Clinical Research Associate II

Job Summary
JOB DESCRIPTION
The Clinical Research Associate II (CRA II) is developing professional expertise, applying policies and procedures to resolve a variety of projects. Involved with more complex tasks and requires a deeper understanding of clinical trial processes, regulatory requirements, and project management. Responsible for clinical studies, site management and compliance monitoring of assigned clinical projects undertaken in support of a given product line or marketing initiative. This position must ensure that all activities will be conducted in accordance with Government Regulations (FDA, MDD and International), Good Clinical Practices (GCP) and Department Operating Procedures (DOP).

Duties & Responsibilities

• Works on projects of moderate scope where analysis of situations or data requires a review of a variety of factors.
• Exercise judgement with defined procedures and practices to determine appropriate action.
• Plan, implement and conclude clinical studies in support of project timelines/market release goals with minimal supervision. An advanced individual may conduct more complicated studies, as well as contribute to study proposals and protocols, applying principles of clinical study design and research methodology to assigned research projects.
• Prepares and documents study plans, contracts, budgets, informed consents, IRB submissions, case report forms (CRFs), and other study related materials to assure quality, consistency, compliance, organization, storage and accuracy across all assigned projects.
• Contribute to clinical study design, proposals, protocols, etc., understanding basic scientific content, experimental design, and analytical approaches used.
• Effectively work and communicate with investigator, staff and patients in professional, sensitive and mature manner.
• Conduct site monitoring (qualification, initiation, periodic monitoring and close out visits) to ensure and document site is trained to follow study procedures per protocol.
• Monitor safety reviews and adverse event reporting for investigational medical devices to assure adherence to Good Clinical Practices (GCP), FDA and MDD regulations.
• Ensure identification and reporting of safety issues (e.g. Adverse Events, Serious Adverse Events, Unanticipated Adverse Device Effects, etc.).
• Ensure accountability of Investigational Devices and study supplies are performed, when appropriate to the study;
• Perform monitoring activities per Clinical Investigational Plan (e.g. verification of source documents and CRFs, maintain site communications, perform follow up activities on issues noted, etc.).
• Ensure complete reporting and proper documentation of monitoring activities (e.g. complete monitoring reports in a timely manner, follow up with sites to complete open action items, etc.).
• Ensure sites are identifying issues and implementing corrective and preventative actions to ensure inspection readiness.
• Suggest improvements to departmental procedures relating to GCP monitoring aspects.
• Understands and operate Masimo products, data acquisition systems, following best practices for execution of study protocol and use of equipment.
• Ensure essential study documents are accurate, complete, and properly organized and stored as quality records.
• Conduct basic data analysis using spreadsheets, preparing basic calculations, statistics, graphs and tables.
• Writes clear, succinct and detailed clinical study and technical summary reports.
• Conduct full range of data collection duties, including equipment setup and operations, execution of study per procedures, collect data, verify results and