Clinical Research Associate II

🔥 0 minutes ago

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

PSI CRO AG

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1996

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

PSI CRO AG is a global contract research organization (CRO) that specializes in conducting clinical trials. The company focuses on delivering pivotal Phase 2 and 3 clinical trials across various therapeutic areas, including Inflammatory Bowel Diseases, Oncology, Hematology, Infectious Diseases, Multiple Sclerosis, and Rare Diseases. PSI utilizes a proprietary technology platform for clinical trial planning and financial tracking to ensure trials are conducted on time and within budget. The company is recognized for its expertise, quality, compatibility, and reliability, having been awarded the CRO Leadership Awards for multiple consecutive years.

📋 Description

• Act as the main line of communication between the project team, sponsor, and the site • Build and maintain relationships with site staff involved in study conduct • Prepare, conduct, and report site selection, initiation, routine monitoring, and close-out visits • Define, communicate, record, and meet subject recruitment targets and follow project timelines at site level • Ensure accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations • Perform source data verification and follow up on data queries at site level • Review and manage study risks at site level • Handle, use, account for, reconcile, and return Investigational Products and clinical study supplies • Review essential study documents and reconcile Investigator Site File / TMF at site level • Ensure data integrity, compliance, and quality at site level • Conduct site audit preparation visits and resolve site audit findings • Participate in study site audits and client onsite visits as required • Coordinate document and study-supply flow between project teams, sites, laboratories, reviewers, and warehouses • Conduct project-specific training for site investigators • Support preparation of Investigator newsletters • Assist Site Management Associates with study-specific and corporate tracking systems • Support preparation of draft regulatory and ethics committee submission packages • Support collection of IP-RED packages at site/country level • Facilitate review and reconciliation of the study TMF on country and site levels

🎯 Requirements

• College/University degree in Life Sciences or an equivalent combination of education, training & experience • Located in the Central or West Coast regions is preferred • Must have 2+ years of independent on-site monitoring experience • Experience in all types of monitoring visits, in phases I-III • Experience in Oncology mandatory • GI preferred and/or radio-pharm experience preferred • Full working proficiency in English • Proficiency in MS Office applications • Ability to plan, multitask and work in a dynamic team environment • Communication, collaboration, and problem-solving skills • Ability to travel up to 75% • Valid driver’s license (if applicable) • PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future