Associate Clinical Research Associate

HE OPPORTUNITY

With support of Sr.CRA/CRA and/or CRA-Manager, acts as primary site contact and site manage

rthroughout all phases of a clinical research study, taking responsibility of allocated sites

.
WHAT YOU WILL

DO
• Develops strong site relationships and ensures continuity of site relationships through

allphases of the tri

al.• Performs clinical study site management/monitoring activities in compliance with ICH-G

CP,Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associa

teddocumen

ts.• Gains an in-depth understanding of the study protocol and related procedur

es.• Coordinates & manages various tasks in collaboration with other sponsor roles to achi

eveSite Rea

dy.• Participates & provides inputs on site selection and validation activiti

es.• Performs remote and on-site monitoring & oversight activities using various tools to ensu

re:o Data generated atsite are complete, accurate and unbia

sedo Subjects right, safety and well-being are protec

ted• Conducts site visits including but not limited to validation visits, initiation visits, monitor

ingvisits, close-out visits and records clear, comprehensive and accurate visit & non-vi

sitcontact reports appropriately in a timely mann

er.• Collects, reviews, and monitors required regulatory documentation forstudy start-up, st

udymaintenance and study close-o

ut.• Communicates with Investigators and site staff on issues related to protocol condu

ct,recruitment, retention, protocol deviations, regulatory documentation, s

iteaudits/inspections and overall site performan

ce.• Identifies, assesses and resolves site performance, quality or compliance problems

andescalates per defined CRA Escalation Pathway as appropriate in collaboration with

CRAManager, CRM, TA Head and CRD as need

ed.• Works in partnership with GCTO country operations, finance, regulatory affai

rs,pharmacovigilance, legal and regional operations, HQ functional areas and externally w

ithvendors and IRB/IECs and Regulatory Authorities in support of assigned si

tes• Manages and maintains information and documentation in CTMS, eTMF and various ot

hersystems as appropriate and per timelin

es.• Supports audit/inspection activities as need

ed.• Performs co-monitoring where appropria

te.
Competency Expectati

ons:• Fluent in Local Languages and English (verbal and written) and excel

lentcommunication skills, including the ability to understand technical informat

ion.Developing ability to present technical information with supp

ort.• Good understanding and working knowledge of clinical research, phases of clin

icaltrials, current GCP/ICH & country clinical research law & guideli

nes.• Good understanding of Global, Country/Regional CRA Guidelines and ability to

workwithin these guideli

nes.• Hands on knowledge of Good Documentation Pract

ices• Developing skills in Site Management including management ofsite perform

anceand patient recruit

ment• Developing level of monitoring skill and independent professional judgm

ent.• Good IT skills (Use of MS office, use of some clinical IT applications on compu

ter,tablet and mobile devices) and ability to adapt to new IT applications on var

iousdevi

ces.• Works with high quality and compliance mind

set.• Capable of managing complex issues, solution-oriented appro

ach.• Ability to perform root cause analysis and implement preventative and correc

tiveact

ion.
WHAT YOU MUST

HAVE
• Associate's degree, certificate or equivalent in a scientific / healthcare discipline to

getherwith at least 3 years of relevant experience in the healthcare

fi

eld.Or• Bachelor's degree (or above) in a scientific / healthcare discipline together with at l

east 6months of relevant experience in the healthcare

fi

eld.or• Bachelor's degree (or above) in a non-scientific/healthcare discipline together with at

least2 years of relevant experience in the healthcare