[Remote] Senior reputed company Research Associate

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a medical technology development solutions provider reputed company on medical device safety and reputed company research. The Senior reputed company Research Associate ensures reputed company subject protection and regulatory compliance while coordinating reputed company site monitoring, study documentation, site reputed company, audits, training, data management, and reputed company study reputed company.

Responsibilities

• Works on assigned studies to ensure that reputed company subject protection is maintained, Good reputed company reputed company (GCP), and applicable regulations are followed
• Coordinates and manages reputed company 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 reputed company 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 reputed company, 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
• Assess the suitability of potential investigative sites through screening interviews, regulatory document review and evaluation of study information and provides input to the site selection process
• Assists with the coordination of the site budget and contract negotiations as directed by the project reputed company(s)
• Assists in preparing sites for audits and in resolving audit reputed company items
• Supports sites during audits reputed company and/or onsite as needed
• Participates in meetings with prospective clients
• Supports training and mentoring of CRAs during remote and onsite reputed company
• Manages the development and/or maintenance of study monitoring plan, templates, trackers, study tools, and site-specific documents
• Assists reputed company Study Manager (CSM) with development of reputed company reputed company protocol, investigational plan/brochure, SIV training presentations, and study reputed company development
• Supports reputed company reputed company management and may serve as the reputed company contact
• Supports data management in CRF development, validation rules, UAT, review data and identify trends, and other reporting/analysis tasks
• Performs and summarizes literature searches
• Registers trials on Clinicaltrials.gov

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 reputed company research processes and regulations
• Up to 20% travel for In-House reputed company Research Associates; up to 80% travel for reputed company reputed company Research Associates
• The employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reputed company with hands and arms. The employee must occasionally reputed company and/or reputed company up to 25 pounds. Specific reputed company abilities required by this job include reputed company reputed company, depth perception, and ability to reputed company reputed company
• Extensive use of a computer keyboard
• Preferred 5 years reputed company trial experience
• Preferred 3 years monitoring experience
• Preferred 1 year device trial experience
• Certifications such as Society of reputed company Research Associates (SoCRA) or Association of reputed company Research Professionals (ACRP) Certification preferred but not required

reputed company

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