Job Description

Our start-up, clinical-stage medical device client, is adding a Clinical Research Associate to the team. The CRA will support operational activities related to the organization's sponsored clinical research programs. Primary responsibilities will be the start-up and management of assigned clinical sites and task and projects related to the preparation and administration of US and OUS clinical trials, including (but not limited to) the development of study materials, site training materials, clinical quality system documents, device accountability management, site initiation, data review and DCF resolution, and ensuring protocol compliance of sites and vendors.

Your role with the company:

• Work closely with the supervisor to ensure that departmental objectives are met.
• Act as primary point of contact for assigned clinical sites, labs, and vendors.
• Manages assigned clinical sites by partnering with Field Team, monitors and site staff to identify and resolve issues and maintain compliance
• Ensures timely collection of study documentation of assigned sites by obtaining, maintaining, and updating (if applicable) said documentation
• Review source documentation to ensure accurate and timely reporting of data and adverse event
• Routinely reviews site data and regulatory status for compliance to the protocol and works to identify and correct any compliance issues or risks to compliance
• Participates in the preparation and implementation of monitoring activities, partnering with colleagues to ensure timely closure of monitoring activities at assigned sites
• Management of imaging data and device accountability systems
• Development and implementation of site training materials and study documents
• Prepares site materials, such as study, patient, and training binders
• Specific duties may include:
• Data review and query resolution
• Device accountability management
• Monitoring preparation and responsibilities
• Assist in qualification of investigators to conduct trials, including evaluation and conduct of pre-study site visits and site initiation visits
• Site training and initiation visits
• Review of informed consent documents, investigator brochures, case report forms, study manuals and other study related tools
• Assist with the negotiation of agreements
• Monitor data to ensure accuracy, thoroughness and regulatory compliance of clinical documentation
• Field Support
• Responds to customer needs and complaints regarding products and service by developing solutions or working with other related personnel (e.g. quality, research and development, regulatory) to develop optimal solutions
• Physician and Staff Training
• Support site education regarding clinical usage of company products
• Participate in periodic journal reviews, case reviews and clinical observations

Desired Profile:

• Bachelor's degree in a scientific related discipline, life sciences, engineering, or related field.
• Minimum of 2-3 years of experience in a regulated environment as a Clinical Research Associate
• Experience with implantable cardiology related products and technologies preferred
• Knowledge of FDA/EU regulations and Good Clinical Practices essential
• Outstanding organizational skills, flexibility and attention to
• Ability to travel up to 50% - domestically

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