Clinical Research Associate
Praxis
Google Cloud Platform
Senior Clinical Research Associate
Iovance Biotherapeutics, Inc.
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Independently manages the study start up activities for multi-center, US and/or global based studies.
- Performs on-site visits (feasibility, SIV, IMV, Close-Out) with CRO CRAs as needed to assess the sites’ and CRA’s overall performance.
- Provides monitoring oversight by reviewing monitoring schedules, metrics and reports.
- Responsible for the clinical site training and sites adherence to protocol, all applicable GCP/ICH guidelines, regulations statutes and SOPs.
- Leads or participates in vendor management activities (e.g., Central Laboratory, Central Imaging, CRO).
- Performs in-house routine data listings review.
- Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
- Supports CTM and cross-functional representatives as required in relationship management tasks (e.g., contracts, study logistics, patient enrollment, safety, data management, etc.) to accurately coordinate clinical study activities.
- Mentors and coaches’ junior staff new to Clinical Research (e.g. Clinical Trial Assistants).
- Assists with the development of protocol writing, informed consent development, CRFs, monitoring conventions, tracking forms, and other study related documents.
- Assists in managing and/or leading the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
- Performs other duties and assignments as required for the overall success of the projects.
Requirements
- BS/BA, RN, or equivalent with at least 4 years of clinical trial monitoring / clinical trial management and vendor experience in accordance with CFR, GCP and ICH Guidelines.
- 8+ years of clinical operations experience.
- Most have experience in Solid Tumor or Cell Therapy.
- Must have strong knowledge of ICH/GCP guidelines.
- Must have strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring.
- Strong experience managing early to late phases clinical studies and working with CROs and other study vendors.
- Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.
- Excellent organizational, record retention, time management, decision making, customer service, and interpersonal skills.
- Good command of written and spoken English language.
- Excellent computer skills in the following programs: MS Word, PowerPoint, Excel and Project.
- Ability to “roll up your sleeves” and individually contribute results to a research and development effort.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical trial monitoringclinical trial managementvendor managementprotocol writinginformed consent developmentclinical study designstudy planningdata managementregulatory documentationmonitoring conventions
Soft skills
interpersonal skillswritten communicationverbal communicationadministrative skillsorganizational skillstime managementdecision makingcustomer servicementoringcoaching
Certifications
BS/BARNGCP certificationICH certification
