Clinical Research Associate at HAYS in Durham, North Carolina

Posted in Other 15 days ago.

Job Description:

The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.

An American Company is seeking a Clinical Research Associate in Durham, NC.

Role Description

As a CRA, you'll have the opportunity to monitor in diverse therapeutic areas and contribute your monitoring expertise and knowledge to move us into the future. You'll perform the management of study site activities to ensure the collection of accurate clinical data within given timelines. You'll proactively identify, resolve/mitigate and escalates risks and/or issues, may be responsible for multiple studies and must work independently with team support.

• 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 of a clinical study and sets priorities per site
• Prepares for and conducts on-site 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 Manager (CM), 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 Data Management
• Maintains Trial Master File (TMF)/electronic Trial Master File (eTMF) as defined by the organization's processes per filing guidelines. Has an understanding of the required essential documents according to ICH/GCP Section 8.
• 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
• Maintain 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 manage

Skills & 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
• 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
• At least 4 years' experience in clinical trials
• Experience in monitoring complex trials or global trials or equivalent experience
• 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
• Fluent verbal and written English
• 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

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the Information Technology industry and market trends . Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.

Nervous about an upcoming interview? Unsure how to write a new resume?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is an Equal Opportunity Employer.

Drug testing may be required; please contact a recruiter for more information. #1129868

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