Job Description
Clinical Research Associate (CRA)
- Based in Malaysia, named one of the Best Companies to Work for in 2019 by HR Asia
- We were awarded ‘Sponsor of the Year’ in 2019, 2020 and 2022 from Clinical Research Malaysia for the highest number of studies and total study value recorded in the country!
- We have a proud legacy of turning breakthrough science into medicines and vaccines that save and improve lives around the world. We are focused on discovering new solutions for today and the future!
- Join the premier biopharmaceutical company that has been in the business for more than 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:
- Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
- Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
- Gains an in-depth understanding of the study protocol and related procedures.
- Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
- Participates & provides inputs on site selection and validation activities.
- Performs remote and on-site monitoring & oversight activities using various tools to ensure:
- Data generated at site are complete, accurate and unbiased.
- Subjects’ right, safety and well-being are protected.
- Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
- Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
- Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
- Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed.
- Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.
- Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
- Contributes strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
- Supports and/or leads audit/inspection activities as needed.
- Following the country strategy defined by CRD and CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.
- Mentors / buddies junior CRAs on process/study requirements and performs co-monitoring visits where appropriate.
Extent of Travel:
- Ability to travel domestically and internationally approximately 65%-75% of working time. Expected travelling ~2-3 days/week.
- Current driver’s license preferred (Must have in certain countries).
Qualifications, Skills & Experience
CORE Competency Expectations:
- Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
- Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
- Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
- Hands on knowledge of Good Documentation Practices.
- Proven Skills in Site Management including management of site performance and patient recruitment.
- Demonstrated high level of monitoring skill with independent professional judgment.
- Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.
- Ability to understand and analyse data/metrics and act appropriately.
- Capable of managing complex issues, works in a solution-oriented manner.
- Performs root cause analysis and implements preventative and corrective action.
Behavioural Competency Expectations:
- Effective time management, organizational and interpersonal skills, conflict management, problem solving skills.
- Able to work highly independently across multiple protocols, sites and therapy areas.
- High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
- Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
- Demonstrates commitment to Customer focus.
- Works with high quality and compliance mind-set.
- Positive mindset, growth mindset, capable of working independently and being self-driven.
- Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices.
Experience Requirements:
Required:
- Min. 2 years of direct site management (monitoring) experience in a bio/pharma/CRO.
Educational Requirements:
Preferred:
- B.A./B.S. with strong emphasis in science and/or biology.
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:
No relocation
VISA Sponsorship:
No
Travel Requirements:
75%
Flexible Work Arrangements:
Hybrid
Shift:
Valid Driving License:
Yes
Hazardous Material(s):
