Clinical Research Associate

Mahima Rajbhandari

*******@*****.*** +1-510-***-****

(13) Mahima Rajbhandari LinkedIn

ECFMG certified International Medical Graduate ( IMG) Studying Clinical Lab Scientist at University of California Berkeley Jan 2024- till present Clinical Research Coordinator (CRC) at Pacific cancer care Full time June 2023- Feb 2024

● Monitoring oncology trials.( Investigator experience in oncology trials )

● Navigating a protocol with an interdisciplinary team,

● Weekly presentation of cases, progress report in Research meeting, Pacific Cancer Care Providers ( Doctors, RN, Research Director, etc ) meetings, sponsors meetings.

● Active participation in interactive meetings with various sponsor companies to overcome challenges in patient recruitment.

● Informed consent process

● Managing regulatory binders, housing essential documents including but not limited to 1572, DOA, Training Logs and other Investigator Site File (ISF) documents

● Managing study conduct throughout the study providing subject care as appropriate

● Quality Assurance, Monitoring and Query Resolution

● GDP following ALCOA-C principles

Clinical Research Fastrack

GCP Training and Certification TransCelerate Approved May 2023

● ICH GCP E6 R (2)

● FDA Regulations 21 CFR 11, 50, 54, 56 and the Common Rule 45CFR46

● Data Management

● Informed Consent Process

● Clinical Trial Operations from feasibility through close-out

● GDP following ALCOA-C principles

● Identification and reporting of AEs and SAEs

● Quality Assurance, Monitoring and Query Resolution

● Comprehension and Execution of Clinical Trial Protocol

● Maintaining a regulatory binder, housing essential documents including but not limited to 1572, DOA, Training Logs and other Investigator Site File (ISF) documents Relevant Medical Experience: International Medical Graduate Medical Officer Full time October 2016 – February 2022 Shree Bhawani Hospital and Research Center, Prabhu Hospital and Research Center, Nirvana Wellness Center

● Provided critical care and management to the patients in the Emergency Department

● Assess and triage the patient entering the ER and overseeing emergency recovery

● Conducting follow up visits to monitor the patient’s condition

● Maintain medical records, referring patients to appropriate specialists

● Coordinating with different departments to ensure the patient receives adequate and necessary care

● Develop an effective patient care plan, provide the instruction for discharge and any relevant paperwork.

● Educate patients regarding clinical trials (risk, benefits, purpose, etc). Relevant Skills

● Knowledge of and ability to adhere to good clinical practices (GCP)

● Excellent organizational skills and attention to detail in maintaining accurate, retrievable records

● Ability to interpret and master complex research protocol information

● Precise with the ability to work independently, exercising judgment in establishing priorities

● Ability to prioritize quickly and appropriately

● Strong ability to multitask

● Extensive Medical Knowledge

● Quality Assurance

● Good Interpersonal Skills

● Microsoft Excel, Word

● Ability to work under extreme pressure.

● Perseverant

● Excellent Analytical Skill

● Quick Learner

Fluent Languages

● English

● Nepali

● Hindi

Transferable Research Skills: Develop rapport with patients (participants), good documentation practices, strong communication skills, ability to identify changes in health status (AEs and SAEs), referring and reporting to appropriate entities, resourcefulness. Medical Training and Research Experience

● MBBS College of Medical Sciences 2015

● Dermatophytes Trial

● Collect data per protocol, organize within EDC, interpret data, report finding to the department

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