AMINA KHAN

• II STUDY| LEAD CRC ENDOCRINOLOGY TRIAL Led a double-blind, placebo-controlled study on Magnesium's role, overseeing participant recruitment, screening, and data collection
• Successfully managed 200 participants, reducing data entry errors by 60%.
• II STUDY| PRIMARY CRC CARDIOLOGY & PSYCHOLOGY TRIAL A prospective mental health screening study in coronary artery disease patients, developing and implementing data collection strategies while ensuring regulatory compliance
• Surpassed participant targets and achieved a 99% accuracy rate in data collection.
• II STUDY| LEAD CRC CARDIOLOGY TRIAL Led a prospective study on SHARPVeda, coordinating crossfunctional collaboration in protocol development, CRF creation, and data management
• Achieved a 98% protocol adherence rate, demonstrating a significant 40% reduction in calcification progression compared to the control arm.
• PHASE III | PRIMARY CRC GASTROENTEROLOGY TRIALCoordinated essential documentation tasks for a Phase III trial on Linaclotide, including EDC, ECRF, and Source Note documentation
• Achieved a 50% increase in participant retention and ensured 100% adherence to the study protocol and Good Clinical Practice standards.
• PHASE III | PRIMARY CRCONCOLOGY TRIALManaged data collection, reporting, and continuous monitoring for adverse events in a Phase 3 study on Amivantamab and Lazertinib with platinum-based chemotherapy for EGFR-mutated NSCLC postOsimertinib failure
• Also, supervised the proper handling and storage of investigational drugs at the trial site.

• PHASE III| Bariatic Randomized, double blind, Placebo controlled, 4-arm study to Investigate the Efficacy and Safety of LY3437943 Once Weekly in Participants without Type 2 Diabetes who have Obesity
• Lab Process, TMF, EDC, patient coordination, AE update and successfully completed 80% of patient pool within a month

As a Clinical Trial Coordinator, I manage the planning and execution of clinical trials, ensuring compliance with regulatory standards. My responsibilities include medical writing, regulatory submissions, overseeing data collection and management, and coordinating with clinical research coordinator and PI to facilitate trial progress. I maintain communication with cross-functional teams and ensure adherence to Good Clinical Practice (GCP). With a strong background in clinical research and a commitment to advancing medical knowledge, I aim to enhance patient care through effective trial management.

Gold study

Glioblastoma

Colon cancer

Breast cancer

CTRI submission along with data management:

• Skilled in the complete process of preparing, reviewing, and submitting clinical trial data to CTRI.
• Proficient in managing regulatory requirements, ensuring adherence to ethical guidelines, and tracking submissions to meet registration timelines.
• Proficient in data collection, validation, and management within clinical trial databases, ensuring data integrity and compliance with industry standards.
• Hands-on experience with data cleaning, querying, and database management software, including tools like EDC (Electronic Data Capture) systems.