Job Title: Clinical Research Associate - VILNIUS, LITHUANIA
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Vacancy details
Vacancy description:
Job Code:
LITHCRA
Job Title:
Clinical Research Associate - VILNIUS, LITHUANIA
Job Category:
Clinical Research
Contract:
Permanent
Discipline:
CRA
Country:
Lithuania
Location:
Any Location
Min experience:
N/A
Annual salary:
Negotiable
Apply by:
31 Jan 2009
ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialise in the strategic development, management and analysis of programs that support clinical development. ICON currently has over 4000 employees, operating from 52 locations in 30 countries. As part of our continuing expansion programme and organic growth we invite suitably qualified and experienced candidates for the following position in our VILNIUS offices.
DEPARTMENT: Clinical Research
JOB TITLE: Clinical Research Associate (Grade I)
REPORTS TO: Associate Clinical Project Manager/Clinical Project Manager/ Clinical Project Director
LOCATION: VILNIUS, LITHUANIA
1. PURPOSE OF THE JOB:
Identify, select, initiate and close-out appropriate investigational sites for clinical studies. To monitor those sites in order to ensure that studies are carried out according to the study protocol and in accordance with ICON SOPs/WPs, applicable regulations and the principles of ICH -GCP
2. JOB FUNCTIONS/RESPONSIBILITIES:
• Familiarity with ICON Clinical Research SOPs/WPs, GCP and appropriate regulations.
• Familiarity with ICON Systems
• Familiarity with principles of investigator recruitment.
• Co-ordinate 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.
- Coordinate 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 and initiation visits.
- Conduct regular monitoring visits in accordance with the ICON site monitoring SOP/Sponsor site monitoring SOP/WP, 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 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.
- Ensure correct archiving of files on completion of a study.
- Co-operate with sponsor and/or ICON QA personnel in the conduct of QA audits.
- Participate in feasibility studies for new proposals, as required
- Maintain patient and sponsor confidentiality.
• To be cost effective
• To participate in mentoring of new staff up to Clinical Research Associate level as appropriate.
• Assist with marketing the company if and when appropriate.
3. QUALIFICATIONS/EXPERIENCE REQUIRED:
• Medical/science background and relevant experience.
• Ability and willingness to travel at least 50% of the time (international and domestic: fly and drive).
• Ability to review and evaluate clinical data.
• Computer literacy desirable.
• Foreign language skills desirable.
• Current full driving licence essential.
• Good oral and written communication skills.
ICON is an equal opportunities employer.
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