Clinical Research Associate

Translational Research in Oncology

1d•$112,000 - $146,000•Remote

About The Position

If you are an experienced Clinical Research Associate who is passionate about oncology research and looking to join a highly skilled and knowledgeable team, TRIO is the place for you! Translational Research in Oncology (TRIO) is a global academic clinical research organization dedicated to advancing translational cancer research in the clinical trial setting. Our passionate team is committed to providing cancer treatments of the future to the world of today. TRIO is looking for a CRA to join our Monitoring Resources team in the USA. This position will be remote, based out of the West Coast, and will require travel.

Requirements

At least 2 years of oncology experience as CRA, Coordinator, and/or research nurse.
Bachelor's Degree in allied health fields such as Medical, Nursing, Pharmacy, or Health Science – or its international equivalent
Local regulatory requirements knowledge would be a major asset
At least one year of experience on an early phase trial
Expereince with Breast, Lung, Gastric, and/or Ovarian Tumors would be a major asset
Good knowledge of medical terminology and clinical monitoring process
Strong ICH-GCPs knowledge
Ability to prioritize multiple tasks and achieve project timelines
Effective time management in order to meet daily metrics or team objectives
Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail
Ability to travel up to 60% on average

Responsibilities

Monitor activities at assigned clinical study sites to assure adherence to ICH GCPs, local regulatory requirements, TRIO Standard Operating Procedures (SOPs), Standard Guidelines (SGs), Instruction Manuals (IMs), study protocols and study-specific SGs/IMs, for multiple projects
Conduct Pre-Study Site Visits (or calls), Study Initiation Visits, Routine Monitoring Visits and Site Close-out at assigned clinical study sites as per TRIO SOPs/SGs/IMs and study- specific SGs/IMs
Perform source document verification, validate Case Report Forms (CRFs) and perform query resolution in a timely manner to ensure clean data availability for studies analyses
Input and maintain study information in tracking systems: Provide regular/accurate sites status updates and common site trends to Monitoring Resources and Project Management Departments
Oversee study drug management at clinical study sites (availability, receipt, handling, storage, dispensation, tracking and accountability, and destruction/return)
Perform Investigator Study File reconciliation: request any new or updated site-related essential documents and review them for content, consistency with other documents, and compliance with local regulatory requirements, ICH-GCPs guidelines, SOPs
Respond to requests from clinical study sites in a timely fashion
Establish and maintain good rapport with clinical study sites