Regional Clinical Research Associate

Remote Regional Clinical Research Associate – Perm - $115,000 - $125,000
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 Remote Regional Clinical Research Associate

Role Description

The Clinical Research Associate plays a vital role in the Clinical Operations team. Through responsibilities like monitoring studies, reviewing data, and engaging with sites, the CRA will ensure the success of clinical trial operations and management.

• Monitoring clinical studies of investigational and approved products that have been determined to satisfy a medical need and/or offer a commercial benefit. This may include the following site visits: qualification, initiation, interim, and close out
• Managing and training of site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion
• Managing, preparing, sending, tracking, and returning investigational supplies at individual sites
• Monitoring and documenting investigational product dispensing, inventory, and reconciliation
• Monitoring and documenting laboratory sample storage and shipment
• Monitoring trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, and laboratory abnormalities
• Reviewing source data and case report forms for accuracy, completeness, and integrity of the data, and identifying and resolving ongoing data issues
• Reviewing data queries and listings, and working with the study centers to resolve data discrepancies
• Reviewing regulatory documentation for accuracy and completeness, and supporting study centers with regulatory issues
• Maintaining complete and accurate study files and reviewing files to ensure all appropriate documentation is present
• Maintaining consistent and timely contact with the study centers, investigators, coordinators, client personnel, and other individuals involved in clinical trials.
• Following Good Documentation Practices, completing Visit Reports and site correspondence in accordance with SOPs

Skills & Requirements

• Detail oriented
• Excellent organizational skills, strong interpersonal and communications skills, and strong problem-solving skills
• Flexibility with changing priorities
• Ability to efficiently perform and prioritize multiple tasks
• Familiarity with medical and pharmaceutical industry, and related terminology and practices
• Extensive knowledge of FDA regulations and their practical implementation
• Ability to travel, including by air or by car on short notice
• A valid driver's license with access to a car with up-to-date car insurance
• Computer proficiency in Microsoft Word, Excel, and PowerPoint

EDUCATION AND/OR EXPERIENCE
• Bachelor and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education, or training
• 2 years of prior experience as a Clinical Research Associate preferred

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the 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 including disability/veteran.

In accordance with applicable federal and state law protecting qualified individuals with known disabilities, Hays U.S. Corporation will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570

Drug testing may be required; please contact a recruiter for more information. #1143134

Summary

Job Type
Permanent
Industry
Pharmaceuticals
Location
Remote
Specialism
Pharma
Pay
115,000 - 125,000
Ref:
1143134