my rice bowl

once and for all, i tot i'll put up my job description (found it on the company's webpage, shouldnt be a prob publishing it since its on the www anyway...it doesnt seem like an updated one but heck...and for obvious reason, i've to take out my company's name) so to clear the air what i do, what monitoring means and the specs to be a CRA (clinical research associate). it wont explain monitoring per se but the gist of it is there. for the benefit of doubt:

• investigational sites = hospitals
• clinical studies = clinical trials
• ICH-GCP = International Conference on Harmonisation-Good Clinical Practice (both are of different links)
• Investigators = doctors/ specialists/ registrars/ etc
• Sponsors = drug companies (for someone in my business....tis is a giveaway what company i work for)

1.PURPOSE OF THE JOB:

Identify, select, initiate and closeout 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 company SOPs/WPs, applicable regulations and the principles of ICH-GCP

2.JOB FUNCTIONS/RESPONSIBILITIES:

• Familiarity with company SOPs/WPs, ICH-GCP and appropriate regulations.
• Familiarity with company 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 company site monitoring SOP/Sponsor site monitoring SOP/WP, as appropriate

-Complete monitoring visit reports and follow-up letters in a timely manner.

-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 company 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 license essential.
• Good oral and written communication skills.