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Clinical Trial Coordinator II

Pharmaceutical Product Development (PPD)

KR-Seoul-FSP Seoul KR Hangangdaero

Provides administrative and technical support to Project Team. Coordinates responsibilities of project administration as applicable to client contracts under direction of assigned Clinical Manager. Responsibilities may include, but are not limited to: Performing PPD Investigator file reviews, preparing project meeting minutes, performing mass mailings and communications to sites, processing regulatory documents, CTMS data entry, updating and maintaining vendor trackers and maintaining data repositories.Coordinates, oversees and completes administrative functions on assigned trials including, but not limited to, reviewing and transmitting regulatory documents, processing documents sent to file, QC and reconciling project reports, performing mass mailings and faxes, managing and distributing paper study supplies to sites.Performs PPD Investigator file reviews and logs findings in CTMS.Practices data stewardship by updating and maintaining assigned data points within CTMS in a timely fashion.Coordinates team conference calls, documents, completes and distributes meeting minutes from internal/client meetings.Maintains a working knowledge of GCPs, PPD Global SOPs, applicable client SOPs and protocol-related specifics through professional career development to ensure investigative site regulatory compliance.Serves as a resource to the project team.Provides administrative and technical support to Project Team. Coordinates responsibilities of project administration as applicable to client contracts under direction of assigned Clinical Manager. Responsibilities may include, but are not limited to: Performing PPD Investigator file reviews, preparing project meeting minutes, performing mass mailings and communications to sites, processing regulatory documents, CTMS data entry, updating and maintaining vendor trackers and maintaining data repositories.Coordinates, oversees and completes administrative functions on assigned trials including, but not limited to, reviewing and transmitting regulatory documents, processing documents sent to file, QC and reconciling project reports, performing mass mailings and faxes, managing and distributing paper study supplies to sites.Performs PPD Investigator file reviews and logs findings in CTMS.Practices data stewardship by updating and maintaining assigned data points within CTMS in a timely fashion.Coordinates team conference calls, documents, completes and distributes meeting minutes from internal/client meetings.Maintains a working knowledge of GCPs, PPD Global SOPs, applicable client SOPs and protocol-related specifics through professional career development to ensure investigative site regulatory compliance.Serves as a resource to the project team.Education and Experience: High School/Secondary school diploma or equivalent and relevant formal education required. Bachelor’sDegree preferred or good general education, combined with evidenced administrative competence and relevant IT skills. In all cases, the combination of education, training and experience provides the individual with the required knowledge, skills and abilities to do the job.Prior clinical research administrative experience, (comparable to at least 2 years). In some cases, previous experience in a clinical environment where experience is gained in clinical trials, data management, medical terminology, medical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered. Knowledge, Skills and Abilities: Self motivated, positive attitude with effective oral and written communication and interpersonal skillsAbility to work in a team or independently as requiredGood organizational skills and strong attention to detail, with demonstrated ability to handle multiple tasks efficiently and effectivelyDemonstrated ability to effectively analyze and update project-specific data/systems to ensure accuracy and efficiencyDemonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelinesStrong customer FocusDemonstrated ability to attain and maintain a good working knowledge of applicable ICH GCP, FDA guidelines, local regulations, PPD and client SOPs and WPDsGood English language and grammar skillsGood computer skills, proficient in MS office and ability to obtain and retain knowledge, so as to maintain and update computer-based clinical trial database systemsAbility to successfully complete PPD clinical training programPharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.Education and Experience: High School/Secondary school diploma or equivalent and relevant formal education required. Bachelor’sDegree preferred or good general education, combined with evidenced administrative competence and relevant IT skills. In all cases, the combination of education, training and experience provides the individual with the required knowledge, skills and abilities to do the job.Prior clinical research administrative experience, (comparable to at least 2 years). In some cases, previous experience in a clinical environment where experience is gained in clinical trials, data management, medical terminology, medical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered. Knowledge, Skills and Abilities: Self motivated, positive attitude with effective oral and written communication and interpersonal skillsAbility to work in a team or independently as requiredGood organizational skills and strong attention to detail, with demonstrated ability to handle multiple tasks efficiently and effectivelyDemonstrated ability to effectively analyze and update project-specific data/systems to ensure accuracy and efficiencyDemonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelinesStrong customer FocusDemonstrated ability to attain and maintain a good working knowledge of applicable ICH GCP, FDA guidelines, local regulations, PPD and client SOPs and WPDsGood English language and grammar skillsGood computer skills, proficient in MS office and ability to obtain and retain knowledge, so as to maintain and update computer-based clinical trial database systemsAbility to successfully complete PPD clinical training programPharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.

Job posted: 2020-05-28

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