Senior Clinical Research Associate
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, ICON SOPs/WPs, applicable regulations and the principles of ICH-GCP. Depending upon experience, become involved, when required, in other areas of study management and staff training and contribute to the review of ICON systems and procedures as appropriate. 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 Clinical Research SOPs/WPs, ICH, GCP and appropriate regulations.
Expert knowledgeable of ICON systems.
Maintain timelines. Ensure accuracy and completeness of data entered into ICON systems.
Recruitment of investigators.
Independent and proactive co-ordination of all the necessary activities required to set up and monitor a study, including the following:
Help, when requested, in preparation of regulatory submissions.
Design 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, 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 or designees 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 CRFs, monitoring guidelines and elements of final report.
Ensure correct archiving of files on completion of a study.
Maintain patient and sponsor confidentiality.
Assume additional responsibilities as directed by Project Manager (PM).
Responsible for the conduct/management of any aspect(s) of a project, when requested and authorized by a Project Manager.
Act in a Lead role on a study, assuming additional responsibilities as detailed/documented by the Project Manager, if appropriate.
Co-ordinate and/or participate in feasibility studies for new proposals, as require
Investigational Products (IPs) stored and managed by the site:
Ensure storage conditions and acceptable supplies are provided
Ensure IPs is supplied only to eligible 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.
Be cost effective.
Participate in training and mentoring new staff up to Clinical Research Associate level as appropriate.
Participate in data listing reviews, as applicable.
Assist with marketing the company if and when appropriate.
Other duties as assigned.
Ability to mentor, train and/or supervise other Clinical staff as appropriate.
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 4 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
24/Sep/13, 8:25:32 PM
ICON Clinical Research - 6 months ago
Contract research organization (CRO) ICON is not iconic yet, but it would like to be. By the time a new drug hits the market, it has passed...