Clinical Research Associate

Title: Clinical Research Associate Location: Remote - 30% travel Type: Direct-HireSalary: 80-90k base salary with an annual bonus performance based, typically 10-20%, very variable, PTO is 28 days/year, healthcare, disability, life insurance, 401k match Responsibilities:

Develops strong investigative site relationships and ensures continuity of investigative site relationships through all phases of the trial (will be performing on site monitoring and remote monitoring)

Conducts site visits including but not limited to Pre-study visits, initiation visits, interim monitoring visits, close-out visits to ensure compliance with protocols, Sponsor SOPs, ICH/GCP and all applicable regulations

Performs remote and on-site monitoring & oversight activities using various tools to ensure data generated at the site are complete, accurate, and unbiased; subjects' rights, safety, and well-being are protected

Collects, reviews, and monitors required regulatory documents for study start-up, study maintenance, and study close-out

Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, missing data and data queries, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance

Identifies, assesses, and resolves site performance, quality, or compliance problems and escalates per protocol to upper management

Performs investigational product accountability through physical inventory and record review

Participates & provides inputs on site selection activities

Supports audit/inspection activities as needed

Work with in-house Clinical Trial Assistant to collect, review, and monitor required regulatory documentation for study start-up, study maintenance, and study close-out.

Requirements:

Bachelor's degree in Sciences from an accredited institution with strong emphasis in science and/or biology

Minimum of 2-3 years of direct site management experience in a bio/pharma/ Clinical Research Organization

Minimum of 1-3 years of clinical monitoring or direct site management experience in a bio/pharma/ Clinical Research Organization in the oncology space. Site level experience is required – knowledge of imaging, resistance (clinical trial coordination, study start up), and experience managing oncology trials at big academic centers

Applicants may be eligible to work remotely depending on location

Ability to travel domestically approximately 50% of working time

Current driver's license preferred

COVID vaccination required

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.