Clinical Research Coordinator III

• Job Type: Officer of Administration
• Bargaining Unit:
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 35
• Standard Work Schedule:
• Building:
• Salary Range: $75,000 - $80,000

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.

Working in the Department of Obstetrics and Gynecology the CRC III will support the coordination of clinical research activities according to clinical research studies or trials managed by the Department. The CRC III works with complex trials, serves as a mentor as applicable, and is responsible for day-to-day study monitoring activities. They will also 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. The individual will monitor and support all administrative items of the research portfolio and support the ARPA-H program , NICHD-sponsored Prenatal Sequencing Repository, and support the IRBs of the Global Network.

A research background is highly preferred.

Responsibilities

Clinical Trials Coordination

• Serving as the lead CRC, they are responsible for day-to-date aspects of study protocol tasks including participant recruitment, screening, enrollment and follow-up with study participants, specimen processing, and other key protocol elements.
• Effectively communicate, verbally and written, build and maintain relationships with potential study subjects, participants, clinicians, and other health care providers, and reach office staff to support the successful administration of clinical trials.
• Design recruitment and retention plans for a range of different study populations utilizing different modes of communication. Recruit and enroll for genetics studies as assigned following all regulatory procedures.
• Complete data entry activities, including Protected Health Information (PHI), clinical, billing, and other administrative data with minimal supervision and summarize and assist in analyzing operational data for the research team.
• Coordinate day-to-day aspects of study relayed procedures, samples, documentation, and visit management.
• Maintain accurate and complete clinical research files which may include administering questionnaires, completing case report forms (CRFs), completing any study start-up or close-out documentation. Implement the study start up and site initiation visit (SVI).
• 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 area to ensure compliance with ethical and safety standards for research. Coordinate and manage regulatory procedures for human subject research for assigned protocols (genetics and global network).
• Maintain the research supply inventory, requesting additional items as needed.
• Develops or contributes to the development of standard operating procedures, best practices and supporting tools required for maintaining subject confidentiality and privacy. Ensure that regulatory files are audit ready.
• Represent Columbia University Irving Medical Center research as one of its frontline health research personnel and commit to using culturally appropriate communication methods.
• Responsible for preparation of documents for new projects, renewals, modifications, yearly submissions, correspondence, and audits related to IRB for multiple ongoing NIH-sponsored research studies, other genetics projects, Women's Genetics Center protocols, ARPA-H program and the Global Network. Assist in the preparation of annual reports including regulatory information to funding and regulatory agencies.
• Manage MTAs/DUA's for projects as applicable.
• Organize and maintain manifests for all samples in genetics biobank.
• Performs all other related duties and responsibilities as assigned/requested.

Clinical Genetic Testing Coordinator

• Provide back up coverage for the genetic testing coordinator in the Women's Genetics Center. This includes tracking samples, accessioning samples, shipping samples and communicating updates about sample status with genetic counselors, New York Genome Center, and other relevant stakeholders.

Collaboration & Stakeholder Management

• Demonstrates professionalism and accountability in interactions with clinical trials team and patients through clear, respectful, and timely communication and responsive follow-up.
• Assist with writing reports and manuscripts detailing research findings, program updates and others as applicable. Support ARPA-H Principal Investigator, Associate director and junior genetics faculty in abstracts and publications - set goals, deadlines, support submissions.
• Manage and execute successful grant submissions under the direction of the Associate Director; identify funding sources, plan deadlines, manage administration of applications.

Continuous Improvement

• Participates in and/or supports assigned team projects and initiatives and escalates issues or potential barriers.
• Serves as a mentor and process expert for research staff and identifies potential vulnerabilities in research studies, including data, resource allocation, and compliance.
• Keeps current on all organizational policies, goals, and initiatives.
• Successfully completes all required university, systems, and department trainings.

Minimum Qualifications

• Bachelor's degree and at least 3 years of relevant clinical research experience required, including in an academic/medical setting.
• 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.
• Strong understanding of clinical research compliance regulations and protocols.
• Must possess strong critical thinking and analytical skills, customer-service orientation, with the ability to interact and collaborate positively, constructively and effectively with multiple stakeholders.
• Capacity to work independently and successfully within a deadline driven, multi-tasking environment. Ability to handle multiple projects and apply judgment to prioritize projects and tasks.
• A demonstrated commitment to upholder the integrity and standards established for clinical research coordinators by professional organizations such as ACRP AND SOCRA.
• Strong commitment to fostering diversity and equity.
• Skilled with Microsoft Office, including strong Excel skills.
• Ability and willingness to learn new systems and programs.

Preferred Qualifications

• Bi-lingual (Spanish and English).
• CRC professional certification from ACRP, SOCRA, or equivalent agency.
• Familiarity with Columbia health and research systems.
• Education in a scientific, health related, or business administration program or experience with research or laboratory settings.
• Experience with electronic medical records and/or research data entry, including Epic, REDCap, Qualtrics, iLab, or OpenSpeciman.
• Research or laboratory experience preferred.
• Experience coordinating complex clinical trials from start to finish.

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.