Clinical Research Associate

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 CRA's to join our Monitoring Resources team in the USA. This position will be remote, but will require travel.

ResponsibilitiesMonitor 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 projectsConduct 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/IMsPerform source document verification, validate Case Report Forms (CRFs) and perform query resolution in a timely manner to ensure clean data availability for studies analysesInput and maintain study information in tracking systems:

Provide regular/accurate sites status updates and common site trends to Monitoring Resources and Project Management DepartmentsOversee 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, SOPsRespond to requests from clinical study sites in a timely fashionEstablish and maintain good rapport with clinical study sitesQualificationsAt least 2 years of oncology experience as CRA in the field; or very strong experience as Research Nurse or Study Coordinator in oncologyBachelor's Degree in allied health fields such as Medical, Nursing, Pharmacy, or Health Science – or its international equivalentLocal regulatory requirements knowledge would be a major asset Early phase experience with Breast, Lung, Gastric, and/or Ovarian Tumors would be a major assetGood knowledge of medical terminology and clinical monitoring process Strong ICH-GCPs knowledge Ability to prioritize multiple tasks and achieve project timelinesEffective 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 averageWhat TRIO Can Offer YouCompetitive Salary 3 weeks of vacation plus paid Christmas Closure2 weeks paid personal/sick time100% health benefits for you and your family paid by TRIOFlexible working hoursMonthly internet allowance401K Program 5% Salary ContributionHome office allowance Luggage allowance Pay Range:

$110,000 - $150,000. Salary to be influenced (or determined) by the education, experience, location, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data.