Clinical Trial Assistant

• Mar 2022 - Present

● Assisted in managing a cardiac Medical Device Study involving 70 sites. ● Supported CRAs and Project Managers for multi-centered trials by monitoring project timelines and site compliance. ● Worked closely with various teams for data cleaning, query resolution and data reconciliation tasks. ● Prepared, distributed, and archived clinical documentation of the trial, maintained various Study trackers and Trial Master File. ● Assist with preparation, shipment, and submission of regulatory documents to the responsible authorities and Institutional Ethics Committees. ● Retrieved a disrupted study on track by tracing down all the files and documents across all the sites. ● Prepared minutes of meeting. Show less

Clinical Research Coordinator

• Sep 2020 - Mar 2022

•Accountability for all operational facets of clinical trials, meticulously ensuring adherence to ICH-GCP standards, protocols, and pertinent SOPs and guidelines. •Diligently documented and transcribed diverse sources of clinical data into the Electronic Data Capture (EDC) System, encompassing both Electronic Case Report Forms (eCRFs) and traditional Paper CRFs, while adeptly resolving inquiries. •Collaborated in supporting the Principal Investigator, Sub-Investigator, and site personnel in various trial-related endeavors, from guiding the Informed Consent Process during Screening and Randomization to overseeing activities through the 'End of Study' visits for subjects. •Orchestrated seamless communication channels among Physicians, the Sponsor team, Clinical Research Associates (CRAs), Central and Local Labs, Interactive Web Response Systems (IWRS), and ancillary services. •Held the mantle of responsibility for Investigational Product (IP) Accountability, encompassing distribution, maintenance, and logistical oversight at the site throughout the duration of the study. •Engaged in active correspondence with the Ethics Committee, managing submissions, notifications, queries, and approvals tied to protocols. •Maintained the Site Master File, Source Documentation, and diligently completed Feasibility Questionnaires. •Provided invaluable assistance to monitors throughout Site Selection, Initiation, and Closeout Visits, as well as during multiple Monitoring visits, spanning both remote and on-site operations. •Proficiently managed the reconciliation of Adverse Events (AEs) and Serious Adverse Events (SAEs), ensuring that safety reporting unfolded within dedicated timelines. •Conducted comprehensive training sessions for newly onboarded Clinical Research Coordinators (CRCs), enriching their understanding of clinical trial intricacies. •Demonstrated an additional skill set by acquiring proficiency in performing Electroencephalograms (EEGs) and Electrocardiograms (ECGs). Show less

Dietitian

• Jan 2019 - Mar 2022

Conducting individual or group assessments to evaluate clients' health status and dietary needs, and developing customized nutrition plans and strategies to meet those needs. Providing nutrition education and counseling to clients to help them achieve their health goals, such as weight loss, managing chronic conditions, or improving athletic performance. Collaborating with other health professionals such as doctors, nurses, and physical therapists to provide comprehensive care to clients. Providing guidance and support to clients with special dietary needs or restrictions, such as those with food allergies, intolerances, or cultural preferences. Conducting research and staying up-to-date on the latest nutrition trends and research to ensure the most effective and evidence-based advice is provided to clients. Building a network of potential clients and marketing services to attract and retain clients. Managing business operations such as finances, scheduling, and client communications. Show less

Clinical Research Coordinator

• Jun 2019 - Aug 2019

Dietitics Internship

• Nov 2017 - Dec 2017