The individual will function as administrator, coordinator, consultant, educator and researcher in research trial management and will be involved in all aspects of clinical trials research, including data collection, analysis, and/or monitoring. The Research Manager will initate the grant application process, complete all IRB requirements, develop strategic plans for protocol implementation, enroll patients, manage protocols, supervise research support personnel, analyze and interpret research data and provide management reports. The ideal candidate will work in a fast-paced environment with minimal supervision, and have the ability to communicate effectively and provide quality care for patients.
The candidate will be responsible for preparing and maintaining all IRB submissions, renewals modifications, and protocol-specific regulatory documents. A successful candidate will lead, train, and manage study personnel while working closely with members of the clinical team to maximize efficient coordination of procedures, tests and visits for patients participating in research and ensure protocol compliance and compliance with all GCP, FDA/HHS, and institutional, state and federal guidelines. This includes working with the research staff, physicians, clinical nurses and Principal Investigators to confirm that each patient meets eligibility criteria specified for protocols and educating pertinent clinical staff about the protocol. He/she will work with outside departments, physicians and labs, including outside hospitals, to ensure accurate and timely retrieval of data. The Inpatient Research Manager will provide back-up for the research team by performing research-related services as needed including but not limited to coordinating, scheduling and performing study visits, making telephone calls, collecting, entering and transmitting data, and collecting, processing, storing and shipping specimens.
The candidate will be responsible for identifying deficiencies and discrepancies in the day to day workflow and develops strategic solutions and corrective action plans as needed.
Manage research personnel
Completion of GCP, HIPAA and applicable regulatory training
Complete certification requirements for assigned protocols
Screen designated schedules or patient lists for eligible subjects
Approach and verify eligibility subjects
Consent and enroll eligible subjects
Complete research study visits as delineated in assigned protocol and manual of operations set forth by sponsor and supervisor.
Complete Telephone follow-up and telephone reminder calls for study participants, during these phone calls the person will need to administer study questionnaire as assigned
Coordinate the collection of all research data points as assigned, whether through research visits, chart abstraction or telephone.
Scheduling of research visits
Collection through veni-puncture of biological specimens
Processing, transporting and shipping of biological specimens as assigned and following of instructions as delineated in the protocol or manual of operations.
Completion of study documents and files; some examples might include case report forms, worksheets and medical record notes.
Maintain confidentiality of documents and files such as HIPAA.
Assist in other research related activities and projects as needed
Regular collaboration with the PI and other research staff
Lead CRC of project or network
Develop and maintain procedures for organizing work and staff
Attend investigator meetings as needed
Carry out required staff training and provide the direct supervision for assigned staff
Maintenance of study documents and files, such as regulatory binders and CVs etc.
Preparation and completion of feasibility surveys
Contribute to the grant application process
Develop plans for protocol implementation, identify necessary resources and request as appropriate. This includes instruments, equipment and staff.
Determine recruitment objectives and develop systems to monitor and track achievement
Carry out required staff training and provide the direct supervision for clinical research staff
Develop all day to day plan and procedures for data collection as well as data confidentiality and data security.
Responsible for mechanisms and details of protocol adherence and for providing administrative back-up to PI
Preparation and submission of annual reports and regulatory information to funding and regulatory agencies
Develop local systems for secure storage of drugs and supplies and be the point of contact for the research pharmacy
Preparation of IRB applications
Preparation and submission of regulatory documentation to the regulatory bodies as relevant
Assist investigators with validation and editing of collected data
Analyze study data and assist in preparing manuscript
Development of project budgets
Work closely with central Research Administration team on post-award monitoring of sponsored research expenditures
Adhering to approved clinical research budgets
Bachelor's degree or equivalent in education and experience, plus four years of related experience.
ACRP or SOCRA certification
Phlebotomy certificate within 6 months of hire.
Experience in a clinical research setting, especially randomized controlled trials: Industry sponsored research experience. Experience with budget maintenance, government grants and contract and/or clinical trials management
Experience interacting with of patients
Experience with personnel management
Capable of working on multiple studies and multi-tasking
Knowledge of medical terminology
Excellent interpersonal, written/oral communication, and organizational skills are required
Proficiency in Microsoft Office
Complete proficiency in written and spoken English
Knowledge of SPSS
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Internal Number: 498808
About Columbia University
Columbia University is one of the world's most important centers of research and at the same time a distinctive and distinguished learning environment for undergraduates and graduate students in many scholarly and professional fields. The University recognizes the importance of its location in New York City and seeks to link its research and teaching to the vast resources of a great metropolis. It seeks to attract a diverse and international faculty and student body, to support research and teaching on global issues, and to create academic relationships with many countries and regions. It expects all areas of the university to advance knowledge and learning at the highest level and to convey the products of its efforts to the world.