Clinical Research Associate II

Monroe Consulting Group, an Executive Recruitment firm's Healthcare Division, is partnering with a world-leading organisation in the Healthcare industry to hire a Clinical Research Associate II to be based in Kuala Lumpur, Malaysia.

Position Overview

The Clinical Research Associate II is responsible for conducting remote and on-site monitoring activities to ensure clinical trials are performed in accordance with approved protocols, regulatory requirements, and ICH-GCP guidelines.
This role plays a critical part in safeguarding participant well-being, maintaining data integrity, ensuring audit readiness, and supporting the successful delivery of clinical research programmes.

Key Responsibilities

• Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.
• Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
• Assess investigational product through physical inventory and records review.
• Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
• May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.
• Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.
• Participates in investigator meetings as necessary.
• May help to identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
• Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
• Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
• Provides trial status tracking and progress update reports to the team as required. Ensures study systems are complete, accurate and updated per agreed study conventions (e.g. Clinical Trial Management System).
• Facilitates effective communication between investigative sites, the client company and internal project teams through written, oral and/or electronic contacts. Responds to company, client and applicable regulatory requirements/audits/inspections.
• Maintains and completes administrative tasks such as expense reports and time sheets in a timely manner.
• Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members. Contributes to other project work and initiatives for process improvement, as required.

Key Requirements

• Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic/vocational qualification.
• Minimal clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years) in a clinical environment where experience is gained in clinical trials, medical terminology, medical research, clinical research or healthcare; or experience in a health sciences field with formal training in medical terminology and anatomy may be considered.
• Valid driving licence where applicable.
• In some cases, an equivalency consisting of a combination of appropriate education, training and/or directly related experience will be considered sufficient to meet the requirements of the role.

• Basic medical/therapeutic area knowledge and understanding of medical terminology.
• Ability to attain and maintain a working knowledge of ICH GCPs and applicable regulations and procedural documents.
• Ability to manage Risk Based Monitoring concepts and processes.
• Good computer skills, including solid knowledge of Microsoft Office and the ability to learn appropriate software.
• Experience with SDR, SDV and CRF review.
• Knowledge of Clinical Trial Management Systems and clinical trial processes.
• Good English language and grammar skills.

• Good oral and written communication skills, with the ability to communicate effectively with medical personnel.
• Good interpersonal skills.
• Ability to maintain customer focus through the utilisation of strong listening skills, attention to detail and the ability to perceive customer's underlying issues.
• Good organisational and time management skills.
• Ability to remain flexible and adaptable across a wide range of scenarios.
• Well-developed critical thinking skills, including a critical mindset, in-depth investigation for appropriate root cause analysis and problem solving.
• Ability to work effectively both independently and as part of a team.
• Strong attention to detail and commitment to compliance, quality, and data integrity.