Clinical Research Associate

Please note: This role requires onsite support and regular travel to clinical sites . This is not a fully remote position . Please apply only if you are comfortable with frequent travel requirements. Title: Consultant, CRA, Medical Device Contract to hire role. Locations: 3 CRAs: Northeast (between PA and MA, including NY, NJ Mid/Southwest (TX to UT) Midwest (IL/Chicago) 5-7 sites per region Client Overview BioBridges, a Career Portfolio Management company servicing the drug, device, and biologic development community, is supporting a client with a need for a CRA with IDE study expertise. Client Business Driver Our client is a mid-size, private, global medical device company pioneering innovative neurovascular solutions to treat complex diseases such as stroke, aneurysms, and arteriovenous malformations The Work The Clinical Research Associate will conduct on-site or remote visits to assess site adherence to protocol and regulatory requirements and manages required documentation. They will also be responsible for ensuring the patient and site data remains audit ready and able to pass an audit by client, the Sponsor or a regulatory agency. Develop strong relationships with sponsors and sites and be a part of a multi-disciplinary team that provides scientific, statistical, operations, and management support for commercially or nationally funded clinical trials. Key Responsibilities: Lead and oversee complex studies, guiding study planning, execution, and close-out. Contribute to and oversee the design of clinical study protocols, case report forms, and consent forms. Select and initiate study sites suitable for conducting clinical trials. Establish and maintain strong relationships with study site staff, training them as needed on protocol and regulatory requirements. Conduct comprehensive site initiation, monitoring, and close-out visits to ensure adherence to the study protocol, GCP, and regulatory requirements. Review and approve study site's investigational drug accountability, safety event documentation, and protocol deviations or violations, providing corrective action guidance as needed. Ensure complete and accurate patient files, informed consent, case report forms, and source documents; identify and address any deficiencies. Ensure the maintenance of study site documentation to ensure audit readiness. Oversee the resolution of data queries, identifying patterns and providing training to sites to reduce the recurrence of common errors. Mentor, train, and co-monitor junior team members to enhance their clinical research capabilities. Assist in the development and revision of the company's Standard Operating Procedures to ensure alignment with industry best practices. Develop and update document templates, including but not limited to Monitoring Plans, Monitoring Visit Reports, Confirmation Letters, Follow-Up Letters, and Query Logs. Address protocol or monitoring-related questions received from clinical sites promptly and accurately. Participate in and contribute to the planning and execution of investigator meetings and other external or internal meetings as required. Review and validate clinical study data, ensuring its completeness, accuracy, and consistency. Provide feedback to assist sites with a resolution of detected deficiencies and corrective action needed. Identify, document, track, and report site protocol deviations and violations as defined within the EAP Monitoring Plan Qualifications: Bachelor’s degree in Life Sciences, Nursing, Biomedical Engineering, or a related field. Minimum of 5 years in IDE Study Experience within the medical device industry. Extensive experience coordinating on-site and remote monitoring visits. Proficiency in Clinical Trial Management Systems (CTMS) and Electronic Data Capture (EDC) tools. Ability to travel to sites regularly to monitor study progress, ensure protocol compliance and address any issues or concerns Highly proficient organizational and logistical skills to ensure effective management of multiple sites and protocols within timeframes and on budget Preferred Skills: Advanced degree in Life Sciences Experience with neurovascular devices, interventional cardiology, and or endovascular is highly desirable. Expected Commitment This role will be about 4 days on site per month and equate to .5 FTE., but has the potential to convert to a full-time employee (FTE).