Position Summary Full-Time Day Shift $15.75 - $22.52

Responsible for submitting protocols to the Institutional Review Boards for research and maintaining accurate protocol files.

Highlights & Benefits Paid Time Off (PTO)Memorial ChildcareMental Health Services Growth OpportunitiesContinuing EducationLocal and National DiscountsPet InsuranceMedical, Dental, VisionFlexible Spending Account401(k)Life Insurance and Voluntary BenefitsEmployee Assistance Program and Colleague WellnessAdoption Assistance Required Skills Coordinates and/or prepares materials for timely submission to the IRB for the research office. Retrieves protocol documents from each research base, either electronic or paper. Reviews new protocol submissions and makes necessary modifications required by the local IRBs. Accurately completes required IRB forms prior to IRB submission; summarizes protocol revisions; summarizes SAE reports. Requests required PI signatures. Submits documents to IRB Administrators. Communicates and coordinates with research bases and pharmaceutical companies to ensure proper materials are submitted and filed. Organizes and maintains protocol files, including central office, physician offices, radiation oncology, pharmacy, and DMH oncology department, and disseminates protocol documents to appropriate staff in a timely manner. Keeps accurate records of protocol activities and IRB submissions. Enters protocol information into research database. Tracks protocols to ensure timely submissions for annual reviews. Gathers information needed to complete annual review. Forwards necessary information/completed forms to appropriate staff for review and finalization of annual reviews. Completes and maintains drug accountability logs forms (DARFs) for the DMH pharmacy and the CCSCI pharmacy. Collaborates with other staff to ensure ALL protocol information is organized and completed. Serves as a back up to other Regulatory Compliance Coordinators in their absence.  Communicates with Director and staff in regards to any protocol activation delays or problems. Prepares records for audits. Records are assessable and organized for research base, pharmaceutical, and FDA audits. Performs other duties as assigned. Required Experience

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required. 

Excellent word processing skills.  Experience with computer databases and medical terminology.  Experience with adobe acrobat and internet.  Must be able to communicate effectively and to organize and prioritize work.

 

General Skill Requirements

In addition to the Essential Functions and Qualifications listed above, to perform the job successfully an individual must also possess the following General Skill Requirements.

Adaptability – Adapts to changes in the work environment; Manages competing demands; Accepts criticism and feedback; Changes approach or method to best fit the situation; ability to work with frustrating situations; work under pressure and on an irregular schedule such as unscheduled overtime, unanticipated changes in work pace; Works with numerous distractions. Attendance and Punctuality – Schedules time off in advance; Begins working on time; Keeps absences within guidelines; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time. Communications – Expresses ideas and thoughts verbally; Expresses ideas and thoughts in written form; Exhibits good listening and comprehension; Keeps others adequately informed; Selects and uses appropriate communication methods. Cooperation – Establishes and maintains effective relations; Exhibits tact and consideration; Displays positive outlook and pleasant manner; Offers assistance and support to co-workers; Works cooperatively in group situations; Works actively to resolve conflicts. Job Knowledge – Competent in required job skills and knowledge; Exhibits ability to learn and apply new skills; Keeps abreast of current developments; Requires minimal supervision; Displays understanding of how job relates to others; Uses resources effectively. Judgment – displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions; ability to work with and maintain confidential information. Problem solving – Identifies problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Resolves problems in early stages; Works well in group problem solving situations. Quality – Demonstrates accuracy and thoroughness; Displays commitment to excellence; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality. Quantity – Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly; Achieves established goals. Concentration – Maintains attention to detail over extended period of time; continually aware of variations in changing situations. Supervision – ability to perform work independently or with minimal supervision; ability to assign and/or review work; train and/or evaluate other employees.

Education and/or Other Requirements

High school graduate or equivalent with general businesses courses.  Prefer two to five years experience as administrative assistant.

Decatur, IL