Marie Jian

Reliable Clinical Research Associate capable of maintaining an objective stance and providing accurate information on a daily basis. Long track record of working well with healthcare professionals and clinical sites, correctly interpreting specifications and understanding the compliance needs of each project. Understands the tremendous amount of responsibility involved with being a Clinical Research Associate.

Core Qualifications

• Medical Degree and medical practice experience

• CCRP Certified

• Pharmaceuticals Expert
• Deliver high quality medical information
• Evaluate clinical study protocols

• Corporate Communications

• Digital Record Keeping

Experience

Consultant in Medical Affairs/Medical Science Liaison

2019 – 2022 

Private Company – Canada

• Develop enduring value-based trusted partnerships, through scientific engagement and exchange, with healthcare professionals and institutions
• To generate actionable and valuable insights and propose solutions.
• Communicate in an accurate, fair and balanced manner, the benefits, risks, appropriate use and clinical value of the products and solutions.
• A good understanding of clinical development and clinical research. Critically evaluate clinical study protocols, reports and publications
• Engagement with key opinion leaders, key institutions, clinical investigators
• Engage in scientific exchange to communicate medical evidence and gather medical insights.
• Provide scientific expertise, and engage in ongoing scientific exchange and balanced discussion of science.
• Provides high quality scientific and medical Information to both internal and external stakeholder’s on request and in a timely manner.
• Maintains an up to date and high level knowledge of the therapy area, including company products, new and emerging research areas, therapeutic issues and trends
• Product launch preparation and execution.

Clinical Research Associate

2017 – 2019
Covance – USA

• Monitored Oncology Trials
• Conducting site monitoring visits (MV) at assigned clinical sites for Oncology studies
• Review the performance of the trial at designated sites, ensuring the rights and well-being of human subjects 
• Evaluate the quality and integrity of the reported data, site efficacy, drug accountability
• Performing data verification of source documents, Ensuring completion, collection of SAEs 
• Monitor completeness and quality of Regulatory Documentation
• Maintenance of clinical documents, protocol, amendments, summary of changes, ICFs. CSRs. SAE narratives and patient summaries
• In-patient and Out-patient care 
• Site selection and initiation visits,
• Organize and manage trial master file (TMF),
  Generating correspondence and reports without secretarial help,
• Verify that documentation of collected data is complete and accurate,
• Electronic Data Capture (EDC) system; Review Data/Listing/Auto and Manual Queries,
  Report adverse events as required by regulatory and sponsor SOP guidelines,
• Investigator site progress monitoring, Database Lock.
• Worked both as a Site Monitor and an In-house CRA
• Investigator site progress monitoring for cardiovascular imaging studies Phase I and II
• Review Data/Listing/Manual Queries,
• Monitor study site’s compliance with GCP guidelines,
• Perform periodic visits to monitor compliance with recruitment, informed consent and study procedure guidelines, Work on TMF reconciliation,
• Resolves site regulatory issues, questions and concerns discovered during visits
• Reviews site-level data in clinical systems, evaluates data quality issues, and implements follow-up response
• Act as an in-house CRA: Provide support to the clinical operations team to assist with the execution, management and maintenance of clinical studies
• Coordinate preparation, collection, review and tracking of key clinical study documents, essential documents as needed
• Support set-up and maintenance of TMF
• Preparation of FDA audits.

Family Medicine Physician

2010 – 2015
Kangneier Children Hospital – China

• Diseases Diagnosis and treatment

Clinical Research Associate

2008 – 2009
INC Research – Canada

• Full independent home-based monitor for a large Phase III Vaccine study (three sites, visited once a week),

Clinical Research Associate

2007 – 2007
Bristol-Myers-Squibb, USA

• Monitored Clinical Trials of Cardiovascular Disease and Rare Disease

Research Associate

1999 – 2002
National Research Council – Canada

• Research Subject: Role of certain knock-out genes in neuronal death following stroke
• In-patient and Out-patient care 

Resident Physician

October 1996 – December 1998
Beijing SOS International Clinic – China

• Diseases Diagnosis and treatment

Research Assistant

September 1993 – September 1995
University of Ottawa – Canada

• Conduct Neuroscience Research in the Department of Pharmacology

Education

1995 Master’s Degree, Pharmacology
University of Ottawa – Ottawa, Canada

2022 Certification of Advanced Medical Monitor, Clinical Research

Certified Clinical Research Professional Society -- USA