Senior Clinical Research Associate in United States at Jobgether

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Senior Clinical Research Associate in the United States.

This role plays a key part in the successful execution of clinical studies for medical devices, ensuring compliance with Good Clinical Practice (GCP), regulatory requirements, and study protocols. You will oversee site monitoring activities across multiple clinical trials, acting as a primary liaison between study sites and internal project teams. The position involves both on-site and remote monitoring responsibilities, including site qualification, initiation, interim monitoring, and close-out visits. You will contribute to study start-up, data quality oversight, and regulatory documentation while supporting clinical operations throughout the product development lifecycle. Working in a highly collaborative, science-driven environment, you will help ensure the integrity of clinical data and the protection of human subjects. This role is ideal for an experienced clinical research professional who thrives in a fast-paced, regulated environment and enjoys working across multidisciplinary teams.

• Conduct clinical site monitoring activities including qualification, initiation, interim, and close-out visits (on-site and remote) to ensure compliance with protocols and regulations.
• Ensure protection of human subjects and adherence to Good Clinical Practice (GCP) and applicable regulatory requirements.
• Serve as the primary point of contact for clinical sites regarding study conduct, enrollment, and operational issues, coordinating with internal teams as needed.
• Support study start-up activities, including document review, site activation, and training of site personnel.
• Track site performance and study metrics such as enrollment, deviations, adverse events, and overall data quality.
• Maintain and ensure completeness of essential study documentation, including site files and regulatory records.
• Assist with audit preparation and resolution of findings, supporting both remote and on-site inspections.
• Contribute to study management activities such as CRF development, data review, trend identification, and clinical documentation.
• Participate in investigator meetings, client discussions, and cross-functional project meetings.
• Support regulatory submissions outside the United States and assist in global clinical trial operations.
• Provide mentorship and support to junior clinical research staff when required.
• Assist in literature reviews, trial registration activities (e.g., ClinicalTrials.gov), and additional clinical operations tasks as assigned.

• Bachelor’s degree or equivalent combination of education and relevant clinical research experience.
• Minimum of 5 years of clinical trial experience, including at least 3 years in clinical site monitoring (preferred).
• Experience in medical device clinical trials is highly desirable.
• Strong understanding of clinical research processes, Good Clinical Practice (GCP), and applicable regulatory frameworks.
• Ability to work independently while managing multiple studies and priorities.
• Excellent communication skills, both written and verbal, with strong interpersonal abilities.
• Strong organizational skills and attention to detail in documentation and compliance activities.
• Proficiency with standard computer tools and clinical systems.
• Willingness to travel significantly depending on role type (up to 80% for field-based roles).
• Certifications such as ACRP or SoCRA are considered an advantage but not required.

• Competitive compensation package aligned with experience and market standards.
• Comprehensive health, dental, and vision insurance coverage.
• Retirement savings plan and financial wellness programs.
• Paid time off and flexible work arrangements depending on assignment.
• Opportunity to work on innovative medical device clinical trials with global impact.
• Career development opportunities in a highly specialized clinical research environment.
• Exposure to global regulatory and multi-site clinical study operations.
• Supportive, science-driven culture focused on quality and patient safety.