Clinical Research Associate - Sponsor Dedicated (Medical Device)

About the position

The Clinical Research Associate (CRA) - Sponsor Dedicated role at IQVIA involves monitoring and managing clinical trial sites for medical devices. This position is crucial for ensuring compliance with regulatory requirements and maintaining high-quality standards throughout the clinical research process. The CRA will engage in site selection, initiation, monitoring, and close-out visits, while also driving subject recruitment and providing training to site staff. This role is pivotal in supporting the execution of clinical trials and ensuring successful project outcomes.

Responsibilities

• Embark on site monitoring adventures including selection, initiation, monitoring, and close-out visits in line with contracted scope of work and regulatory requirements.
• Drive and track subject recruitment plans with sites, ensuring project needs are met with precision and predictability.
• Lead protocol and study training sessions for assigned sites, establishing strong communication channels to manage project expectations and swiftly address issues.
• Evaluate and ensure the highest quality of study site practices, maintaining strict adherence to protocols and regulations.
• Oversee the progress of studies by tracking regulatory submissions, approvals, recruitment, enrollment, case report form (CRF) completion, and data query resolution.
• Maintain meticulous documentation for the Trial Master File (TMF) and verify the Investigator's Site File (ISF) is up to standard with GCP/ICH and local regulatory requirements.
• Create comprehensive reports on site management, monitoring visit findings, and action plans.
• Mentor and inspire clinical staff, conducting co-monitoring and training visits to share knowledge and expertise.
• Collaborate seamlessly with study team members to support project execution and ensure success.
• Develop and manage subject recruitment plans on a per-site basis, if applicable.
• Handle site financial management according to clinical trial agreements and retrieve invoices as per local requirements, if applicable.

Requirements

• Bachelor's Degree in a scientific discipline or health care preferred.
• At least 11 months of on-site monitoring experience required.
• Expert knowledge of clinical research regulatory requirements, including GCP and ICH guidelines.
• Strong therapeutic and protocol knowledge as provided in company training.
• Proficiency in Microsoft Word, Excel, and PowerPoint, and adept at using laptops and mobile devices (iPhone and iPad where applicable).
• Excellent communication skills, both written and verbal, with a good command of the English language.
• Outstanding organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to build and maintain effective relationships with coworkers, managers, and clients.

Benefits

• Health insurance
• 401k plan
• Paid holidays
• Professional development opportunities
• Flexible scheduling