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 30-50% - domestically
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