Senior / Clinical Research Associate

**Job Title**
Senior Clinical Research Associate (3 years Renewable contract)

**About SCRI**

The Singapore Clinical Research Institute (SCRI) is the national coordinating body (NCB) for

clinical trials with a vision to establish Singapore as a regional thought leader in clinical

research. This is accomplished through the deployment of innovative technologies and

processes, and strategic coordination of ecosystem capabilities and infrastructure to achieve

synergies that will enhance the clinical research ecosystem aimed towards a healthier

community and better patient outcomes.

**The Role**:
You will support the monitoring of investigator sites and trial execution within SCRI and
mentor Clinical Research Associates (CRAs). You will also be responsible for planning and
managing of clinical trial activities which will include:
Support in the management of designated clinical trial activities including preparation of
trial related documentation and study files, organizing Ethics Committee and Regulatory
submissions, progressive and site/study closeout reports with follow through to ensure
successful outcome

Participate in assigned site training activities e.g. investigator meeting and study site
initiation meetings

Facilitate preparation of site and sponsor documents for study conduct and related
activities

Maintain project files including: Ethics Committee approvals and/or acknowledgements;
curriculum vitae of investigators and study personnel; clinical investigators brochure;
protocols; case report forms instructions; consent documents; clinical trial material
shipping orders; start-up meeting attendance documentation; letters of agreement; lab
reference ranges; all investigator and site correspondence; monitoring related reports;
SAE reports and schedules of payment

Facilitate clinical trial management including site drug supply management. Assist in
planning the requirements for clinical trial material, ordering clinical trial (CT) materials,
setting up and monitoring the systems for shipment of CT material to the investigator,
maintaining procedures to account for CT material, checking the expiration of CT
material and requesting extensions if necessary, checking the storage of Investigational
Product (IP).

Be the point of first contact when investigators/site personnel enquire about patient
inclusion/exclusion criteria for ongoing trials

Act as field monitor for assigned sites on a clinical study. Perform monitoring visits in
accordance to study specific monitoring plan including source document verification,
drug accountability checks, etc according to ICH GCP and company SOPs

Prepare site initiation, study monitoring and closeout reports for review and send out
within timelines.

Ensure site activities are in line with milestones (i.e. startup, recruitment, closeout)

Perform SAE processing activities including reconciliation as per ICH GCP and company
SOPs.

Restricted, Non-Sensitive

Assist in the review of Case Report Forms (CRF) and CRF completion guideline. Assist
with data query resolution process (both at Site and with Data Management). Ensure
that queries generated during cleaning are responded to in a timely fashion.

Assist in issue resolution promptly and share best practices with site(s) and company
colleagues

Committee SOPs and company SOPs

Participate and lead in SOP development, process initiatives and assigned training
initiatives/activities

Lead and coach team members on assigned studies and SAE processing

**Requirements: **

A healthcare or scientific discipline (e.g. pharmacy, life sciences, nursing or other related
area) or relevant experience working in medical, QA, regulatory, safety, training or
pharmaceutical company or equivalent

Knowledge of clinical trial monitoring, drug development process, GCP, regulatory
requirements of regional countries, basic knowledge of project management and medical
terminology.

Preferably have passed ACRP CRA examination

Demonstrates strong ability to prioritise, coordinate, organise, communicate and lead

Excellent understanding of clinical development process including ICH GCP
fundamentals

Proven ability to work independently and in teams and deliver commitments on time

Computer literacy

**Research Associate (SCRI)**

**Company Overview**

The Consortium for Clinical Research and Innovation Singapore (CRIS), a wholly owned

subsidiary of MOH Holdings, was established in 2020 with the goal of strengthening

synergies and promulgating strategies for national-level clinical research and translation

programmes under the stewardship of the Singapore Ministry of Health. The former

Singapore Clinical Research Institute Pte Ltd was repurposed to form CRIS which brings

together five entities as business units under a common management and governance

structure. These are the Singapore Clinical Research Institute (SCRI), the National Health

Innovation Centre (NHIC), the Advanced Cell Therapy and Research Institute Singapore

(AC