Clinical Research Monitoring (CRA)

Clinical Research Associate job at Custom Search Inc. 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.

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

Data review and query resolution

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

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

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

Ability to travel up to 30-50% - domestically

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