Job Description

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