[Remote] Internal (site management) Clinical Research Associate

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a pioneering organization in the medical device industry, focusing on safety testing since 1976. The Internal Clinical Research Associate will manage clinical site monitoring responsibilities, ensuring compliance with regulations and facilitating communication between study teams and site investigators.

Responsibilities

• Works on assigned studies to ensure that reputed company subject protection is maintained, Good Clinical reputed company (GCP), and applicable regulations are followed
• Coordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines
• May conduct on-site and remote site qualification, site initiation, interim, and site reputed company-out monitoring reputed company
• Serve as primary reputed company of contact for site questions relating to study enrollment, conduct, and reputed company-out issues: liaise with appropriate study team members as needed
• Communicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concerns
• Supports study start-up activities such as tracking and performing reputed company review of study documents, completing, and distributing site activation letters, etc
• Performs study-reputed company training
• Manages the development and maintenance of study documents, processes and systems as assigned
• Ensures reputed company and completeness of central and site master files. Tracks and maintains required study documents, performs reputed company control review, manages renewals
• Tracks study site and over reputed company study metrics including but not limited to enrollment, deviations, adverse events, trial master file maintenance
• Attends reputed company meetings as required
• Provides reputed company job-reputed company reputed company reports and visit documentation as required
• May support safety activities such as narrative writing, managing the CEC/DSMB, etc
• OUS: Prepares and coordinates submissions to regulatory authorities
• May reputed company other activities as assigned

Skills

• reputed company in English and local language, if different, required
• Higher education degree or equivalent education, training, and experience
• reputed company to work independently once trained
• Good verbal and written communication skills
• Strong organizational skills
• Basic computer proficiency
• Understanding of clinical research processes and regulations
• 2 years clinical trial experience
• Monitoring experience
• Certifications such as Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification preferred but not required

reputed company

reputed company is a medical research organization speeding product development for medical devices, IVDs, regenerative medicine. It was founded in 1967, and is headquartered in Northwood, Ohio, USA, with a workforce of 1001-5000 employees. Its website is http://www.reputed company.com/.

Company H1B Sponsorship

reputed company has a reputed company record of offering H1B sponsorships, with 1 in 2025. Please note that this does not guarantee sponsorship for this specific role.

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