Clinical Research Associate

Proclinical is working with a leading medical device company in search for a remote Clinical Research Associate. As the Research Associate, you will oversee and support the conduct of clinical studies, with a primary focus on the conduct of on-site and remote clinical site monitoring and centralized data review.

Job Responsibilities:

• Conduct site visits (SQV, IMV, COV) as required per Monitoring Plan to perform source data/document verification
• Conduct centralized data review activities to identify potential outliers and discrepancies and communicate with sites to resolve data discrepancies and queries
• Identify and assess suitability of clinical study sites and investigators
• Clinical study product and material accountability
• Close out clinical study sites on completion of the study
• Prepare site subject binders, study visit documents and PowerPoint presentations
• Maintain study requirements for posting to clinicaltrials.gov
• Maintain and update clinical study management systems as needed
• Maintain completeness of site documents in trial master file
• Able to assist in the creation and maintenance of the study annual budget
• Able to create and edit a study report (annual or ad hoc) as needed
• Assist other team member participating in the cross-training opportunities with study-related activities
• Works with team members to identify process improvements
• Participate in regional and global process improvement initiatives
• Maintain standard operating procedures
• Actively participates in departmental and business unit meetings and scheduled activities
• Willing to assist and mentor other team members
• Ability to effectively identify and resolve conflicts and disagreements regarding clinical research matters
• Impacts project teams and business units through quality work and leadership of projects or portions of projects

Skills and Requirements:

• Bachelor's Degree (or non-US equivalent), required. Concentration in nursing, life sciences, engineering or other medical sciences preferred
• A minimum of 3 years of applicable experience required, including a minimum of 1 year of field monitoring experience
• Established knowledge of Good Clinical Practice (GCP) and local government-related guidelines and regulations
• Clinical Research Professional certification is preferred
• A combination of education and experience may be considered

If you are having difficulty in applying or if you have any questions, please contact Mary Jacobs at (+1) 267-297-3376 or m.jacobs@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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