Clinical Research Assistant (CRA)

Job Purpose: This position will provide clinical support to the site principal investigator (PI) for proper conduction of Clinical studies at the site as per the study protocol, regulatory guidelines & ICH-GCP. He / She is responsible for the proper medical care of the study participants. He/ She will be conducting the study following the protocol with adequate compliance. The CRA is also obligated to ensure the project is conducted in compliance with the applicable laws and regulations to ensure the well-being of the participants.

Key Stakeholders:

Principal Investigator/ Co-investigator

Other critical stakeholders:

Site Trial coordinator, Junior Trial Manager, Senior Trial Manager, Research administrator & logistics manager, Trial Data Associate

Key Performance Indicators:

Participant Recruitment and Retention, Study Protocol Adherence, Data Entry, Patient safety & Care, Timeliness of CRF Completion, Stakeholder Collaboration

Key Responsibilities:

• Be aware of and comply with Good Clinical Practice guidelines and the applicable regulatory requirements.

• Be responsible for all trial-related medical decisions after consultation with the principal or co-investigators.

• Conduct the trial strictly according to the approved protocol to avoid any protocol deviation or violation.

• Ensure the appropriate use of the investigational medicinal product (IMP) in accordance with the approved protocol and SOPs.

• Screen, Randomize and Recruit the patients as per the study protocol.

• Be responsible for describing the details of the patient information sheet & consent form to participants or legally acceptable representatives about the benefits and risks involved in the trials and should adhere to GCP, study protocol, and other applicable ethical principles.

• Perform the POC formate assay and the laboratory formate assay as per the study protocol.

• Ensure the availability of an informed consent narrative for study monitoring/ audit when required.

• Ensure the accuracy, completeness, legibility, and timeliness of the data entry into Case Report Forms (CRF) or in handheld devices throughout the study. Data reported in the CRF, that are derived from source documents should be consistent with the source documents or the discrepancies should be explained.

• Ensure adequate reporting of Adverse Events and Serious Adverse Events in consultation with the principal investigator in AE/SAE reporting, offline or electronically as per the requirement.

• To have a supportive mindset to work beyond regular duty hours in the event of clustered methanol poisoning incidents. Timely response in such emergencies can make a significant difference, and we seek individuals who are both committed and flexible when urgency arises.

• Assist the Site trial coordinator for Query management & data clarifications as needed.

• Maintain thorough and accurate documentation as per study requirements.

• Be responsible for a blood sample collection from the research participants, processing and storage of it as per the study protocol.

• Support Study monitoring or audit as when required.

• To proactively collect and input all poisoning related data (as per established CRF) promptly and, when necessary , collect patient blood samples in line with the standard operating procedure (SOP). This ensures accurate reporting and supports effective case management.

• To work enthusiastically and devotedly on multiple current and future clinical studies under the Toxicology Society of Bangladesh.

• Perform other job-related duties as required