Clinical Trial Coordinator

**Job Description**:
Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

This role is responsible for comprehensive trial and site administration. Under the oversight of the Senior COM or COMs (Clinical Operations Manager),, the person prepares, collates, distributes and archives clinical documents.
The role is critical to meet planned Site Ready dates and, including assisting with the preparation of submission packages to IRB/ERC and Health Authorities. The role will collaborate at local level closely with COM, CRM and CRA.

Responsibilities include, but are not limited to:

- Trial and site administration:
oTrack (e.g. essential documents) and report (e.g. Safety Reports)

oEnsure collation and distribution of study tools and documentsoUpdate clinical trial databases (CTMS) and trackersoClinical supply & non-clinical supply management, in collaboration with other country roles

oManage Labeling requirements and coordinate/sign translation change request, in collaboration with other country roles (if applicable)
- Document management:
oPrepare documents and correspondenceoCollate, distribute/ship, and archive clinical documents, e.g. eTMF

oAssist with eTMF reconciliationoExecute eTMF

Quality Control Plan

oUpdate manuals/documents (e.g., patient diaries, instructions)

oDocument proper destruction of clinical supplies

.oPrepare Investigator trial file bindersoObtain translations of documents
- Regulatory & Site Start-Up responsibilities:
Collaborate with other country roles to:
oIn a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions

oObtain, track and update study insurance certificates

oSupport preparation of submission package for IRB/ERC and support regulatory agencies submissions

.oPublish study results for GCTO and RA where required per local legislation
- Budgeting, Agreement and Payments:
Collaborate with finance/budgeting representatives for:
oDevelop, control, update and close-out country and site budgets (including Split site budget)

oDevelop, negotiate, approve and maintain contracts (e.g. CTRAs)

oTrack and report contract negotiations

oUpdate and maintain contract templates (in cooperation with Legal Department)

oCalculate and execute payments (to investigators, vendors, grants)

oEnsure adherence to financial and compliance procedures

oMonitor and track adherence and disclosures

oMaintain tracking tools

oObtain and process FCPA documentation in a timely manner

MeetingPlanning:
oOrganize meetings (create & track study memos/letters/protocols)

oSupport local investigator meetings (invitations, prepare materials, select venue,support vendor where applicable)

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
No relocation

**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Number of Openings**:
1
**Requisition ID**:R200238