Clinical Research Manager - Digestive & Liver Diseases
- Job Type: Officer of Administration
- Bargaining Unit: n/a
- Regular/Temporary: Regular
- End Date if Temporary: n/a
- Hours Per Week: 35
- Salary Range: Commensurate with experience
Position Summary
Working with the Clinical Research Directors, Principal Investigators, and Research Nurses, the Clinical Research Manager (CRM) will oversee the day-to-day activities of the complex clinical research operations of the Division of Digestive & Liver Diseases. Responsible for general oversight of all projects within the division.
Responsibilities
- Coordinates data collection, quality assurance, analysis and preparation.
- Identifies, screens and assesses study participants.
- Writes proposals, plans prospective studies, and designs protocols and sampling tools.
- Develops divisional Standard Operating Procedures (SOPs) for the conduct of clinical research.
- Recruits, trains and supervises technical staff.
- Oversees and helps supervise clinical research coordinators ensuring appropriate coverage for research study visits.
- Responsible for on-boarding and training newly hired coordinators.
- Takes an active role in the teaching of rules, policies, procedures and systems to the new hires in order to ensure successful navigation of their own research projects.
- Supervises clinical research coordinators to ensure safety of all study participants.
- Assists and mentors new research hires in the Division.
- Helps establish a cohesive research team through monthly meetings and ongoing collaboration/communication for the entire division where all coordinators can come together to share best practices, standard operating procedures and knowledge.
- Writes reports and assists in drafting manuscripts and papers.
- Assists in developing and monitoring project budgets ensuring efficient and cost effective administration and financial management of research projects in compliance with internal and external policies and procedures.
- Reconciles expenditures on a monthly basis, and develops and maintains internal financial control system to monitor non-salary expenditures of all projects and clinical trials.
- Assists the Division Administrator with monitoring compliance including JCAHO, CUMC/NYP, and Environmental Health and Safety requirements.
- Performs additional related duties as needed or assigned.
Minimum Qualifications
- Bachelor's degree or the equivalent in training, education and/or experience, plus four years of related experience
- Clinical research and/or nursing experience
Preferred Qualifications
- Master's degree in Public Health or related field preferred and may substitute in part for experience
- At least two years of experience in database administration
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.