About this role
Under the supervision of a Clinical Research Supervisor or Principal Investigator (PI), the incumbent will perform entry-level duties related to the support and coordination of clinical studies, and may receive training and development to prepare and advance for journey-level work at the next level within the series. May be responsible for the coordination of one or more single or multi-site, active or follow-up clinical trials; help prepare protocols for study initiation; help design flow sheets, data forms and source documents; gather and interpret medical, surgical and laboratory data regarding clinical trial subjects; may apply understanding of inclusion/exclusion eligibility criteria for protocols; help recruit, enroll, register, schedule and retain study subjects; record protocol specific treatments and assure collection and shipment of samples; assist research personnel to keep patients on study schedules; complete study forms to submit to sponsors and/or appropriate agencies; collect, enter and clean data into study databases, maintaining data quality; assist with data analysis; assist with preparation of reports and tables; attend team meetings; and perform other duties as assigned.
% of time (Nothing less than 5%) Essential Function (Yes/No) Key Responsibilities (To be completed by Supervisor)
40 YES Patient Management Working in collaboration with others, schedules, leads, and tracks patient visits, tests, procedures and follow up according to protocol; provides calendars and schedules to patients; in collaboration with team members, codes and documents toxicities and adverse events; reports adverse events to appropriate University and outside agencies; obtains, processes and ships specimens.
10 YES Patient Registration Works with Investigators to verify history and medical information to assure inclusion/exclusion criteria are met; schedules screening tests and procedures; registers and randomizes patients on trials and/or studies.
30 YES Data Management Abstracts clinical data from medical records; enters data onto case report forms, study flow sheets, and other forms; submits required data and data forms in accordance with accuracy and timeliness requirements of the protocols; addresses and resolves data queries; identifies, investigates and resolves data quality issues
20 YES Miscellaneous Helps prepare for audits/monitoring visits by sponsors and/or regulatory agencies; Monitors study supply inventory and reorders as needed; maintains research charts and study binders; and performs other related duties as assigned.
100% (To update total %, enter the amount of time in whole numbers (without the % symbol - e.g., 15, 20) then highlight the total sum (e.g., 1%) at the bottom of the column and press F9. The total sum should add up to 100%.)
• HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities or equivalent training/experience • Excellent verbal and written communications and presentation skills; excellent organizational skills; and excellent interpersonal skills to work effectively in a diverse team. • Attention to details; • Proficiency with Microsoft Word, PowerPoint, and Windows. • Excellent analytical and problem-solving skills. • Ability to work effectively in a fast-paced, team-based environment; project management and coordination skills; ability to prioritize tasks and meet multiple deadlines on concurrent projects. • Ability to establish cooperative working relationships with patients, co-workers, & physicians. Preferred Qualifications
• Prior experience working on multi-site clinical high risk studies • Experience working with schizophrenia patient population • Demonstrated proficiency with medical terminology. • Demonstrated proficiency with EEG • Ability to abstract data from medical records and transfer it to data collection forms or directly into databases. • Experience applying the following regulations and guidelines: • Good Clinical Practice Guidelines • Health Information and Accountability Act (HIPAA) • The Protection of Human Research Subjects • CHR regulations for recruitment and consent of research subjects • Effective Cash Handling Procedures • Environmental Health and Safety Training • Fire Safety Training