Job Responsibilities
Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Team Lead (CTL) and/or line manager.
Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.
Act as a mentor for clinical staff including conducting co-monitoring and training visits.
May provide assistance to the CTL with design of study tools, documents and processes.
Qualifications
Requirements:
Degree in Science, with a major in Pharmacy, Biological / Life Sciences or Nursing from a recognised tertiary institution.
Minimum 2 years relevant experience in the pharmaceutical / CRO industry
Good knowledge of drug development process, clinical trial monitoring procedures, GCP guidelines and medical terminology.
Excellent analytical and problem-solving skills.
Effective organizational, verabla/written communication and interpersonal skills.
Able to travel when required.
for further information, please visit: http://id.jobsdb.com/ID/EN/Search/JobAdSingleDetail?jobsIdList=400003000591818
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