CRA II

Senior Clinical Research Associate

Position Summary:

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.

Responsibilities:

• 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.

 - 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.

• *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.

Supervision:

Ability to mentor, train and/or supervise other Clinical staff as appropriate.

Experience/Skills Required:

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• US/LATAM/CAN:  Experience should include monitoring skills. Experience should be a minimum of 3 years of active independent field monitoring and site management experience.

• EU/APAC:  Experience should include monitoring skills. Prior relevant active independent field monitoring experience and site management experience.

• Ability to review and evaluate clinical data arising from aptitude and have the required level of experience in clinical research.

• Computer literacy required. 

• Foreign language skills 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 Drivers license.

Bachelors degree, or local equivalent, in medicine, science or related discipline.