Clinical Research Associate Ii

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.
- 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: Identify investigators. 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 authorised 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 required. lnvestigational 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.
- *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.

Education level:
Bachelor’s Degree in Life Sciences or equivalent/related field

Experience level:
Minimum 5 years experience in a similar role. Experience in conducting clinical studies from start up to monitoring and close-out activities within the APAC Region (preferred).

Oncology experience will be special consideration.

Experience in training/mentoring of other CRAs.

Other requirements:
For e.g. Good organizational skills and the ability to manage multiple tasks. An excellent level and proven experience of high standards of attention to detail. Good written and verbal communication skills. Proficient in English and language required for country assignments. Ability to be customer focused is essential. Logical and critical thinking skills.