Florida Cras Jobs

Job Overview

Senior Clinical Research Associate - Contract

• Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
• Perform monitoring and site management activities for Phase I - IV clinical research projects to assess the progress of clinical projects at assigned investigative / physician sites to ensure clinical projects are conducted, recorded, & reported in accordance with protocol.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject / patient as required / appropriate.
• Other duties / responsibilities as assigned.
• Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Perform site qualification, site initiation, interim monitoring, site management and close-out visits ensuring regulatory, ICH-GCP and / or GPP and protocol compliance.

Job Expectations (Cont.)

• Travel: Expectation right now is probably visiting sites 8 days per month on average. Potential to travel up to 75% of the time depending on the study.
• Therapeutic Area: CNS (Alzheimer\'s Disease, ADHD, and other Neurological Trials)
• Strong communication and writing skills
• Experience with Rave and Microsoft One Note, Excel & Word preferred.
• Requirements: 18 Months of Independent Monitoring Onsite.

SRG ED&I and EEO Statement

• EEO Statement: Impellam Group is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
• ED&I: Impellam Group and its brands are equal opportunity employers committed to diversity and inclusion.