Clinical Research Associate

More than just a recruitment company. At PRTR, we have been a part of our customer's success for 30 years as their total HR solutions partner. With 550 dedicated professionals and over 15,000 outsourced staff, we will continue to carry out our mission to develop a better career, a better life, and a better society, and thrive to become the No.1 people solutions organization in Southeast Asia.

Objectives

• Assisting the Clinical Project Manager in the management of all aspects of the daily operations of Phase 1 - 4 clinical studies.
• Managing activities of clinical investigative sites as they relate to Abbott Nutritional clinical studies including the pilot, proof of principle, therapeutic nutritional, pediatric nutritional, and efficacy studies to ensure successful execution of the protocol on time, within budget, and following country-specific regulations, ICH Guidelines, the Company's Standard Operating Procedures (SOPs).

Major Responsibilities

• Conducting site qualification, initiation, remote and interim monitoring, and study closeout visits for pediatric and adult nutrition and Phase 1-4 studies following the protocols, applicable regulatory guidelines, Good Clinical Practices (GCPs), ICH Guidelines, and the company's Nutrition (AN) Standard Operating Procedures (SOPs) and business processes. 
• Setting up study site management in a Clinical Trial Management System (CTMS). Collecting and managing essential documents for assigned study sites.
• Conducting all clinical site activities per the monitoring plan and following the study timelines and company objectives. This includes but is not limited to: 
• Managing the activities of clinical investigative sites across multiple protocols.
• Managing the overall activities of site personnel over whom there is no direct authority and motivating/influencing them to meet study objectives.
• Ensuring quality of data submitted from study sites and ensuring timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
• Ensuring the safety and protection of study subjects per the monitoring plan, the company's SOPs, ICH Guidelines, and country-specific regulations.
• Performing CTMS site management setup for assigned sites.
• Collecting and uploading into Sharepoint critical documents & maintaining Permanent Study Files for assigned sites throughout the life of the trial. Preparing, reviewing, submitting to the second reviewer, and sign-off on Essential Documents Packages (EDP).
• Performing on-site product inventory count and unblinded studies compared to the site’s product inventory records to identify any discrepancies.
• Preparing and making IRB submissions for sites, as needed.
• Training the study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.
• Appropriately escalating serious or outstanding issues to the Clinical Operations Project Lead or the appropriate project team member(s).
• Facilitating Quality Assurance Audit processes as indicated.
• Ensuring regulatory inspection readiness at assigned clinical sites.
• Handling the report monitoring activities and study site conduct accurately and completely. Preparing and submitting written reports, both monitoring and administrative, in a timely, concise, and objective manner.  
• Interacting and building professional and collaborative relationships with all study personnel (investigator, study coordinator), peers, and office-based personnel.  Using multiple technologies to maintain open and frequent communication with the company's personnel.

Skills, Education, Experience

• Minimum of 3-5 years of clinically-related experience, of which 3 years must be in clinical research monitoring.
• Solid knowledge of regulations governing clinical research, ICH/GCP Guidelines, and applicable local regulations.
• Strong site management and monitoring skills.
• Good written and verbal communication skills.
• Competence in the use of personal computers, including experience with word processing, spreadsheets, email, and web browser applications.
• Previous experience with electronic data capture systems is desirable.

KEY REQUIREMENTS

• Strong ability to work independently with minimal supervision.
• Comprehensive industry knowledge.