Kunal Suthar

Background

About Kunal Suthar

I am experienced Clinical Research Associate with over a decade of hands-on experience in all phases of clinical trials (I–IV), including site qualification, initiation, monitoring, and close-out. My background spans across therapeutic areas such as diabetes, gastrointestinal disorders, glaucoma, obesity, and medical devices, with a consistent focus on patient safety, protocol compliance, and data integrity. My core competencies include protocol and document review, site file and trial master file audits, adverse event reporting, risk-based monitoring, informed consent verification, recruitment support, and issue resolution. I am proficient in using CTMS and EDC tools for streamlined project management. I am also certified by VIARES and LinkedIn in oncology monitoring and resume optimization. I am passionate about advancing healthcare and patient safety through collaborative and patient-focused research. I am a team leader and a mentor, with exceptional communication and supervision skills. I am always eager to learn new skills and update my knowledge to stay ahead of the curve in the fast-changing clinical research landscape. Having worked in both on-site and remote monitoring roles, I bring a deep understanding of risk-based monitoring strategies, regulatory documentation (including TMF & site files), and EDC systems such as Octalsoft, Clindox, and IWRS. I am fully certified in GCP, TCPS 2, and hold advanced CRA certifications from CCRPS and VIARES. Now based in Regina, Saskatchewan, I hold a valid Canadian work permit and am actively seeking a CRA role in Canada where I can leverage my skills to support high-quality, compliant, and efficient clinical research. I’m open to travel-intensive roles and thrive in collaborative, fast-paced environments that demand precision and regulatory excellence. Let’s connect if you’re looking for a detail-oriented, audit-ready CRA who can drive operational excellence in clinical trials.