ICON Clinical Research CRA E/L in Lima, Peru
*Clinical Research Associate- Entry Level
This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. Working within a highly qualified team our Clinical Research Associates (CRA’s) identify, select, initiate and close-out investigational sites for clinical studies in phases II – IV ensuring adherence to applicable regulations and principles of ICH-GCP.
Overview of the Role:
To become familiar with all applicable regulations and ICON SOPs/WPs relevant to the start up, conducting monitoring and closeout of clinical studies. To become proficient and self-sufficient in conducting all procedures in relation to monitoring clinical. Studies, in particular to become experienced in the review and evaluation of clinical data. To participate in all CRA activities when deemed appropriate by the Project Manager
• Recognize, exemplify and adhere to ICON’s values which centers around our commitment to People, Clients and Performance.
• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streaming our processes adding value to our business and meeting client needs.
• Travel (approximately 65-75%) domestic.
• Become familiar with ICON’s SOPs/WPs, ICH GCP guidelines and appropriate regulations.
• Become familiar with ICON systems.
• Maintain timelines. Ensure accuracy and completeness of data entered into ICON systems.
• Become familiar and assist with principles of investigators recruitment.
• Become familiar with the necessary activities required to set up and monitor a study, including the following:
· Identification of investigators.
· Help, when requested, in preparation of regulatory submissions.
· Design of patient information sheets and consent forms.
· Co-ordinate documents translation, verification and back translations where required.
· Ensure timely submission of protocol/consent documents/safety reports for ethics/IRB approval according to local requirements.
· Pre-study/Placement and initiation visits.
· Conduct regular monitoring visits in accordance with the ICON site monitoring
· SOP/Sponsor site monitoring SOP/WPs, as appropriate.
· Maintain all files and documentation pertaining to studies.
· Motivate investigators in order to achieve recruitment targets.
· Complete accurate study status reports.
· Ensure the correct storage of drugs and the diligent account of all drugs in
accordance with SOPs.
· Keep the Project Manager regularly informed.
· Process case record forms to the required quality standards and timelines.
· Deal with sponsor generated queries in a timely manner.
· Ensure the satisfactory close-out of investigator sites.
· Ensure correct archiving of files on completion of a study.
· Co-operate with sponsor and/or ICON QA personnel in the conduct of QA
- Investigational Products (lPs) stored and managed by the site:
Ensure storage conditions and acceptable supplies are provided
Ensure lPs are supplied only to eligible patients
Ensure lP receipt, use supplied and return are controlled and documented
Ensured disposition of unused lP comply with regulatory requirement and are in
accordance with the sponsor.
Participation in data listing reviews, as applicable.
To be cost effective.
Maintain patient and sponsor confidentiality.
Participate if requested, in the preparation of the final report.
Other duties as assigned.
We are seeking associates with a desire to travel 65%-75% both regionally and nationally.
A Bachelor’s degree in the life sciences will ensure your familiarity with regulatory guidelines and clinical terminology.
We invite you to review our clinical opportunities at www.iconplc.com/careers
ICON is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.