Clinical Research Associate I (CRA Academy)

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• Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan (CMP) 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, on site or other approved mode of monitoring) with a focus on data integrity and subject safety in accordance with local/regional laws and country specific regulations
• Plans day-to-day activities for monitoring of a clinical study and sets priorities per site
• Prepares for and conducts on site and/or remote qualification, study initiation, interim monitoring, dosing observation, and close out monitoring visits as directed per CMP
• Properly manages data backlog rates and/or devises a suitable plan for reducing high backlog rates as required

• 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/escalates quality issues with the appropriate team member in a timely manner
• 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 Section 8. Regularly 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 and completes required documentation of contacts as directed per CMP
• Attends meetings as required
• Ensures site visit metrics and utilization are maintained as required and escalates available time to line manager
• Completes daily entry of hours worked and project codes per time entry guidelines
• Maintains high level of attention to detail to ensure subject safety and delivery of quality data for our projects/clients

• Acquires basic knowledge of disease or condition under study. Participates in available training offered to increase therapeutic knowledge
• Reviews IP/Device accountability and applicable logs (subject and site level) as directed per the CMP
• 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/regional 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. This will be documented with the appropriate guidance or functional description
• In specific projects, the CRA may be requested to also assume additional project specific responsibilities, i.e. Clinical Management for smaller or less complex studies, under the appropriate supervision of the line manager or functional lead
• Other activities as designated

• 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
• Previous clinical research experience desired
• Knowledge of ICH-GCP/ISO14155, FDA Guidance Documents, EU Directives, local/regional regulations, and drug/device development and clinical monitoring procedures
• Knowledge of clinical/health systems as well as knowledge of cultural/professional practices appropriate to the country/region where site monitoring activities will be conducted
• Knowledge of web-based communication tools for conferences and any other IT systems required for the job
• Excellent communication and collaboration skills; maintains a team player attitude; uses a common-sense approach to solving issues/problems
• Excellent organizational and time-management skills, able to meet deadlines
• Ability to multitask and work effectively in a fast-paced environment with changing priorities, self-starter
• Accountable, dependable, and maintains a strong commitment to producing quality work
• Applies clear and consistent performance standards and handles issues/problems decisively and objectively
• Maintains a positive, results-orientated work environment
• Customer service focused in approach to work, both internally and externally
• Full-time availability to internal and external project team members
• Strong verbal and written communication skills
• Read, write and speak fluent English; fluent in host country language
• Travel: 70-85%
• Lifting up to 25lbs
• Valid driver's license, passport as required