Clinical Research Associate II

Role Responsibilities

• Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines
• 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
• Monitors (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations
• Plans day-to-day activities for monitoring a clinical study and sets priorities per site
• Prepares for and conducts on-site or remote qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites as required by clinical monitoring plan
• Takes the initiative to move the project/program forward by reducing backlog and keeping it at a minimum
• Monitors with knowledge of quality/scope/timeline and budget parameters
• Works with the Clinical Lead or equivalent to enhance and proactively manage site visits and trial issues during the monitoring phase
• Monitors the quality of clinical deliverables and addresses quality issues with the appropriate team member. Escalates appropriately and in a timely manner to the appropriate team member
• Manages query resolution process with sites and Premier Research Data Management
• Maintains Trial Master File (TMF)/electronic Trial Master File (eTMF) as defined by the organization's processes per filing guidelines. Maintains an understanding of the required essential documents according to ICH/GCP Appendix C. Reviews site documents and verifies they are accurate, complete, current, and include required updates
• Assists project team with assessing project feasibility and recruitment, as applicable
• Maintains project tracking system of subjects and site information, as applicable
• Participates in Investigators' Meeting as designated by the Project Manager
• Maintains communication with study sites as directed per CMP, and in agreement with the study site and complete documentation of contacts
• Attends meetings as required
• Ensures site visit metrics and utilization are maintained as required and escalates available time as necessary to line manager
• Completes timely entry of hours worked and project codes per time entry guidelines
• Maintains high level of attention to detail to ensure subject safety for our projects and delivery of quality data for our clients
• Acquire basic knowledge of disease or condition under study. Participates in available training offered to increase therapeutic knowledge
• Review of IP accountability and applicable logs (subject and site level) as directed per the Clinical Monitoring Plan
• Maintains proper, timely communication with study teams and management, as needed
• Completes all required internal training (general and study-specific) on-time
• Identifies confidential information and complies with global and local laws and guidelines
• In specific countries or situations, the CRA may be requested to also assume additional country specific responsibilities, being appointed as Subject Matter Expert in one or more areas including but not limited to the following: Start-up, Regulatory, Site Contracts, Office Manager, etc.
• In specific projects, the CRA may be requested to also assume additional project specific responsibilities, e.g. Clinical Management for smaller or less complex studies, under the appropriate supervision of the line manager or functional lead
• Acts as a resource for other CRAs and shares knowledge base and best practices
• Performs other activities as designated

Requirements

• Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required
• 2+ years' experience in clinical trials and proven previous success as a CRA; previous clinical research experience required, completion of CRA training program
• Read, write and speak fluent English; fluent in host country language
• Experience in coaching/mentoring other CRAs
• Global experience preferred
• Knowledge of ICH / GCP regulations
• Working knowledge of FDA Guidance Documents / EU Directives / local regulations / ISO14155 regulations, drug / device development, and clinical monitoring procedures
• Knowledge of web-based communication tools for conferences and any other IT systems required for the job
• Knowledge of clinical/health systems as well as knowledge of cultural/professional practices appropriate to the country/region where the site monitoring activities will be carried out
• Full-time availability to internal and external project team members
• Excellent team player, collaborative and able to enable an effective team
• Ability to multitask and work effectively in a fast-paced environment with changing priorities
• Strong verbal and written communication skills
• Excellent organizational and time-management skills, able to meet deadlines
• Self-starter with a lot of common sense and able to act on own initiative
• Accountable, dependable and strong commitment
• Applies clear and consistent performance standards and handles problems decisively and objectively
• Customer service focused in approach to work, both internally and externally
• Maintains a positive, results orientated work environment
• Travel: 70-85%
• Lifting up to 25lbs
• Valid driver's license, passport as required