Job Description

Open for Kuala Lumpur, Putrajaya, Selangor, Kuantan, Kuching, & Johor Bahru.

• Fresh Graduates and Nursing Backgrounds are encouraged to apply

JOB SUMMARY (Major functions of the position)The Study Coordinator (SC) is responsible for a variety of activities essential to the conduct of clinical trials at the site. This includes trial start-up activities, ongoing study management, and coordination of trial subjects at every stage of their clinical trial journey. The SC is the main point of contact for trial subjects and the study\xe2\x80\x99s Sponsor. The SC works with the Principal Investigator (PI) to ensure patient safety and the integrity of data collected, in accordance with study protocol requirements, Good Clinical Practice (GCP), and applicable regulatory requirements.KEY RESPONSIBILITIES1. Carry out day-to-day operations at the site levela) Trial planning

• Manage and coordinate feasibility studies received from the Feasibility Team, including meetings with new and potential Investigators. Follow up on the completion of feasibility questionnaires within timelines.
• Provide site-related documents and information for Ethics Committee applications.
• Support trial budget review, in association with CRM\xe2\x80\x99s Budget Review Committee (BRC).

b) Trial conduct at sitei) Coordination

• Perform tasks as delegated by the PI in accordance with the protocol, Standard Operating Procedures (SOP), and applicable guidelines.
• Proactively assist in finding potential subjects/healthy volunteers eligible to participate in the trial by performing pre-screening activities as delegated.
• Schedule and manage subject visits. Assist the Investigator during subject visits as per trial protocol requirements.
• Act as a liaison between Investigators and other clinical research stakeholders (including CROs/Sponsors, Regulatory Agencies, etc.) to support trial-related activities at the site, including site visits from Sponsor/CRO (e.g., SIV, SMV, CoV), audits, and inspections as appropriate.
• Collect, process, and ship biological specimens as per trial protocol requirements.
• Manage trial ancillary supplies, including storage, record of resupply, dispensing, and maintaining accountability of the supplies.
• Handle and manage Investigational Product (IP), including receival, storage, record of IP supply, dispensing, temperature excursion reporting, and maintaining accountability of IPs as delegated by the PI.

ii) Data Collection

• Ensure timely and accurate completion of Case Report Form (CRF)/e-CRF and resolution of queries.

iii) Others

• Guide and support Investigators on the payment process of trial budgets, including payment tracker completion, submission, and disbursement.
• Assist Investigators in subject safety management, including timely reporting of Serious Adverse Events (SAEs) to appropriate authorities.
• Maintain essential documents in Investigator Site Files (ISF) for assigned trials and make records available for review.
• Ensure trial practices reflect ethical and legal standards for clinical trials, including reporting conflicts of interest.
• Adhere to all Standard Operating Procedures and guidelines provided under the Quality Management System (QMS) ISO 9001:2015 and Anti-Bribery Management System (ABMS) ISO 37001 requirements.

2. Other Administrative Support

• Update the Investigator database from hospital and/or satellite sites, Investigator Good Clinical Practice (GCP) certification list, and feasibility log.
• Update Industry Sponsored Research (ISR) status, including recruitment progress, upcoming new trials, ongoing trials, and closure status of the trials in CRMx on a monthly basis.
• Inform and update the ARM on any new potential trials at the project site.

3. As required, assigned by ARM

• The SC may need to travel to send, receive, or retrieve biological samples/reports from external vendors.
• The SC may need to travel to engage with external relevant parties to ensure trial-related procedures are arranged accordingly.
• An under-utilized SC may need to mobilize from the current site to other project sites performing trial-related activities as agreed by investigators and approved by the Head of Clinical Operations.

BASIC JOB REQUIREMENTS

• Degree in Science, Allied Health Science, Medical, or Nursing.
• Strong organizational skills.
• Meticulous attention to detail.
• Able to work independently to meet deadlines.
• Excellent communication (verbal and written) and interpersonal skills.
• Proficient in standard computer programs, including the MS Office suite.
• Preferably GCP-certified.
• Demonstrate basic knowledge of clinical research and medical terminology.
• Prior experience in the research field/clinical trial.
• Adaptability to changing working situations and work assignments.
• Works well in a team but is self-driven.

Clinical Research Malaysia