Position Information
Requisition Number
097254
Departmental Job Title
Clinical Trials Coordinator
Type of Position
Staff
Number of Positions Available
1
Division
Biological Sciences
Department
20121-BSD-Neurology
*Standard Summary
Works under the general direction of a Clinical Trials Manager and the Director of Clinical Research. Works closely with Principal Investigators (PI) and sponsoring agents. Interacts with regulatory agents, Institutional Review Board (IRB) personnel, patients, department staff, and hospital staff. Manages all aspects of conducting clinical trials including: screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports. Maintains accurate and complete documentation of signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, and study related communication. Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules. Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications. Prepares and maintains protocol submissions and revisions. Educates patients about study procedures to be performed, visit schedule, what to report between and during visits, and potential side effects. Performs assessments at visits and monitors for adverse events. Organizes and attends site visits from sponsors and other relevant study meetings. May recruit and interview potential study patients. May obtain, possess, and transport specimens to appropriate laboratory according to established aseptic techniques.
About the Unit
Unit Job Summary
Works under the general direction of the Director of Clinical Research. Works closely with Principal Investigators (PI), Co-investigators, other study personnel, and sponsoring agents.
Interacts with regulatory agents, Institutional Review Board (IRB) personnel, patients, department staff, and hospital staff. Manages all aspects of conducting clinical trials including: screening, enrollment, study patient visits, subject follow-up, completion of the case report form, and adverse event reports. Completes study training and/or certifications per study requirments. Maintains accurate and complete documentation of signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, electronic data entry,and study related communication. Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules. Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications. Prepares and maintains protocol submissions and revisions. Educates patients about study procedures to be performed, visit schedule, what to report between and during visits, and potential side effects. Performs assessments at visits and monitors for adverse events. Organizes and attends site visits from sponsors and other relevant study meetings. May recruit and interview potential study patients. May obtain, possess, and transport specimens to appropriate laboratory according to study requirements and established aseptic techniques.
Interacts with regulatory agents, Institutional Review Board (IRB) personnel, patients, department staff, and hospital staff. Manages all aspects of conducting clinical trials including: screening, enrollment, study patient visits, subject follow-up, completion of the case report form, and adverse event reports. Completes study training and/or certifications per study requirments. Maintains accurate and complete documentation of signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, electronic data entry,and study related communication. Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules. Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications. Prepares and maintains protocol submissions and revisions. Educates patients about study procedures to be performed, visit schedule, what to report between and during visits, and potential side effects. Performs assessments at visits and monitors for adverse events. Organizes and attends site visits from sponsors and other relevant study meetings. May recruit and interview potential study patients. May obtain, possess, and transport specimens to appropriate laboratory according to study requirements and established aseptic techniques.
Education
Bachelor's degree or a combination of education and related work experience required.
Experience
Some relevant postsecondary work experience required.
Some clinical research experience preferred.
Some clinical research experience preferred.
Competencies
Knowledge of patient evaluation and triage procedures and the ability to monitor clinical research patients from many disciplines required.
Thorough working knowledge of medical terminology required.
Knowledge of Microsoft Word and Excel required.
Ability to travel to occasional national and international meetings required.
Demonstrated excellent written and verbal skills required.
Strong organizational and problem-solving skills required.
Demonstrated excellent interpersonal skills required.
Demonstrated ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others required.
Adaptability to changing working situations and work assignments required.
Familiarity with Microsoft Outlook, Word, Excel, and PowerPoint preferred.
Thorough working knowledge of medical terminology required.
Knowledge of Microsoft Word and Excel required.
Ability to travel to occasional national and international meetings required.
Demonstrated excellent written and verbal skills required.
Strong organizational and problem-solving skills required.
Demonstrated excellent interpersonal skills required.
Demonstrated ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others required.
Adaptability to changing working situations and work assignments required.
Familiarity with Microsoft Outlook, Word, Excel, and PowerPoint preferred.
Required Job Seeker Documents
Resume
Cover Letter
Cover Letter
Optional Job Seeker Documents
Resume
Work Location
Campus - Hyde Park
Other Work Location
Work Schedule
Full-Time
Hours/Week
40
If other than regular hours (M-F, 8:30-5:00) please detail
regular
Benefits Eligible?
Yes
Union (If applicable):
Non-Union
Pay Grade
NA
Pay Range
Depends on Qualifications
Pay Frequency
Biweekly
Does this position require incumbent to operate a vehicle on the job?
No
Is a Background Check Required?
Yes
Is Drug Testing Required?
Yes
Employee Referral Bonus Amount
None
Posting Date
11-10-2014
Remove from posting on or before
05-10-2015
