Clinical research associate gathers and organizes information obtained during studies conducted in the field like biotechnology and pharmaceuticals. They coordinate results gained from testing of drugs, products, and medical procedures. In addition to that, they need to ensure these products are safe to allow on the market. These professionals develop and establish trial sites, train staff, manage investigation product and trial material. The job duties of a clinical research associate include creating trial protocols and presenting them to the committee, identifying and establishing trial sites, closing the sites down on completion of the trial, liaising with the ethic committee regarding safety and rights, ordering, tracking and managing IP material, maintaining confidentiality, updating information and verifying IP with the protocol, coordinating project meetings and implementing an action plan for sites. A clinical research associate needs to have a bachelor’s degree in biological science with more than 2 years of experience in a similar field. He should know about the pharmaceutical industry, terminology, practices, FDA regulations, and practical implementations.
Clinical Research Associate Resume
Name: Abby Smith
Address: 1058, Meadow Lark Road, Decatur, AL 34703
Phone: 456 – 406-724
Email: [email protected]
Current Job: Clinical Research Associate, Atrium Medical Corporation, Decatur, AL
Objective:
Creative and diligent clinical research associate with extensive experience from concept to developments. Possess in-depth knowledge about ICH guidelines, SAE reporting, and GCP auditing. Integral team player with excellent interpersonal and communication skills. Proven communicator with comprehension skills. Strives to be friendly and facilitate a comfortable working environment.
Skills
- Exquisite clinical research monitoring experience
- In-depth knowledge about guidelines and systems for clinical trial management
- Great understanding of therapeutic indications in the clinical trial
- Able to grasp exact information from medical reports
- Superior organization retention and time management skills
- Knowledge about FDA regulatory requirements like GCP and FCH
Work Experience
Clinical Research Associate, Atrium Medical Corporation, Decatur, AL ( 2016 – present )
Duties and Responsibilities:
- Assist in designing clinical research projects
- Managed progress of protocol and studies manuals and budget
- Arranged and finalized site payment
- Conducted site visit including initiation, monitoring, and close visit
- Facilitated to hire, train and supervise regional monitors
Clinical Research Associate, Green Care International, London (2014 – 2016 )
Duties and Responsibilities:
- Monitoring subject and following up from clinical trial
- Coordinating lab samples and compiling data
- Coordinating with medical professionals to determine the changes in subjects
- Managing project and oversaw team of 4 research associates
- Maintaining good clinical practices in compliance with ICH guideline
Clinical Research Associate, Trioex Inc, London (2012 – 2014 )
Duties and Responsibilities:
- Screened and recruited staff based on eligibility criteria
- Scheduled team study meetings and reported finding to lead CRA
- Conducted pre-site visit and performed site evaluation
- Maintained patient record and study information using computer hardware and software to enter and process data
Education:
Masters in Science – Dale Bleaker University, London, UK
Bachelor Degree in Science – Arizona State University
High School: Regent High School, Arizona
Reference:
Martin Luther, Clinical Research Associate, Green Care International, London
Personal Information:
- Civil Status: Married
- Date of Birth: 19/10/1987
- Hobbies: reading and gardening
