Ref #: 30654

Employment type: Permanent - Full-Time

Location: China-Shanghai

Posted: 14-Jul-2021

Description

SECTION 1: POSITION SUMMARY

Clinical Study Administration services include processing, tracking, and filing of study documents, and
management of the Trial Master File within the clinical projects. Additionally, services will
include administrative support of clinical study staff, as required. Supports project managers within the
assigned clinical studies.



SECTION 2: JOB FUNCTIONS/RESPONSIBILITIES

( List statements in bullet format )


? Services rendered will adhere to applicable Johnson & Johnson SOPs, WIs, policies, local
regulatory requirements, etc.
? Maintain and track relevant activities in CTMS in partnership with Study Teams.

? Creates and distributes regulatory binders.

? Tracks, in a timeline manner, essential study documents and ensures completeness of the Trial

? Master File for assigned clinical studies according to appropriate regulations, departmental
guidelines, and work instructions.
? Distributes safety documentation to other functional groups in support of safety committee
meetings as requested (supporting role).
? Creates and generates system reports.

? Supports creation, ordering and distribution of study supplies to sites (e.g. print protocols, burn
DVDs).

? Assists with Device tracking and ordering, if required and if applicable.

? Assists with logistics for Investigator meetings/expert panel meetings. Metrics/KPls governing
these services are outlined in the Quality Oversight Plan (QOP) document.

Metrics/KPls: Metrics/KPls governing these services are outlined in the Quality Oversight Plan (QOP)

document.



SECTION 3: EXPERIENCE, SKILLS, KNOWLEDGE REQUIREMENTS

( List requirements in bullet format )

? Requires previous administrative support experience or equivalent for at least 1 year.

? Previous clinical research experience a plus.

? Clinical/medical background a plus.
? Requires experience and knowledge working with computer systems (Microsoft office - Excel, Word
and Power Point).



SECTION 4: EDUCATION REQUIREMENTS

( List requirements in bullet format )


? Bachelor's Degree.