Job Title: Senior Clinical Research Associate

　　Location: San Antonio, TX

　　Type: Full-time

　　Compensation: Salaried: $115,000 - $145,000

　　Must haves:

　　Educational requirement: BA/BS

　　Years of experience: 2+ years of CRA (monitoring experience) - Ideally looking for folks with 5 years of field CRA experience

　　Industry experience: 5+ years of clinical research industry experience

　　Diabetes experience is a nice to have

　　Remote Monitoring Experience

　　Risk Based Monitoring

　　Current Phase I CRA Healthy Patient monitoring experience

　　Job Description:

　　KEY AREAS OF RESPONSIBILITY

　　Site Management

　　Responsible for providing site management and support to external trial staff (Principal Investigators and Study Coordinators) from trial initiation to closeout

　　Ensure collection of high quality data, timely adverse event reporting, subject protection and compliance to the protocol

　　Adherence to ICH-GCP, regulatory requirements, local ethics requirements, Company SOPs, and Clinical Development Guidelines

　　Manage recruitment and retention strategies at the site level, analyzing enrollment and randomization projections against actual recruitment numbers to ensure targets are met

　　Collaborates regularly with Local Trial Manager (LTM) and Line of Business Manager, communicating site progress and escalating critical issues that could impact trial milestones

　　Trains and supports external trial staff regarding requirements for CRF and IVRS data entry, AE/SAE/MESI reporting, ethics reporting, protocol deviation identification, drug accountability and temperature monitoring, query resolution, essential document collection and ITF filing

　　Identifies objectives for scheduled monitoring visits; ensures planned visit objectives are achieved to meet protocol and SOP timelines.

　　Prepares and completes monitoring visit reports and follow up letters within the timeline established by the applicable SOPs and guidelines

　　Completes system training (IMPACT, IV/WRS, EDC, CATS, CONCUR etc.) in order to adhere to protocol and SOP timelines to meet required deliverables.

　　Proactive use of EDC and other data source systems for preparation and conduct of site visits as well as source data verification in collaboration with data management/logistics team

　　Identify potential risks and proactively take action to prevent or mitigate

　　Participates in Sponsor and Regulatory audits; preparing external trial staff and site records, addressing questions from Auditor, supporting external trial staff during audit, preparing audit responses ensuring compliance to local guidelines, Company SOPs and ICH-GCP.

　　Other:

　　Adheres to Company policies, procedures ,vision and fundamentals

　　Acts as back up to the other monitors during absences, as requested

　　Performs other tasks as assigned by management

　　WORKING CONDITIONS

　　Works from a home office environment at least one day a week

　　Works at hospitals, medical clinics three to four times a week

　　May be required to drive, fly or take train to location to perform duties of the job

　　Up to 70% travel required

　　System One offers eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

　　#M3

　　System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

　　System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.