Clinical Research Associate II

Premier Research Group Limited - United States3.2

The Clinical Research Associate (CRA) is accountable for conducting monitoring activities of assigned clinical trials in compliance with the protocol, ICH-GCP/ISO14155 and all applicable local laws and regulations, company policies and quality standards. He or she performs the management of study site activities to ensure the collection of accurate clinical data within given timelines. The CRA proactively identifies, resolves/mitigates and escalates risks and/or issues, may be responsible for multiple studies and must work independently with team support. Position can be regional or office based.

You’ll be accountable for:
Delivering high-quality, timely monitoring reports for sponsor approval per Clinical Monitoring Plan timelines
Scheduling site visits for monitoring as required by protocol monitoring visit windows
Maintains submission of expenses according to travel and expense requirements within company guidelines
Responsible for the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP/ISO14155, protocol and client requirements

You’ll be responsible for:
Monitoring data — remotely, on site, and via other approved modes — with a focus on data integrity and patient safety, in accordance with specific country regulations
Planning day-to-day activities for study monitoring and setting priorities by site
Preparing for and conducting qualification, study initiation, interim monitoring, and close-out visits at investigator sites
Working with the line manager and CM to ensure that visit metrics are maintained as required
Gauging the quality of clinical deliverables and addressing quality issues with team members
Providing accurate and timely trip reports and records of hours worked.
Managing query resolution with study sites and Premier Research data management operations
Maintaining the project tracking system of subjects and site information
Participating in Investigators’ Meetings as assigned by Project Managers
Maintaining contact with investigator sites via telephone calls between visits
Ensuring adherence to study timelines and budgets
Identifying and escalating potential risks and identifying retraining opportunities for site study teams

You’ll also contribute by:
Being a resource for other CRAs, mentoring CRA's as appropriate and sharing knowledge and best practices.
Participating in training offered to increase therapeutic knowledge and keeping current with regulations and FDA guidance.
In specific countries or situations, assuming country-specific responsibilities and/or being named a subject-matter expert in one or more areas; e.g.: start-up, regulatory, site contracts, office management.
Assuming additional duties on certain projects, such as clinical management for smaller or less complex studies.
Experience and Qualifications

Bachelor’s Degree or equivalent experience required
2+ years of on-site monitoring experience with all types of site visits
Travel requirement up to 75%