The Clinical Research Associate II plays a critical role within the Clinical Affairs department, responsible for site management and/or monitoring activities during clinical trial execution. This position involves working under moderate supervision to ensure compliance with study protocols and regulatory standards. The CRA II plays a pivotal role in maintaining the integrity of clinical data while adapting to the dynamic needs of different studies.

Company Profile

Client is a smaller medical device company that provides innovative technologies for the treatment of Atrial Fibrillation.

Key Responsibilities:

Site Management:

• Coordinate the collection and review of essential documents from clinical investigation sites in collaboration with study team personnel.
• Support site Qualification, Initiation, Interim and Close-Out training visits.
• Assist with scheduling of required training sessions (e.g., EDC, Protocol, Device) and support site nomination and qualification processes.

Site Communications:

• Serve as the main point of contact for site communications and inquiries.
• Liaise with clinical study management, clinical development, site personnel, and CROs, escalating protocol or study related issues as necessary.

Compliance:

• Ensure clinical study sites adhere to assigned study protocols and regulatory standards, notifying study management of any concerns.

Data Management:

• Review and analyze data for accuracy and completeness.
• Manage the creation, resolution, and tracking of data queries.

Monitoring:

• Conduct site monitoring visits (qualification, initiation, interim, and close-out) to ensure adherence to study procedures and regulatory requirements.

Safety:

• Process product complaints and adverse events as reported, collaborating with safety specialists to gather necessary materials for CEC meetings.

Study Management:

• Assist in the development of study-related materials, including patient recruitment materials and newsletters.
• Facilitate ordering of clinical study devices, including verification and tracking of the devices to ensure proper receipt and storage at study sites.
• Coordinate activities with study-specific committees, vendor services, and core labs.

Other Duties:

• Ensure appropriate translations for study documents.
• Contribute to process improvement initiatives and department activities.

Leadership & Development:

• Focus on self-development with opportunities to mentor entry-level professionals.
• Engage in continuous learning and professional development in clinical research areas.

Qualifications and Experience:

• Bachelor’s degree with a minimum of 2 years of clinical research experience.
• Strong organizational and communication skills with an ability to work effectively in a team.
• Proficiency in Microsoft Office Suite and familiarity with clinical data management systems.
• Willingness to travel 25% of the time.

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