IBM Watson Health Biomedical Research Coordinator in St Louis, Missouri

Job Description

Preferred location for this role is Boston, MA, New York, NY or Nashville, TN.

The Biomedical Research Coordinator is responsible for the design, authoring, and conduct of research protocols and the coordination of approval processes to maintain the integrity and quality of the biomedical research and ensure the research is conducted in accordance with Good Clinical Practice Guidelines; federal, state, and international regulations and guidelines; and institutional partner policies and procedures. The research coordinator manages research study conduct from study design through study closeout, and duties include implementing recruitment procedures, consenting, enrollment, randomization, data collection, and data verification. The Research Coordinator works with Biomedical Research Program Managers to implement processes to ensure study-related procedures are performed as required, and objectives and timelines set by are met. The Biomedical Research Coordinator creates and maintains accurate and timely documentation and communication with investigators, study participants, regulatory bodies, institutional partners, and other research related entities.

This Biomedical Research Coordinator has the following essential functions: design and conduct of research protocols, preparation and maintenance of research and regulatory documentation

  • Prepares and processes new research protocols, amendments, continuing review applications, and adverse event reports according to institutional and regulatory policies and procedures with the assistance of investigators

  • Communicates a basic knowledge and understanding of the management and implementation of clinical and translational research studies, including multi-center and industry-sponsored studies

  • Uses coordination skills and works collaboratively with study participants, other research staff, and institutional partners to complete research protocols, including performing study procedures such as assessing participant eligibility, recruitment, obtaining consent, collecting research data, scheduling research activities, and performing follow up procedures

  • Prepares and maintains documents required for regulatory bodies

  • Participates in periodic site visits from regulatory authorities and others to review research, source documentation and research procedures

  • Assures research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice

  • Monitors, detects, and reports adverse events meeting requirements of regulatory bodies

  • Organizes study completion, study closeout, and archiving of study files, ensuring completeness and accuracy of all study data

  • When applicable, develops and manages study budgets with assistance of Research Program Managers, taking appropriate action to maintain clinical trial billing compliance

  • Organizes and collaboratively participates in study team meetings, maintaining open and positive communications with investigators, participants, co-workers, and institutional partners

  • Instructs others, including institutional collaborators in performing procedures and maintaining documentation for research and

  • Actively identifies and participates in research training and educational activities for research team members

  • Participates in and maintains relevant certifications, licensure, and credentialing as required by regulatory bodies or institutional partners

Essential knowledge and skills:

  • Knowledge of biomedical and clinical research processes

  • Knowledge of health care delivery including work flows and settings, health outcomes and measurement, health IT, health economics, research publication processes

  • Knowledge of health data sources and data management

  • Skill at managing and coordinating multiple high priority projects and tasks

  • Knowledge and understanding of policies, procedures, and regulations governing biomedical and human subjects research

  • Knowledge of the federal regulations and guidelines governing biomedical research and the protection of human subjects (e.g., FDA, OHRP, GCP/ICH guidelines, and HIPAA regulations)

  • Knowledge of safety reporting requirements of the research protocols, FDA and other regulatory bodies

  • Excellent verbal and written communication skills

Necessary experience:

  • Five or more years of experience in coordinating biomedical and/or clinical research studies

  • Five or more years of experience working for a biomedical informatics, health informatics, clinical research enterprise or life science company

  • Broad understanding of most of the functions involved in the development of a biomedical informatics application such as clinical decision support, health informatics or life sciences product

Required Technical and Professional Expertise

  • Bachelor’s Degree

  • At least 5 years’ experience working in as a research coordinator in a biomedical or clinical research sciences setting

Preferred Tech and Prof Experience

  • At least 2 years’ experience in clinical research settings

  • At least 5 years’ experience in a research coordinator role

  • Registered nurse preferred but not required

EO Statement

IBM is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. IBM is also committed to compliance with all fair employment practices regarding citizenship and immigration status.