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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.
*LI-PG1
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