- Job Type: Officer of Administration
- Bargaining Unit:
- Regular/Temporary: Regular
- End Date if Temporary:
- Hours Per Week: 28
- Standard Work Schedule:
- Building:
- Salary Range: $51,480 - $52,500
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 research and development department at Columbia University Fertility (CUFC) is pleased to offer an exciting new position as a Clinical Research Coordinator I. In this position, the CRCI will work alongside the clinical staff and laboratory staff on innovative and exciting new developments in reproductive medicine and fertility.
The research team at CUFC is pivotal in facilitating and advancing these cutting-edge research endeavors. Advancements made in the CUFC lab helped the center to earn the title of #1 Fertility Center in the United States.
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.
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 protocol elements under direct supervision.
- 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.
- 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.
- Maintain accurate and complete clinical research files, which may include administering questionnaires and maintenance of case report forms (CRFs)
- 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.
- Possess understanding and awareness of Corrective and Preventative Actions (CAPA).
- Coordinate financial 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 and ensure compliance with ethical and safety standards for research, and maintain research supply inventor, requesting additional items as needed.
- Assists in submission of closeout documents to applicable agencies and sponsoring parties in accordance with policies and procedures.
- Performs all other duties as assigned.
Laboratory Duties
- Process biospecimens and perform molecular genetic techniques according to standard operating protocols.
Collaboration & Stakeholder Management
- Ensure timely notification and/or communication between the Principal Investigator and compliance offices and study sponsors.
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.
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.
- Strong commitment to fostering diversity and equity.
- Working 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.
