Clinical Research Associate

Assist the activities involving clinical research and post-market clinical follow-up studies.

Essential Job Functions

• Support and implementation of clinical research and post-market clinical follow-up studies activities.
• Qualifying clinical study sites and conducting site visits
• Perform data audit and collaborate with the clinical sites
• Assist Clinical Affairs Manager in writing/updating the clinical investigation reports.
• Assist Clinical Affairs Manager in performing clinical evidence gap analysis and develop strategy for clinical data collection.
• Oversee data collection and documentation and inputting data into the system databases.
• Provide status updates to Clinical Affairs Manager and Senior Vice President, Quality and Regulatory Affairs regarding the on-going clinical studies.
• Interact with clinician consultants for clinical protocol development, data collection, new product development, and customer feedback surveys.
• Interact with distributor customers for clinical data collection, publications, post-market surveillance information.
• Knowledge of IRB and GCP guidelines and standards
• Willing to travel

Competencies

• Meaningful Innovation
• Ownership/Accountability
• Pace/Efficiency
• Teamwork/Collaboration
• Integrity/Ethical Practice
• Resilience/Grit

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel objects, tools or controls; reach with hands and arms; climb stairs; talk or hear. The employee must occasionally lift or move office products and supplies, up to 50 pounds.

Education, Experience And Certification

• Bachelor Degree in biological sciences or related discipline with at least 1- 2 years of experience in clinical research or similar field.
• Ability to follow written and oral instructions with minimum supervision.
• Good communication skills, both verbal and written.
• Knowledge of standards, guidelines and norms for product development (ISO, MDR and FDA guidelines) and for clinical studies (Good Clinical Practice) is essential.
• Good interpersonal skills and communication skills for internal and external contacts.

Other Duties As Required

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.