Clinical Research Coordinator-Ji'Nan

Novotech

Jinan, Shandong
Permanent
Full-time

27 days ago

Job Description:

Follow the assignment and direction by director of department.

Site Start-up.

Documents Submission and Kick off meeting.

Site start-up.

Project Execution and Management.

ICF Management.

Assist in the screening, enrollment, and follow-up visit of subjects.

Subject noncompliance behavior management.

Data collection and source data management.

Trail drug management.

To monitor with CRA, QA, and QC.

Data entry and management.

Data collection and source document management.

Data Entry.

AE, SAE, PD, and PRF record and report.

Site Close-out.

Administering the clinical trial properly and assisting to solve problem.

Support other colleagues to implement ongoing projects or affairs. Participate voluntarily

in all kinds of works and various activities of department.

Participate in audit by customer and regulatory agencies.

Responsible for project quality, progress, resource assignment and management.

Perform the tasks assigned by line manager.

Qualifications:Education and Experience:

College above, graduated in Medicine, Nursing, and Pharmacology related departments graduation.

1 year and above working experiences are preferred.

1 year and above working experience as CRC or in clinical research industry is preferred.

Familiar with office and Project software.

About Us: Novotech has offices in 11 geographies across the region, and site partnerships with key medical institutions.Novotech provides clinical development services across all clinical trial phases and therapeutic areas including: feasibility assessments; ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, report write-up to ICH requirements, project and vendor management. Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies.About the Team: Novotech is a leading Asia-Pacific biotech specialist CRO and consists of two operating brands, Novotech and PPC. Novotech is a clinical CRO with labs, phase I facilities, and drug development consulting services.It has accumulated experience in over 3,700 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biopharmaceutical clients conducting clinical trials in Asia and globally.As of September 30, 2021, Novotech had over 2,750 FTEs across 11 geographies in Asia-Pacific, the United States and the UK.

Novotech

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