administration and other study procedures * Perform additional related duties as needed Minimum Qualifications * Bachelor's Degree or equivalent in education and experience * Strong interpersonal and organizational skills * Ability to exercise initiative and judgment * Team player with ability to thrive in busy research environment * Ability to think and write clearly and to edit materials accurately * Ability to work under pressure and meet deadlines, handle multiple projects simultaneously, and prioritize tasks while maintaining responsibility for timely execution * Working knowledge of Microsoft Office: Word, PowerPoint, Excel and Access Preferred Qualifications * Fluency in Spanish highly desirable * Experience in neuropsychological testing and logistics of brain imaging procedures Other Requirements * Participation in the medical surveillance program * Contact with patients and/or human research subjects * Successful completion of applicable compliance and systems training requirements Equal Opportunity Employer / Disability / Veteran Columbia University is committed to the hiring of qualified local residents.
    $64.4k-69.4k yearly 60d+ ago
  • Clinical Research Coordinator

    Columbia University In The City of New York 4.2company rating

    Clinical research coordinator job at Columbia University in the City of New York

    * Job Type: Officer of Administration * Bargaining Unit: * Regular/Temporary: Regular * End Date if Temporary: * Hours Per Week: 35 * Standard Work Schedule: * Building: * Salary Range: $64,350 - $69,000 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 The Clinical Research Coordinator plays an integral role in the coordination and conduct of clinical research in the division of Pulmonology. Reporting directly to the Manager of Clinical Research, the research coordinator will focus on supporting the expansion of research in the areas of Asthma and Cystic Fibrosis (CF). The candidate will work closely with the study team to support the day-to-day operations of various studies and ensure the effective completion of tasks. Additional responsibilities will vary depending on the growth of the division's research portfolio as well as those of the division overall. At CUIMC, we are leaders in teaching, research, and patient care and are proud of the service and support we provide to our community. Columbia University offers a range of benefits to help you, and your dependents stay healthy, build long-term financial security, meet educational and professional goals, and more. Explore your options for Health and Welfare, Employee Assistance, Tuition Programs, and Retirement Benefits. "Subject to business needs, we may support flexible and hybrid work arrangements. Options will be discussed during the interview process" Responsibilities The division runs several research projects in parallel. The candidate must be able to train and certify for different procedures and multitask to ensure project-specific activities are completed in a timely manner. The candidate will: * Work with the Principal Investigators, treating physicians, and research nurse to confirm that each patient meets eligibility criteria specified by protocols for enrollment into clinical trials. * Manage study recruitment activities in person and over the phone * Conduct protocol-specific consenting process * Collect, process, store, and ship participants' specimens as per protocol * Prepare for and conduct study visits, including family counseling activities * Enter and maintain research data, ensuring data quality, integrity, and compliance with all regulatory, institutional, and departmental requirements. * Responsible for accountability of clinic and office supplies * Presents and implements adapted onboarding plans with activities, goals, and time plans * Participate in community outreach activities as a liaison * Complete required regulatory tasks, including IRB submissions, protocol/consent form modifications, maintenance of regulatory binders, and preparation for site visits. * Uses Quality Improvement Standards and practices to influence care teams to adopt best practices. * Perform related duties & responsibilities as assigned/requested by PI, study clinicians and/or study managers. * Performs related duties & responsibilities as assigned/requested. Minimum Qualifications * Bachelor's degree or equivalent and experience required. Preferred Qualifications * Two years of related experience. Other Requirements * Candidate must Successfully undergo a background check prior to receiving a final offer of employment. All background checks for administrative positions will be initiated centrally by the Columbia University Human Resources Background Check (BGC) Team. In compliance with New York City's Fair Chance Act (Background checks are completed in two stages): The Pre-Offer: Verifies Education and Employment history Once employment and education credentials have been verified in a Pre-Offer Background Check, the University may extend an offer of employment. If the candidate accepts, the University then conducts a Post-Offer Criminal Background Check. The post-offer: includes criminal and sexual offender background checks. * HIPAA Privacy and Security Essentials Training. Equal Opportunity Employer / Disability / Veteran Columbia University is committed to the hiring of qualified local residents.
    $64.4k-69k yearly 38d ago
  • Clinical Research Coordinator - CBCH

    Columbia University In The City of New York 4.2company rating

    Clinical research coordinator job at Columbia University in the City of New York

    * Job Type: Officer of Administration * Regular/Temporary: Regular * Hours Per Week: 35 * Salary Range: $66,300 - $67,000 Annual 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 The Center for Behavioral Cardiovascular Health (CBCH) is an innovative, collaborative, interdisciplinary research entity supporting patient-oriented research across diverse populations. 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. The Clinical Research Coordinator (CRC) will collaborate with Project Coordinators, Principal Investigators (PIs), and multidisciplinary teams to implement and manage day-to-day activities for multiple clinical research projects. The role involves participant recruitment and follow-up, protocol execution, data and device management, regulatory coordination, and administrative support. CRCs will also take leadership on at least one sub-study or project component. Work Schedule and Environment * Flexible shifts scheduled between 7:00 a.m. - 8:30 p.m., with occasional weekends. * Work across office, hospital/clinical areas, and community settings. * Team-oriented culture with frequent bilingual (English/Spanish) interactions among patients, families, physicians, and staff. At CBCH, faculty, administrators, and staff work as a collective to advance shared values and goals. We prioritize professionalism, cultural humility, and excellent rapport with participants and colleagues across clinical environments. Responsibilities * Recruit, enroll, and consent study participants (including sensitive questionnaires). Conduct follow-up interviews and sub-study visits in clinical, community, and home settings. Obtain physiologic measures. * Implement protocols, maintain case report forms (CRFs), develop study materials, and manage participant records. * Track, collect, validate, enter, and clean research data. Coordinate with data management staff to implement and monitor electronic data capture systems (REDCap, Qualtrics, FileMaker, Excel). * Utilize and maintain electronic monitoring/tracking devices and other research equipment; oversee inventory and supplies. * Collaborate on strategic plans to enhance enrollment and device utilization; identify trends, troubleshoot issues, and monitor progress against metrics. * Create CONSORT diagrams, prepare progress reports, develop presentations, and present findings at multidisciplinary meetings. * Support IRB submissions, amendments, continuing reviews, and compliance with GCP and HIPAA. * Serve as primary liaison for PIs; collaborate with physicians, outpatient clinicians, advocates, and community partners. * Coordinate participant compensation, support grant and budget preparation, assist with manuscripts, and provide general administrative support. * Perform other responsibilities as assigned. Minimum Qualifications * Bachelor's degree or equivalent in education, training and experience. * Fluency in Spanish (spoken and written). * Demonstrated experience in clinical or participant-oriented research. * Excellent interpersonal, verbal, and written communication skills; ability to engage diverse teams and populations. * Highly organized, detail-oriented, proactive, with strong follow-up and time management skills. * Proficiency with Microsoft Office (Excel required); technical competence with research devices. * Knowledge of Good Clinical Practice (GCP), HIPAA, and research regulations. * Ability to balance independent work with collaboration in a dynamic, team-based environment. * Schedule flexibility to meet project demands and deadlines. Preferred Qualifications * Research experience in healthcare settings. * Familiarity with REDCap, Qualtrics, FileMaker, Excel, and/or SPSS. * Experience with older adult populations (65+). * Prior leadership roles in academic, clinical, or community settings. * Service-oriented experience engaging the public. Other Requirements * Must successfully complete applicable systems and training requirements. * Participation in Medical Surveillance Program: * Contact with patients and/or human research subjects Equal Opportunity Employer / Disability / Veteran Columbia University is committed to the hiring of qualified local residents.
    $66.3k-67k yearly 11d ago
  • Clinical Research Coordinator - Nephrology

    Columbia University In The City of New York 4.2company rating

    Clinical research coordinator job at Columbia University in the City of New York

    * Job Type: Officer of Administration * Regular/Temporary: Regular * Hours Per Week: 35 * Salary Range: $64,350 - $67,000 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 The Division of Nephrology is seeking a Clinical Research Coordinator proficient in Mandarin to support research activities. The Coordinator will be responsible for patient recruitment for genetic and non-genetic studies, assessing eligibility, obtaining informed consent, and administering standardized questionnaires. Additional responsibilities include collecting biospecimens (including kidney biopsy tissue) and clinical data from medical records, scheduling and conducting follow-up visits, entering data into research databases, and ensuring proper storage of human samples. The Coordinator will maintain detailed study files, complete paper and electronic case report forms, and ensure data quality, integrity, and compliance with all regulatory, institutional, and departmental requirements. Additional duties include maintaining databases, generating recruitment reports, assisting with data analysis, and contributing to manuscript and grant preparation. The successful candidate must work effectively in a collaborative team environment, demonstrate strong communication skills, and actively engage in group projects. This position is fully in-person; remote or hybrid work is not available. Responsibilities * Recruit patients and obtain informed consent, ensuring study-specific recruitment and retention goals are met. * Organize and conduct baseline and follow-up study visits. * Collect, process, and store biological samples. * Extract data from medical records and enter into research databases. * Maintain study files and documentation; ensure data quality and compliance with regulatory and institutional requirements. * Prepare periodic reports and assist with data analysis, manuscripts, and grant submissions. * Perform additional related duties as assigned. Minimum Qualifications * Bachelor's degree or equivalent in education, training, and experience. * At least 1 year of related experience * Proficiency in Mandarin. * Strong organizational and communication skills. * Ability to work independently and collaboratively in a team setting. Preferred Qualifications * Clinical research experience in a healthcare setting. * Phlebotomy certification. Other Requirements * Medical clearance and participation in the medical surveillance programs required for contact with human subjects * Contact with patients and/or human research subjects * Potential bloodborne pathogen exposure * Successful completion of applicable compliance and systems training requirements Equal Opportunity Employer / Disability / Veteran Columbia University is committed to the hiring of qualified local residents.
    $64.4k-67k yearly 60d+ ago
  • Clinical Research Coordinator

    Columbia University In The City of New York 4.2company rating

    Clinical research coordinator job at Columbia University in the City of New York

    * Job Type: Officer of Administration * Bargaining Unit: * Regular/Temporary: Regular * End Date if Temporary: * Hours Per Week: 35 * Standard Work Schedule: * Building: * Salary Range: $64,350 - $67,000 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 The Clinical Research Coordinator manages clinical trials conducted through the Clinical Protocol & Data Management Office. This position reports directly to the Clinical Research Manager of the specific disease site this incumbent is assigned to. 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. Subject to business needs, we may support flexible and hybrid work arrangements. Options will be discussed during the interview process. Responsibilities Responsibilities include, but are not limited to: GENERAL STUDY MANAGEMENT * Reviewing research protocols * Assisting Principal Investigators in drafting budgets and submitting studies * Interacting with the regulatory office to maintain regulatory documentation and administrative files for each protocol * Under the supervision of the clinical research management office supervisor, 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 PATIENT MANAGEMENT * 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 * 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 * 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 * Collecting follow-up data on patient 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 * Completes timely research billing review * Maintains and updates sponsor-related, university and department databases/logs DATA MANAGEMENT * Handling data management requirements for each patient enrolled * Abstracts, assembles, and organizes clinical research data OTHER * Coordinator performs other related duties and participates in special projects as assigned Minimum Qualifications * Bachelor's Degree or equivalent in education, training, and experience. Preferred Qualifications * Experience in clinical research setting with knowledge of HIPAA and GCP. Other Requirements * Excellent interpersonal and organizational skills. * Computer Skills: proficiency with MS Word programs and familiarity with Mac and PC platforms. Equal Opportunity Employer / Disability / Veteran Columbia University is committed to the hiring of qualified local residents.
    $64.4k-67k yearly 60d+ ago
  • Clinical Research Coordinator - General Medicine

    Columbia University In The City of New York 4.2company rating

    Clinical research coordinator job at Columbia University in the City of New York

    * Job Type: Officer of Administration * Regular/Temporary: Regular * Hours Per Week: 35 * Salary Range: $66,300 - $66,300 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 The Division of General Medicine seeks a full-time Clinical Research Coordinator (CRC) to assist with clinical research studies related to obesity and cardiometabolic health. Reporting to Principal Investigators, this role will coordinate study activities, ensure compliance with protocols, and contribute to high-quality data collection and analysis. The CRC will work closely with divisional leadership and external collaborators to advance research objectives. Responsibilities * Lead recruitment and screening of prospective study participants. * Manage scheduling and logistics for study visits. * Prepare and maintain study manuals and procedural documentation. * Assist with and lead study visits, including administering questionnaires, overseeing behavioral tests, providing wearable devices, and processing biospecimens. * Coordinate with external site teams for participant recruitment, visit scheduling, and secure data sharing. * Score wearable device data and apply algorithms to behavioral and biomarker datasets. * Maintain internal databases and generate quarterly reports with query resolutions. * Prepare IRB-related documents for renewals, modifications, annual submissions, audits, and correspondence. * Monitor laboratory supply inventories, manage procurement, and confirm invoices for study-related expenses. * Perform additional related duties as needed. Minimum Qualifications * Bachelor's degree in pre-med, biology, biochemistry, nutritional sciences, food science, kinesiology/exercise physiology, or a related field, or equivalent in education and experience * Ability to work onsite full-time * Strong initiative, judgment, and attention to detail * Excellent verbal and written communication skills * Strong interpersonal and organizational abilities * Proficiency in Microsoft Office, especially Excel Preferred Qualifications * Experience in clinical research or health related field * Experience with sensory testing and/or food service * Serve-Safe certification * Prior experience in laboratory or clinic-based settings * Clinical or public health research experience * Coursework in statistics * Strong writing skills Other Requirements * Medical clearance and participation in the medical surveillance program * Contact with patients and/or human research participants * Potential bloodborne pathogen exposure * Successful completion of applicable compliance and systems training requirements Equal Opportunity Employer / Disability / Veteran Columbia University is committed to the hiring of qualified local residents.
    $66.3k-66.3k yearly 30d ago
  • Clinical Research Coordinator - Cardiology

    Columbia University In The City of New York 4.2company rating

    Clinical research coordinator job at Columbia University in the City of New York

    * Job Type: Officer of Administration * Regular/Temporary: Regular * Hours Per Week: 35 * Salary Range: $66,300 - $66,350 Annual 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 Under the direction and supervision of the Principle Investigator and Director, the Clinical Research Coordinator will play a key role in regulatory start-up, maintenance and closeout of protocols. Additionally, the Clinical Research Coordinator will be responsible for maintaining clinical research study databases. Responsibilities * Coordinates all aspects of protocol submission for research projects. * Prepares and submits all necessary documents to the Institutional Review Board (IRB). * Ensures maintenance of up-to-date regulatory records and compliance with industry deadlines. * Coordinates site visits and audits of clinical trials. * Provides assistance for specified investigator-initiated trials. * Serves as the resource for detailed information on assigned protocols and other investigational research activities. * Attends conferences regarding clinical trials and disseminates information to clinical staff. * Clearly and effectively communicates with study subjects, clinicians, and other health care providers, ancillary staff, sponsors, and research office staff. * Complete and maintain the required training for participation in clinical research, including but not limited to, Human Subjects Protection training and Clinical Research Coordinator Course. * Assures Investigator Site Files are ready for inspections, audits and monitoring visits. * Maintains electronic and hard copy files. * Performs other duties as assigned. Minimum Qualifications * Bachelor's degree or equivalent in training, education and/or experience, plus two years of related experience; or advance degree can substitute for experience. Preferred Qualifications * Knowledge of medical terminology. Other Requirements * The ideal candidate will show a demonstrated ability to multi-task, operate efficiently, learn and adapt quickly. * High level of attention to detail and knowledge of basic statistics. * Demonstrated ability to take initiative and able to work independently with minimal supervision. * Ability to work with a wide range of constituencies, and exercise tact and discretion when interacting with faculty, administrators and students. * Communication skills include excellent written communication skills, compassion, discretion, and follow-through. * Proficiency in MS Word, Excel, PowerPoint, Adobe. * Participation in Medical Surveillance Program: * Contact with patients and/or human research subjects * Potential bloodborne pathogen exposure * Must successfully complete applicable systems and compliance training requirements. Equal Opportunity Employer / Disability / Veteran Columbia University is committed to the hiring of qualified local residents.
    $66.3k-66.4k yearly 46d ago
  • Clinical Research Coordinator - Rheumatology

    Columbia University In The City of New York 4.2company rating

    Clinical research coordinator job at Columbia University in the City of New York

    * Job Type: Officer of Administration * Regular/Temporary: Regular * Hours Per Week: 35 * Salary Range: $66,300 $66,300 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 The Clinical Research Coordinator will support multiple research studies (government, private, and pharmaceutical) through the coordination and implementation of clinical trials and protocols involving human subjects. Responsibilities * Study subject management: facilitate screening, enrollment, and treatment of research subjects in compliance with established regulations and guidelines and internal standard operating procedures. * Assists with eligibility assessment and obtaining written informed consent as appropriate. * Functions as a liaison with sponsoring agencies and external sites. * Facilitate sample collection, processing, and storage activities. * Assists with regulatory submissions, including protocol review and monitoring. * Assists with short-term projects and provides cross coverage to various research team members as needed. * Ensures regulatory documents and administrative files for each protocol are up-to-date and adhere to sponsor requirements. * Maintain Study Manager data entry for all assigned studies. * Perform related duties and responsibilities as assigned or requested. Minimum Qualifications * Bachelor's degree or an equivalent combination of education, training, and experience. * Excellent organizational, writing, and verbal communication skills. Preferred Qualifications * At least three years of relevant experience. Other Requirements * Medical clearance and participation in the medical surveillance program * Contact with patients and/or human research subjects * Potential bloodborne pathogen exposure * Successful completion of applicable compliance and systems training requirements Equal Opportunity Employer / Disability / Veteran Columbia University is committed to the hiring of qualified local residents.
    $66.3k yearly 40d ago
  • Clinical Research Coordinator

    Columbia University In The City of New York 4.2company rating

    Clinical research coordinator job at Columbia University in the City of New York

    * Job Type: Officer of Administration * Bargaining Unit: * Regular/Temporary: Regular * End Date if Temporary: * Hours Per Week: 35 * Standard Work Schedule: Mon - Fri (9am - 5pm) * Building: Columbia University Medical Center * Salary Range: $64,350,00 - $65,000.00 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 The Transplant Clinical Research Center (TCRC) in the Department of Surgery is seeking an individual for the position of Clinical Research Coordinator (CRC) who will report directly to the Associate Director of the Transplant Clinical Research Center. The main role of the CRC will be to operate & maintain the day-to-day operational duties of their assigned clinical trials and clinical research study database. Responsibilities * Clearly and effectively communicate with potential study subjects, clinicians, and other health care providers, ancillary staff, sponsors, and research office staff. * Work with regulatory coordinator in submitting new protocols, amendment, renewals and other regulatory bodies * Work with Program Coordinator in preparation of study budget, submitting pharmacy cost estimates, ensuring compliance with research billing and processing stipends for subject's participation in studies. * Coordinate day-to-day aspect of study relayed procedures, including, but not limited to scheduling visits and procedures, data entry, preparation for research visits, research visit documentation, maintenance of regulatory binders and study files, creation and/or maintenance of source documentation, and preparation for monitoring visits, site initiation/closeout visits and audits as needed. * Rotate in an "on call" system for studies where reach procedures are required on weekends or after hours. * Prepare for, participate in, contribute to meetings with the TCRC, PIs, and sponsors. * Processing of specimens for trials as required per study specific protocols. Minimum Qualifications * Bachelor's degree or equivalent in education and experience. * Two years of related experience. Other Requirements * Working knowledge of MS Office, specifically Word and Excel. * Candidate will ensure integrity and compliance with all regulatory, institutional, and departmental requirements. * The ability to take initiative and work independently. * The ability to effectively work in a complex matrix. * Outstanding technical writing skills and understanding of medical terminology/research. * Advanced understanding of data management processes. * Ability to understand and follow scientific research protocol and procedure. * Excellent communication skills (both verbal and written). * Exceptional organizational, interpersonal, and presentation skills. * Ability to understand and follow complex, detailed technical instructions. * Ability to foster a cooperative & collaborative work environment. * Complete and maintain the required training for participation in clinical research, including but not limited to, Human Subjects Protection training and Clinical Research Coordinator Course. * The ability to be flexible with scheduling is mandatory; willingness to work evenings and weekend hours in unusual or emergent situations. Equal Opportunity Employer / Disability / Veteran Columbia University is committed to the hiring of qualified local residents.
    $64.4k-65k yearly 54d ago
  • Clinical Research Coordinator - Cardiology

    Columbia University In The City of New York 4.2company rating

    Clinical research coordinator job at Columbia University in the City of New York

    * Job Type: Officer of Administration * Regular/Temporary: Regular * Hours Per Week: 35 * Salary Range: $64,350.00 to $65,250.00 Annual 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: This entry-level position provides coordination and administrative support for clinical research projects, specifically in Cardiology, under supervision. Responsibilities include data entry in EDC, Redcap, and CTMS, resolving simple queries, extracting data from medical records for study forms, and maintaining research records such as screening/enrollment logs and electronic regulatory files. Additionally, the role may involve participant recruitment, obtaining consent, device accountability, follow-ups, and monitoring visits under supervision. Responsibilities Clinical Coordination * Screen participants for study eligibility and enroll them accurately in various databases. * Utilize information from EMR, databases, CTMS, and EDC. * Understand and execute study protocol requirements and procedures. * Interpret study protocols to ensure compliance. * Maintain proper documentation as per ICH-GCP guidelines. * Complete P-card reimbursement for patients. * Track subject visit billing and invoiceable items. * Assist in study initiation meetings, audits, and monitoring visits. * Perform simple study procedures accurately. * May obtain informed consent from participants. Data Coordination * Enter data in CRFs, databases, or EDCs. * Resolve simple data queries. * Extract and utilize information from EMR and study databases. * Complete basic data collection during study visits. * Document data according to ALCOA-C principles. * Administer surveys and questionnaires. * Perform concomitant medication abstraction. * Build patient research study charts. * Collect external medical records, CLIAs, CAPs, and radiology CDs as assigned. Regulatory Coordination * Maintain documentation following ICH-GCP guidelines. * Work with regulatory support to collect essential documents and maintain regulatory binders (CVs, MD licenses, lab certifications, IRB rosters, lab norms, etc.). * Assist the Regulatory Manager in IRB submissions and management. * Identify and report Adverse Events (AEs), Serious Adverse Events (SAEs), and other safety concerns appropriately. Administrative Support * Provide administrative support, including scanning, filing, and organizing research documents. * Manage research kit organization. * Communicate with study participants via mail or email. * Schedule research visits and follow-up appointments. * Monitor study calendars for procedure completion. * Manage study supply inventory. * Track participant recruitment and retention. * Participate in regular study meetings. * Process payments and reimbursements for participants. * Provide logistic and regulatory guidance on Investigator-Initiated Studies to ensure compliance with university and federal guidelines. * Act as a liaison between investigators, research teams, sponsors, universities, and internal/external departments to resolve issues. Training * Complete required training in CITI, GCP, and HIPAA. * Gain knowledge of EMR, CTMS, EDC, and other relevant databases. * Learn and apply available technology and systems to job responsibilities. * Acquire disease-specific knowledge relevant to assigned programs. * Attend and actively participate in all assigned training. Competencies * Functional Knowledge - Understanding of the general research process, medical terminology, and clinical research coordination in a large healthcare setting. Familiarity with university policies and procedures is preferred. * Problem-Solving - Utilize analytical skills to address simple issues following guidelines and protocols. * Decision-Making & Autonomy - Work under direct supervision to ensure tasks comply with regulations and study requirements. * Communication Skills - Effectively share information and confirm data accuracy. Perform other responsibilities as assigned. Minimum Qualifications * Bachelor's degree or equivalent in education, training, and experience. Preferred Qualifications * At least two years of related experience * Knowledge of university policies and procedures * Basic knowledge and understanding of clinical research processes, regulations, and the role of a Clinical Research Coordinator (CRC) Other Requirements * Participation in the medical surveillance program * Contact with patients and/or human research subjects * Potential bloodborne pathogen exposure * Successful completion of applicable compliance and systems training requirements Equal Opportunity Employer / Disability / Veteran Columbia University is committed to the hiring of qualified local residents.
    $64.4k-65.3k yearly 60d+ ago
  • Clinical Research Coordinator

    Columbia University In The City of New York 4.2company rating

    Clinical research coordinator job at Columbia University in the City of New York

    * Job Type: Officer of Administration * Bargaining Unit: * Regular/Temporary: Regular * End Date if Temporary: * Hours Per Week: 35 * Standard Work Schedule: * Building: * Salary Range: $64,350 - $65,000 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 The Section of Oncology at Columbia University Medical Center is recruiting for the position of a Clinical Research Coordinator (CRC). The employee will work within the Division of Hematology, Oncology and Stem Cell Transplantation. The section of Oncology has a cadre of Phase 1 and 2 trials, investigator-initiated studies, and industry sponsored studies. The CRC will be assigned to studies based on need and review of clinical trial roster. The CRC will work with investigators, study staff, Scientific Review Committee (SRC) and institutional review boards (IRB), clinical trial sponsors and federal regulatory agencies to assure compliance with study protocols, data documentation, reporting requirements, ensure that regulatory requirements for clinical trials are met. The CRC will work under the supervision of the Section Head, Divisional Administrator and CTO Program Manager. At CUIMC, we are leaders in teaching, research, and patient care and are proud of the service and support we provide to our community. We apply the same rigor in our commitment to fostering an inclusive, thriving community and caring for our employees and their loved ones. Columbia University offers a range of benefits to help you and your dependents stay healthy, build long-term financial security, meet educational and professional goals, and more. Explore your options for Health and Welfare, Employee Assistance, Tuition Programs, and Retirement Benefits. "Subject to business needs, we may support flexible and hybrid work arrangements. Options will be discussed during the interview process" Responsibilities * Schedule all protocol required evaluations (physical exams, radiology, labs, etc.) * Coordinate patient appointments with physicians, nurses and all test areas. * Attend Investigator meetings, which establish required procedures. * Coordinate, obtain, process (e.g. spin/separate/freeze samples), and ship (e.g. utilization of specific packaging and ensuring proper handling and shipping of samples) protocol required samples. * Obtain vital signs and EKGs as indicated. * Maintain accurate patient research files and records of sample procurement. * Develop protocol specific flow charts, intake sheets and other tools as needed to ensure protocol compliance and proper data acquisition. * Maintain study supplies and utilizes study specific supplies as required. * Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training. * Assists Principal Investigator to assure that all key personnel or persons 'engaged' in the research project have met training requirements in accordance with federal regulations and university and sponsoring agency policies and procedures. * Cooperates with university compliance and monitoring efforts related to sponsored program administration and reports instances of noncompliance to the appropriate compliance office. * Coordinates and facilitates monitoring auditing visits and notifies appropriate institutional officials of external audits by FDA and sponsors. * Collaborates with PI and institution to respond to any audit findings and implement-approved recommendations. * Cooperates with university and sponsoring agency compliance and monitoring efforts related to human research participant protection and reports instances of noncompliance to the appropriate compliance office. * Establish and maintain regular communication with study team, study sponsor, and applicable regulatory agencies to ensure all required information is communicated. * Serve as facilitator for study team and sponsor with regard to study status information, safety issues, upcoming protocol amendments, consent changes, and applicable protocol training. * Prepares and submits all protocol applications, amendments, continuing reviews, and informed consent documents for SRC and IRB review and approval. * Prepares and submits regulatory documentation that may include IND/IDE applications, FDA annual reports, Serious Adverse Event reports, to the appropriate regulatory agencies including the Food and Drug Administration (FDA) etc. * Coordinates assigned study monitoring and auditing visits with study coordinator, investigator, industry sponsors, and internal/external auditors. * Performs related duties & responsibilities as assigned/requested. Minimum Qualifications * Bachelor's degree or equivalent and experience required. Preferred Qualifications * Two years of related experience. * Protocol oversight; monitoring and reporting of study events; data collection; adherence to study protocols; in-service education of physicians, nurses, and support staff to protocol requirements; coordinate research activities. Equal Opportunity Employer / Disability / Veteran Columbia University is committed to the hiring of qualified local residents.
    $64.4k-65k yearly 48d ago

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