Offer summary

Qualifications:

Minimum of 2 years of oncology experience as a Clinical Research Associate or strong background as a Research Nurse or Study Coordinator in oncology., Bachelor's Degree in Medical, Nursing, Pharmacy, Health Science, or equivalent., Knowledge of local regulatory requirements and medical terminology., Strong understanding of ICH-GCP guidelines and clinical monitoring processes..

Key responsibilities:

Monitor clinical study sites to ensure compliance with protocols and regulations.

Conduct various site visits including pre-study, initiation, routine monitoring, and close-out.

Perform source data verification and manage study documentation and drug accountability.

Establish good rapport with clinical sites and respond promptly to their requests.

Job description

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

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 studyspecific SGsIMs,
for multiple projects
Conduct PreStudy Site Visits (or calls), Study Initiation Visits, Routine Monitoring Visits
and Site Closeout at assigned clinical study sites as per TRIO SOPsSGsIMs and study
specific SGsIMs
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 regularaccurate 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 destructionreturn)
Perform Investigator Study File reconciliation: request any new or updated siterelated
essential documents and review them for content, consistency with other documents,
and compliance with local regulatory requirements, ICHGCPs guidelines, SOPs
Respond to requests from clinical study sites in a timely fashion
Establish and maintain good rapport with clinical study sites