Clinical Research Associate

Purpose

The Clinical Research Associate plays a crucial role in managing the operational aspects of clinical trials across investigational sites, ensuring compliance with regulatory standards and Good Clinical Practice (GCP). This position supports multiple clinical studies in various therapeutic areas by monitoring site performance, addressing challenges, and maintaining communication between sponsors and site staff.

Responsibilities

• Assess requirements for clinical trial site qualification (SQVs), training (SIVs), monitoring (IMVs), and ongoing support.
• Simultaneously manage activities across several trial sites and studies covering diverse medical indications.
• Create and implement monitoring plans tailored to assigned clinical trials.
• Coordinate with external clinics or hospitals and their investigative teams to ensure trial and monitoring standards are met from initiation to completion.
• Manage trial site setup, ensuring availability of all necessary materials for conduct of the study.
• Oversee site activation procedures for each clinical study.
• Establish and track metrics to assess monitoring and site performance, addressing any issues proactively to mitigate risks.
• Regularly review clinical data to detect inconsistencies or potential data collection problems.
• Monitor patient recruitment and advise site staff on strategies to optimize enrollment of eligible candidates.
• Support resolution of data queries, deviations, and adverse event processing.
• Prepare detailed monitoring visit reports.
• Develop and execute comprehensive site close-out plans following study completion.
• Ensure strict adherence to ICH-GCP guidelines, SOPs, IRB regulations, and study protocols.
• Maintain regulatory compliance in accordance with FDA regulations and organizational SOPs at investigational sites.
• Collaborate with data management teams to coordinate trial data activities.
• Draft clinical protocols and informed consent documents for managerial evaluation.
• Conduct literature reviews for emerging study indications.
• Assist with development of Case Report Forms (CRFs) and organization of investigator meetings.
• Create data tables and presentation materials summarizing study status for executive leadership.
• Maintain comprehensive investigator binder files throughout the study lifecycle.
• Stay current with regulatory requirements including FDA 21 CFR 1271 & 820, AATB, ISO standards, and cGMP/CGTP guidelines.
• Demonstrate punctuality and consistent attendance during scheduled work hours and meetings.
• Exhibit flexibility to work beyond regular hours, including evenings or weekends, with appropriate notice to fulfill business demands.
• Perform additional duties as required.

Qualifications and Skills

• Bachelor’s degree in Clinical Research, Life Sciences, or related discipline.
• Certification as a Clinical Research Associate (e.g., CCRA, CCRP) highly preferred.
• Minimum three years’ experience in clinical research within industry or as a clinical coordinator with sponsor companies.
• Proven supervisory experience in clinical study oversight.
• Ability to pass a comprehensive background check.
• Valid Class C driver’s license.
• Willingness and ability to travel up to 50% of the time.
• Solid knowledge of ICH-GCP, FDA regulations, and clinical research methodologies.
• Strong organizational skills and attention to detail with problem-solving aptitude.
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint).
• Excellent written and verbal communication capabilities.
• Ability to thrive both independently and within collaborative team environments.
• Capacity to handle multiple sites and travel requirements efficiently.