Clinical Research Associate

Job Description Clinical Research Associate (CRA)

• Based in Malaysia, named one of the

Best Companies to Work for in 2019

by HR Asia

‘Sponsor of the Year’

in 2019, 2020, 2022 and 2024 from Clinical Research Malaysia for the highest number of studies and total study value recorded in the country!

125 years The role is accountable for performance and compliance for assigned protocols and sites in a country.

Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH / GCP and country regulations, our company’s policies and procedures, quality standards and adverse event reporting requirements internally and externally.

Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. Actively develops and expands the territory for clinical research, finding and developing new sites. Participates in internal meetings and workstreams as SME for monitoring processes and systems.

Responsibilities include, but are not limited to :

management / monitoring

activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.

appropriate / required.

Extent of Travel :

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. Current Employees apply

HERE Current Contingent Workers apply

HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status : Regular

Relocation : VISA Sponsorship : Travel Requirements : Flexible Work Arrangements : Hybrid

Shift : Valid Driving License : Hazardous Material(s) : Required Skills : Accountability, Accountability, Adaptability, Adverse Event Reporting System, Biopharmaceutical Industry, Biopharmaceuticals, Clinical Medicine, Clinical Research Methods, Clinical Sciences, Clinical Site Management, Clinical Study Management, Clinical Testing, Clinical Trial Planning, Clinical Trials Monitoring, Data Analysis, Data Reporting, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Healthcare Innovation, Management Process, Medical Research, Monitoring Control, Organizational Performance Management, Problem Solving, Protocol Adherence {+ 4 more}

Preferred Skills : Job Posting End Date : 07 / 15 / 2025

BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day

BEFORE

the job posting end date.

Requisition ID : R

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