Senior CRA

Job Description

• Recognize, exemplify and adhere to ICON's values which center around our commitment to People Clients and Performance.
• As a member of staff, the employee I expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
• Ability and willingness to travel at least 60% of the time (international and domestic: fly and drive)
• 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:

o   Identify investigators.

o   Help, when requested, in preparation of regulatory submissions.

o   Design patient information sheets and consent forms.

o   Coordinate documents translation, verification and back translations where required.

o   Ensure timely submission of protocol/consent documents/safety reports for ethics/IRB approval according to local requirements

o   Pre Study/placement and initiation visits

o   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.

o   Motivate investigators in order to achieve recruitment targets.

o   Complete accurate study status reports.

o   Ensure the correct storage of drugs and the diligent account of all drugs in accordance with SOPs.

o   Keep the project manager or designees regularly informed.

o   Process case record forms to the required quality standards and timelines. Deal with sponsor generated queries in a timely manner.

o   Ensure the satisfactory close-out of investigator sites.

o   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.

o   Ensure correct archiving of files on completion of a study.

o   Maintain patient and sponsor confidentiality.

o   Assume additional responsibilities as directed by Project Manager (PM)

o   Responsible for the conduct/management of any aspect(s) of a project, when requested and authorized by a Project Manager.

o   Act in a Lead role on a study, assuming additional responsibilities as detailed/documented by the Project Manager, if appropriate.

o   Coordinate and/or participate in feasibility studies for new proposals, as required.

o   Investigational Products (IPs) stored and managed by the site: •

§  Ensure storage conditions and acceptable supplies are provided

§  Ensure IPs are 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

Skills, Experience, and Education

• Experience should include monitoring skills. Experience should be a minimum of 3 years of active independent field monitoring and site management experience.
• Ability to review and evaluate clinical data arising from aptitude and have the required level of experience in clinical research.
• Must be able to travel 65%-75% per month
• Bachelors degree, or local equivalent, in medicine, science, or related discipline.