Open for Kuala Lumpur, Selangor, Seri Manjung, Johor Bahru & Kuching
- Fresh Graduates and Nursing Backgrounds are encouraged to apply
JOB SUMMARY (Major functions of the position)
Study Coordinator (SC) is responsible to perform variety of activities essential to the conduct of clinical trials at the site, including trial start-up activities, ongoing study management and coordination of trial subjects at every stage of their clinical trial journey. SC is the main point of contact for trial subjects and study’s Sponsor. The SC works with Principal Investigator (PI) in the following aspects of trial planning and trial conduct at the site. Together with PI, their work ensures the safety of the patients and the integrity of data collected, in accordance with the study protocol requirements, Good Clinical Practice (GCP) and applicable regulatory requirements.
KEY RESPONSIBILITIES
1. Carry out day-to-day operations at the site level
a) Trial planning
- Manage and coordinate feasibility study received from Feasibility Team, including meeting new and potential Investigators who are interested. To support and follow up the completion of feasibility questionnaires within timelines.
- Provide site-related documents and information for Ethics Committee application.
- Support trial budget review, in association with CRM’s Budget Review Committee (BRC).
b) Trial conduct at site i) Coordination
- Perform tasks as delegated by PI in accordance with the protocol, Standard Operating Procedures (SOP) and applicable guidelines.
- Proactively assist in finding potential subjects/healthy volunteers who may be eligible to participate in the trial by performing pre-screening activities as delegated.
- Schedule and manage subject visit. Assist Investigator during subject’s visit in accordance with trial’s protocol requirements.
- Act as liaison between Investigators and other clinical research stakeholders (including CROs/Sponsor, Regulatory Agency and others) to support trial-related activities at site including site visit from Sponsor/CRO (e.g. SIV, SMV, CoV), audits and inspection as appropriate.
- Collect, process and ship biological specimens as per trial’s protocol requirements.
- Manage trial ancillary supplies including managing the storage, record of the resupply, dispensing and maintaining the accountability of the supplies.
- Mandle and manage Investigational Product (IP), including the receival, storage and record of IP supply, dispensing, temperature excursion reporting and maintaining the accountability of IPs as delegated by the PI.
ii) Data Collection
• Ensure timely and accurate completion of Case Report Form (CRF)/e-CRF and queries resolution.
iii) Others
- Guide and support Investigators on the payment process of trial budget including but not limited to payment tracker completion, submission, and disbursement.
- Assist Investigators in subject safety management including timely reporting (Initial/Follow Up Letters (FUL)) of Serious Adverse Events (SAEs) to the 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 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, closure status of the trials in CRMx on monthly basis.
- Inform and update ARM on any new potential trials at project site.
3. As and when required, assigned by ARM:
- SC may need to travel to send, receive or retrieve biological samples/reports from external vendors.
- SC may need to travel to engage with the external relevant parties to ensure trial related procedures are arranged accordingly.
- Under-utilized SC may need to mobilize from current site to other project sites performing trial related activities as agreed by investigators and approved by Head of Clinical Operations.
BASIC JOB REQUIREMENTS
- Degree in Science, Allied Health Science, Medical and Nursing.
- Strong organizational skills.
- Meticulous, attention to detail.
- Able to work independently to meet deadlines.
- Excellent communication (verbal and written) and interpersonal skills.
- Skilled with standard computer programs including the MS Office suite.
- Preferably GCP-certified.
- Demonstrate basic knowledge of clinical research and medical terminology.
- Have prior experience in research field/clinical trial.
- Adaptability to changing working situations and work assignments.
- Works well in a team but is self-driven.
