Senior Clinical Research Associate
2 weeks ago
Position Summary
The Sr. Clinical Research Associate is responsible for leading, assisting, and providing monitoring and site management support for clinical sites during study start-up, enrollment, maintenance, and close-out.
Responsibilities
- Lead or support assigned clinical trial sites(s) during start-up, ongoing activities, close-out, and reporting.
- Assist with the review of study-related and essential clinical study start-up documents including but not limited to Clinical Protocols, Informed Consent Form, Monitoring Plans, Case Report Forms (CRFs), and Site Training Materials.
- Conduct or assist in site visits including Site Qualification, Site Initiation, Interim Monitoring, and Close-Out Visits.
- Train study site personnel to study conduct, protocol, and database.
- Ensure sites are entering data, responding to data queries, and closing out action items in a timely fashion.
- Prepare confirmation and close-out letters and study visit reports.
- Review site essential documents to maintain high quality, audit-ready study documentation.
- Identify and escalate site issues and challenges to the study team; propose and implement solutions to prevent issues from occurring again and ensure inspection readiness.
- Suggest improvements to process, procedures and documents relating to monitoring.
- Establish and maintain relationships with investigational study sites.
Compliance & Legal Responsibilities
- Maintaining the highest standards of ethics in all circumstances
- Ensuring respect of Good Clinical Practices and General Data Protection Regulation
- Ensuring compliance with the Company quality system and all applicable guidance, standards and regulations.
Position Requirements
- Necessary skills and experience:
- Minimum of 5 years of clinical site monitoring experience with regulated clinical research studies particularly during the study start-up phase and ideally involving investigational medical devices.
- Excellent planning, organizing, problem-solving, and execution skills with the ability to appropriately initiate and escalate.
- Demonstrated experience independently developing monitoring related tools and plans.
- Proficient in electronic data capture (EDC) systems and navigating Electronic Health Records (HER).
- Experience working in various sized organizations, including a small start-up environment.
- Excellent verbal and written communication abilities, at all levels of the organization and external partners.
- Team player with a willingness to help where needed and work with a diverse team.
- Ability to travel within the United States for site visits up to 60% time; must be located near a major airport.
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