Senior Clinical Research Associate

Our client, a leading life sciences company, is seeking a Sr. Field Clinical Research Associate for a remote, travel-based, part-time 12-month contract position focused on the North Central Region, with the possibility of extension. In this hybrid role, you will be responsible for monitoring clinical studies at assigned sites to ensure compliance with regulatory requirements, Good Clinical Practice (GCP), and study protocols. You will play a key role in site initiation, periodic and close-out visits, data and documentation review, adverse event and protocol deviation reporting, and resolution of site issues. The position involves close coordination with study teams, enrolling sites and subjects, facilitating data query resolution, and mentoring junior team members. This is an excellent opportunity for an experienced clinical research professional with a strong background in cardiac, vascular, or neuromodulation technologies.

WHAT YOU'LL DO

Monitor clinical studies at sites in your assigned territory (and others as requested) to ensure compliance with regulatory requirements, Good Clinical Practice, and study protocols, including site initiation, periodic, and close-out visits. Ensure both regulatory and clinical protocol compliance is maintained for all assigned clinical projects. Review data and source documentation from investigational sites for accuracy and completeness. Ensure timely and accurate reporting of adverse events, protocol deviations, device complaints, and malfunctions according to company policies and procedures. Resolve and/or facilitate resolution of site issues, including identification of root causes and actions to prevent recurrence. Coordinate with study teams, field clinical engineers, and specialists to enroll sites into new and ongoing clinical studies. Facilitate enrollment of study subjects via site coordinators and support resolution of data queries and action items at clinical sites. Promptly report findings of monitoring visits according to established processes. Collaborate with in-house teams to ensure complete and timely submission of study documents. Participate in conference calls and training sessions as required. Train site personnel to ensure compliance with study protocols and local regulations. Mentor less experienced clinical team members as requested. Demonstrate a high level of written and verbal communication skills with internal and external customers.

WHAT YOU BRING

Bachelor’s degree from an accredited university or college, preferably in natural science, pre-medicine, nursing, bioengineering, or a related field. Minimum six years of clinical research site monitoring experience with a superb understanding of all aspects of clinical research. Experience with cardiovascualr medical device trials Strong written, verbal, interpersonal, presentation, analytical, and organizational skills. Ability to interpret basic clinical data, meet deadlines, and communicate effectively with all levels of employees. Proficiency with word processing software and relevant clinical applications. Ability to work independently and within a dynamic, global team environment. Ability to exchange straightforward information, ask questions, and check for understanding. Familiarity with cardiac, vascular, and/or neuromodulation technologies. Prior clinical monitoring experience (strongly preferred). Experience in a medical device/pharmaceutical company or clinical/hospital environment (preferred). Certification by an industry-recognized professional society (e.g., SoCRA, ACRP) or accredited institution (preferred). #J-18808-Ljbffr Medasource