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Mundipharma Distribution GmbH (Philippine Branch) is in search for a Clinical Research Associate.

Head Office: Unit 1706-1709, Robinsons Equitable Tower, #4 ADB Ave. Cor. Poveda St. Ortigas Pasig City

CLINICAL RESEARCH ASSOCIATE

Responsibilities:

• 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.

• Familiar with developing and writing trial protocols (outlining the purpose and methodology of a trial) and in designing data collection forms, known as case record forms (CRFs);

• Able to effectively present trial protocols during an investigators’ meeting

• Manage regulatory authority applications and approvals that oversee the research and marketing of new and existing drugs;

• Assist investigator meeting including preparation, liaison, presentations, problem resolutions, and follow up.

• Liaise with doctors/consultants (or investigators) on conducting the trial;

• Monitor the trial throughout its duration, which involves visiting the study centres on a regular basis;

• Verify that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV). Deal with CRF queries in a timely manner.

• Assist in the collection of completed CRFs from hospitals and general practices;

• filing and collating trial documentation and reports;

• discussing results with a medical statistician, who usually writes technical trial reports;

• Ensure correct archiving study documentation and correspondence;

Qualifications:

• Licensed Pharmacist

• Experience of clinical trial management would be preferable.

• Knowledge of FDA regulations and ICH/GCP guidelines.

• General knowledge of clinical/ laboratory terminology.

• Good problem solving and analytical skills.

• Computer literacy desirable.

• Strong oral and written communication skills in English.