Summary
Overview
Work History
Education
Skills
Therapeutic Experience
Certifications
Timeline
Generic

Mariamma Francis

Houston,TX

Summary

To obtain a position with a Contract Research Organization or Pharmaceutical/Biotech Company where I get a chance to utilize my knowledge and my experience. Skilled in evaluating the capability of the site to manage and conduct clinical studies successfully. Strength areas include working with regulatory documents, within GCP-ICH and FDA guidelines, and data management. My goal is to promote healthy clinical research by protecting the rights and welfare of trial patients.

Overview

3
3
years of professional experience

Work History

Clinical Research Associate I + Lead CRC

Biopharma informatics
09.2022 - Current
  • Managing and supervising Clinical Trial Operations from feasibility through close-out
  • Oversee Informed Consent Process
  • Responsible for reviewing GDP sites compliance following ALCOA-C+ principles
  • Ensure adequate data input in various protocol specific EDC and IWRS
  • Identification and reporting of AEs and SAEs
  • Quality Assurance, Monitoring and Query Resolution
  • Comprehension and Execution of Clinical Trial Protocols
  • Maintaining a regulatory binder and housing essential documents
  • Ensure adequate inventory, ordering and documentation of clinical supplies is completed
  • Assist with developing and implementing recruitment plans to ensure long-term recruitment target is met.

Senior Clinical Research Coordinator

Biopharma informatics
04.2021 - 09.2022
  • Work in collaboration with study team to ensure trial preparation
  • Attend and participate in the investigator meetings
  • Serve as main point of contact for all monitoring needs
  • Responsible for drawing blood work and performing EKGs for protocol related timepoints
  • Prepare for monitoring visits to make sure the monitor receives all necessary information during their visits
  • Participate in SQV's, IMV's, SIV's and COV's and accompany the monitor during monitoring activities
  • Responsible for reviewing study protocol with the clinical team and ensuring everyone is aware of their roles and responsibilities
  • Ensure adequate inventory, ordering and documentation of clinical supplies is completed
  • Assist with developing and implementing recruitment plans to ensure long-term recruitment target is met.

Clinical Research Coordinator

LINQ Research
07.2020 - 04.2021
  • Monitoring the study to ensure that it complies with protocols, is ethically conducted, and follows regulatory standards
  • Administering questionnaires and monitoring participants to ensure they adhere to the study's rules
  • Liaising with laboratories regarding research findings
  • Maintaining research records of study activity, including case report forms, drug dispensation records or other regulatory forms as per FDA guidelines
  • Directing the collection, labeling, storage, and transport of all specimens
  • Making sure that all equipment and supplies needed for the study are in-stock and in good working order
  • Set-up, populate and maintain the clinical trial monitoring/management tracking systems
  • Proactively identify study related issues and provide recommendation for resolution
  • Helping with other functions as may be assigned by PI.

Education

Bachelor of Medicine and Bachelor of Surgery (MBBS) -

Pariyaram Medical College
02.2016

Skills

  • Medical Terminology
  • Monitoring
  • Reliable and trustworthy
  • Detail-oriented
  • Interpersonal Skills
  • Multitasking
  • Computer skills: Microsoft Office, Medidata Rave, Inform, Veeva Vault, e-Clinical Works, Flat iron, axiom fusion, Clintrack, IWRS- Endpoint, Calyx, CLIN Trak, Eli Lilly IWRS, Trial Manager
  • Documentation Management
  • Meeting Coordination
  • Report Preparation
  • Data Analysis
  • Trial Management

Therapeutic Experience

  • Rheumatology- Rheumatoid Arthritis, Lupus
  • Respiratory- Asthma, COPD
  • Endocrinology - Diabetic Gastroparesis, Obesity, Diabetes Type 1, Diabetes Type 2
  • Oncology - Colorectal Cancer, Lung Cancer
  • Urology - UTI
  • Inflammation and Immunology- NASH
  • Nephrology - Chronic Kidney Disease, Hyperuricemia
  • Cardiovascular - Angina
  • Infectious Disease - Influenza, Covid-19
  • Treatments- Vaccines

Certifications

  • NIDA - ICH GCP
  • OSHA certified
  • HIPAA
  • IATA training and certified under Mayo Laboratories

Timeline

Clinical Research Associate I + Lead CRC

Biopharma informatics
09.2022 - Current

Senior Clinical Research Coordinator

Biopharma informatics
04.2021 - 09.2022

Clinical Research Coordinator

LINQ Research
07.2020 - 04.2021

Bachelor of Medicine and Bachelor of Surgery (MBBS) -

Pariyaram Medical College

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