Clinical Research Associate II
Location – Home-based, anywhere in the US.
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. The successful candidate will identify, select, initiate and close-out appropriate investigational sites for clinical studies. Monitor those sites in order to ensure that studies are carried out according to the study protocol and in accordance with ICON SOP’s/WP’s applicable regulations and the principles of ICH-GCP. Provide a benchmark of monitoring competence to inexperienced/less experienced colleagues.
Overview of the Role
Travel (approximately 60%) domestic and/or international.
Expert knowledge of ICON’s SOP’s/WP’s, ICH, GCP and appropriate regulations.
Familiarity with ICON systems.
Maintain timelines. Ensure accuracy and completeness of data entered into ICON systems.
Recruitment of investigators.
Independent and proactive coordination of all the necessary activities required to set up and monitor a study, including but not limited to the following:
Help when requested, in preparation of regulatory submissions.
Ensure timely submission of protocol/consent documents for ethics/IRB approval.
Pre study/placement of protocol/consent documents for ethics/IRB approval.
Pre study/placement and initiation visits.
Conduct regular monitoring visits in accordance with the ICON site monitoring SOP/sponsor site
Monitoring SOP, 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 SOP’s.
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.
Participate, if requested, in the preparation of and review of study documentation, e.g. draft protocols, draft CRF’s, monitoring guidelines and elements of final report.
Participate in feasibility studies for new proposals as required.
Ensure correct archiving of files on completion of a study.
Maintain patient and sponsor confidentiality.
Assume additional responsibilities as directed by the Department Head.
Investigational Products (IP’s) stored and managed by the site
Ensure storage conditions and acceptable supplies are provided.
Ensure IP’s are supplied only to patients.
Ensure IP receipt, use and return are controlled and documented.
Ensure disposition of unused IP comply with regulatory requirement and are in accordance with the sponsor.
Responsible for cost effectiveness.
Participate in training and mentoring new staff up to Clinical Research Associate level as appropriate.
Assist with marketing the company if and when appropriate.
Other duties as assigned.
Role Requirements / Skills / Experience Required
Bachelor’s degree or equivalent in medicine, science or related discipline.
Experience should include monitoring skills. Experience should be a minimum of 2 years of active independent field monitoring with intensive PK Phase I studies and site management experience.
Ability to review and evaluate clinical data.
Computer literacy desirable
Good oral and written communication skills.
Due to the nature of this position, it may be required for the employee to travel. Therefore, dependent on the employee’s location, the employee may be required to possess a valid Driver’s license.
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.
In addition you will have the opportunity to develop within your role and take on further responsibilities or develop your skill set within other related departments of ICON.
Following your application if you are successful you will be invited to an initial telephone interview with one of our dedicated recruiters who will be able to provide you with more details of this opportunity.
Clinical Research Associate
US-Any US location
Clinical - Operations
30/Jan/14, 5:16:11 PM