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Senior CRA

JBlab
서울

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상세 직무 내용

Senior CRA

[JBLab: Cheil Vascular Research Institute] is looking for Clinical research associate (CRA)

JBLab was established to bridge the field of clinical practice with scientific facts of cardiovascular diseases.
The objectives of JBlab are to reveal scientific truth and prove among cardiovascular patients, to detect changes in the cardiovascular system affected by hypertension and diabetes, to stop the progress and help recover, and to study differences in cardiovascular diseases and investigate proper diagnosis and treatment.
We are currently looking for Clinical Research Associate and the primary responsibility of a Clinical Research Associate is to ensure that the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirements.

Job Title:

Clinical Research Associate

Location:

Cheil General Hospital (Seoul, Jung-Gu), Cheil Vascular Research Institute

Duties:

developing and writing trial protocols (outlining the purpose and methodology of a trial);
designing data collection forms, known as case report forms (CRFs);

coordinating with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects;

liaising with doctors/consultants or investigators on conducting the trial;

setting up the trial sites, which includes ensuring each center has the trial materials, including the trial drug often known as the investigational medicinal product. Plus training the site staff to trial-specific industry standards;

monitoring the trial throughout its duration, which involves visiting the trial sites on a regular basis;

verifying that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV);

collecting completed CRFs from hospitals and general practices;

ensuring all unused trial supplies are accounted for;

closing down trial sites on completion of the trial;

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

archiving study documentation and correspondence.

Qualification:
Required:

Bachelor’s in Science/Health Related Field and/or BA

Preferred:

Masters or Nursing Degree; certification as Clinical Research Associate and/or Clinical Research Professional

Yrs. of related experience:

At least 3 years of Clinical Trial experience required in a pharmaceutical, biotech or CRO setting.

At least 1 year of independent clinical monitoring, including qualification, initiation, interim, and close-out. Clinical trials research experience through exposure to protocols in a variety of therapeutic areas and knowledge of FDA/ICH guidelines, GCP’s and regulatory compliance is necessary. Ability to work independently and in a team environment.

Work Schedule:

40hrs per week (There will be 3~6months probation period with 100% of your monthly salary but w/o social insurances)

Benefits:

Social Insurances, Paid Vacation, Professional development opportunities, including tuition reimbursement and career development training

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