Clinical Research Specialist II, Infectious Disease

%3Cb%3EA Brief Overview%3C/b%3E%3C/br%3E%3Cp%3EWorks with the Principal Investigator to coordinate all aspects of implementation of assigned multiple and/or complex clinical research trials.%3C/p%3E%3Cb%3EWhat You Will Do%3C/b%3E%3C/br%3E%3Cul%3E%3Cli%3EResponsible for submission of related documents to the appropriate regulatory review committees and maintenance of regulatory files. (10%; Competency 1, 2)%3C/li%3E%3Cli%3EPerforms all activities related to clinical research studies including but not limited to: screening participants for eligibility and recruitment, obtains informed consent, educates participants regarding study requirements and completes case report forms (CRF). (20%; Competency 1, 2)%3C/li%3E%3Cli%3EResponsible for in-depth knowledge of protocol requirements and Good Clinical Practice (GCP) guidelines. (10%; Competency 1, 2)%3C/li%3E%3Cli%3EDocuments, records and assimilates accurate participant records and study records to ensure documentation compliance with sponsor guidelines, standard operating procedures (SOP) and internal and external regulatory agencies. (20%; Competency 1, 2)%3C/li%3E%3Cli%3EAssists with SOP, grant and protocol development and active participant in preparation of manuscripts and presentations for scientific meetings. (10%; Competency 2,3)%3C/li%3E%3Cli%3EEstablish and maintain communications with Investigator, Sponsor and internal constituents. (10%; Competency 1, 2)%3C/li%3E%3Cli%3EMentorship of the clinical research process to the junior clinical research staff. (10%; Competency 3)%3C/li%3E%3Cli%3EPerforms other related duties as assigned or required. (10%; Competency 1, 2, 3)%3C/li%3E%3C/ul%3E%3Cb%3EAdditional Responsibilities%3C/b%3E%3C/br%3E%3Cul%3E%3Cli%3EPerforms other duties as assigned.%3C/li%3E%3Cli%3EComplies with all policies and standards.%3C/li%3E%3Cli%3EFor specific duties and responsibilities, refer to documentation provided by the department during orientation.%3C/li%3E%3Cli%3EMust abide by all requirements to safely and securely maintain Protected Health Information (PHI) for our patients. Annual training, the UH Code of Conduct and UH policies and procedures are in place to address appropriate use of PHI in the workplace.%3C/li%3E%3C/ul%3E
%3Cb%3EEducation%3C/b%3E%3C/br%3E%3Cul%3E%3Cli%3EBachelor%27s Degree (Required) %3C/li%3E%3C/ul%3E%3Cb%3EWork Experience%3C/b%3E%3C/br%3E%3Cul%3E%3Cli%3E2+ years clinical research experience (Required) and %3C/li%3E%3Cli%3E Experience in a team setting (Required) %3C/li%3E%3C/ul%3E%3Cb%3EKnowledge, Skills, %26amp; Abilities%3C/b%3E%3C/br%3E%3Cul%3E%3Cli%3E Ability to prioritize the work of multiple projects. (Required proficiency) %3C/li%3E%3Cli%3E Knowledge of GCP and FDA guidelines. (Required proficiency) %3C/li%3E%3Cli%3E Knowledge of Electronic Data Capture Programs. (Required proficiency) %3C/li%3E%3Cli%3E Medical %26amp; Research Terminology. (Required proficiency) %3C/li%3E%3Cli%3E DOT/IATA Training (Preferred proficiency) %3C/li%3E%3Cli%3E Ability to train and mentor junior staff. (Required proficiency) %3C/li%3E%3Cli%3E Detail-oriented person with the ability to collect, compile, and analyze information. (Required proficiency) %3C/li%3E%3Cli%3E Ability to understand and communicate research protocol requirements to others. Able to work independently on multiple tasks and manage time effectively. (Required proficiency) %3C/li%3E%3Cli%3E Demonstrates customer service excellence with internal and external customers (Required proficiency) %3C/li%3E%3Cli%3E Excellent verbal, written, interpersonal and communication skills. (Required proficiency) %3C/li%3E%3Cli%3E Computer skills (Outlook, Excel, PowerPoint, Word). (Required proficiency) %3C/li%3E%3C/ul%3E%3Cb%3ELicenses and Certifications%3C/b%3E%3C/br%3E%3Cul%3E%3Cli%3ECertification in Human Subjects Protection (CITI) (Required within 30 Days) %3C/li%3E%3Cli%3ESociety of Clinical Research Associates (SoCRA) (Preferred) or %3C/li%3E%3Cli%3EACRP Certified Professional (ACRP-CP) (Preferred) %3C/li%3E%3C/ul%3E%3Cb%3EPhysical Demands%3C/b%3E%3C/br%3E%3Cul%3E%3Cli%3EStanding Frequently %3C/li%3E%3Cli%3EWalking Frequently %3C/li%3E%3Cli%3ESitting Rarely %3C/li%3E%3Cli%3ELifting Frequently up to 50 lbs %3C/li%3E%3Cli%3ECarrying Frequently up to 50 lbs %3C/li%3E%3Cli%3EPushing Frequently up to 50 lbs %3C/li%3E%3Cli%3EPulling Frequently up to 50 lbs %3C/li%3E%3Cli%3EClimbing Occasionally up to 50 lbs %3C/li%3E%3Cli%3EBalancing Occasionally %3C/li%3E%3Cli%3EStooping Frequently %3C/li%3E%3Cli%3EKneeling Frequently %3C/li%3E%3Cli%3ECrouching Frequently %3C/li%3E%3Cli%3ECrawling Occasionally %3C/li%3E%3Cli%3EReaching Frequently %3C/li%3E%3Cli%3EHandling Frequently %3C/li%3E%3Cli%3EGrasping Frequently %3C/li%3E%3Cli%3EFeeling Constantly %3C/li%3E%3Cli%3ETalking Constantly %3C/li%3E%3Cli%3EHearing Constantly %3C/li%3E%3Cli%3ERepetitive Motions Constantly %3C/li%3E%3Cli%3EEye/Hand/Foot Coordination Constantly %3C/li%3E%3C/ul%3E%3Cb%3ETravel Requirements%3C/b%3E%3C/br%3E%3Cul%3E%3Cli%3E10% Travel may be required %3C/li%3E%3C/ul%3E

Job Details
Primary Location: United States-Ohio-Cleveland
Work Locations: 11100 Euclid Avenue, Cleveland, 44106
Job: Research
Organization: CMC_Operations
Schedule: Full-time
Employee Status: Regular
Shift: Days
Job Type: Standard
Job Level: Professional
Travel: Yes, 10 % of the Time
Remote Work: No
Job Posting: Sep 28, 2026, 11:31:56 AM