Ajey Nachnani, Toronto, Ontario, Canada
CLINICAL RESEARCH ASSOCIATE
Areas of Expertise – Clinical Trial MonitoringEthics in clinical research ICH-GCP Guidelines Regulatory requirements: HC, DIV.5, FDA, and Drug control etc. HIPPA and PIPDEA US (FDA), Health Canada (TPD) Regulatory Compliance, Audit and Self inspection ECRF/Data management – Medi-data Rave, Inform, Redcap, and Omni. Monitoring – Site Qualification, Site initiation, Interim Monitoring, Study Close-out Visits Drug Safety/Pharmacovigilance Site Management Regulatory Submissions: CTA / CTA-A / CTA-N CTD / eCTD Study-Specific Protocols Subject Rights & Wellbeing, Recruitment / Screening Pharmaceutical Studies Therapeutic Experience: Neurological Disorders – Dementia, Parkinsonism, Stroke. Dermatology- Skin irritation (Patch studies) Eczema. Immunology – Allergy studies Cardiology studies and gastrointestinal studies.
Skilled Clinical Research Associate with a track record of success in progressively responsible positions in clinical environments. Post Graduate diploma in Clinical Research and Regulatory Affairs in addition to the strong Medical background as International Medical Graduate. Experienced in monitoring – multiple site locations, clinical site evaluation, initiation, maintenance and close-out visits in accordance with GCP, company SOPs and other applicable regulatory standard, while ensuring integrity of study data and following study timelines. Always commended for organization, perseverance, efficiency, and priority management skills.
- excellent communication, both written and verbal, and interpersonal skills
- the ability to build effective relationships with trial centre staff and colleagues
- the ability to motivate others
- strong customer focus
- an excellent grasp of numeracy and a keen eye for detail
- presentation skills
- the ability to multitask and think on your feet
- a flexible and adaptable approach to work
- organisational, IT and administrative skills
- managing clinical trial management systems and electronic data capture
- understanding of the importance of good clinical practice (GCP)
Hourly Rate $70 USD