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CRC I is an entry-level position responsible for serving as the primary coordinator for post-market, phase 3, and pivotal studies – and serving as the backup coordinator for all other phase studies. Supports both inpatient and outpatient research across all age groups and indications.
Job Responsibility:
Oversees, coordinates, develops, and manages the day-to-day clinical activities for specified research trials
Facilitate and coordinate daily clinical activities
Act as liaison between PI’s, ancillary departments, research subjects, sponsoring organizations and regulating bodies, vendors, brokers, and suppliers
Maintain regulatory documentation, including the Investigator Site File (ISF)
Prepare, submit, and track Institutional Review Board (IRB) submissions, amendments, and reports
Ensure investigational product (IP) accountability throughout the study
Coordinate study and Research Staff compliance metrics
Coordinate participant recruitment and outreach programs
Coordinate department quality and data integrity programs
Support research billing compliance and invoicing/financial administration
Conduct interviews, schedule participant appointments, administer surveys for research purposes, collect and aggregate data, and act as patient liaison for the PI
Serve as a member of the research team
Maintain required documentation including source documentation, subject logs, various records, reports, and other essential documents
Perform data mining and data entry
Develop contingency plans and respond to unforeseen circumstances
Serve as program liaison between the department and research partners
Order and maintain study supplies
Adhere to TMCH organizational and department-specific safety, confidentiality, values, policies, and standards
Requirements:
Bachelor’s degree in a relevant field or equivalent experience
Good Clinical Practice, Human Research Protection Training, and Basic Life Support certifications required within 30 days of start date
Ability to understand clinical research theory, practices, and tools utilized
Above-average skill in the use of all Microsoft Office applications
Proficient with technology and comfortable learning new protocols, electronic data capture (EDC) systems, and electronic medical records (EMRs)
Knowledge of clinical care and assessment best practices
Knowledge of regulations and policies as they relate to patient research, evaluation, care, and information
Ability to maintain investigational product accountability
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
Ability to read, analyze, and interpret professional journals, technical procedures, or governmental regulations
Highly organized and able to multi-task
Ability to write reports, correspondence, and procedure protocols
Ability to effectively present information and respond to inquiries or complaints
Ability to work with concepts such as fractions, percentages, ratios, and proportions
Requires problem solving, decision-making, critical thinking, analytical, and deduction skills
Ability to work with diverse populations and adjust approaches as needed
Must maintain a positive and professional attitude through stressful situations
Must be able to work in a self-directed environment, with an ability to work with teams