Clinical Research Associate
2 days ago
As a Senior Field Clinical Research Associate, you will be responsible for monitoring clinical studies at sites in an assigned territory to ensure compliance with applicable regulatory requirements, Good Clinical Practice, and accuracy standards.
You will ensure both regulatory and clinical protocol compliance is maintained for all assigned clinical projects, including reviewing data and source documentation from investigational sites, ensuring adverse events and protocol deviations are reported, and resolving problems.
You will also coordinate with study teams, field clinical engineers, and specialists to enroll sites into new and ongoing clinical studies, facilitate enrollment of study subjects, and resolve data queries and action items at clinical sites.
Additionally, you will promptly report the findings of monitoring visits, collaborate with in-house teams to ensure complete submission of study documents, and participate in conference calls and training sessions.
You will also train site personnel to ensure compliance with the study protocol and local regulations, mentor less experienced clinical team members, and demonstrate strong written and verbal communication skills with internal and external customers.
", "Minimum Qualifications": "A Bachelor's degree from an accredited university or college, preferably with an academic focus in natural science, pre-medicine, nursing, bioengineering, or a related academic field.
Superb understanding of all aspects of clinical research, minimum five years clinical research experience, and strong written and verbal communication, interpersonal, presentation, analytical, organizational skills.
Ability to interpret basic clinical data, meet deadlines, and communicate effectively with all levels of employees.
Basic personal computer skills, including a working familiarity with word processing software and relevant clinical applications.
Ability to work independently and function within a dynamic, global team environment.
", "Preferred Qualifications": "Strong preference for prior clinical monitoring experience, general familiarity with cardiac, vascular, and/or neuromodulation technologies, and previous related experience in a medical device/pharmaceutical company or relevant clinical experience in a clinical/hospital environment.
Certification by an industry-recognized professional society, such as the Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP).
", "Company": "Medasource"}-
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